Wound Healing and Prevention
Conditions
Keywords
surgical complication, Negative-Pressure Wound Therapy (NPWT), negative pressure, knee arthroplasty, abdominal incision
Brief summary
Smith & Nephew are assessing a new investigational single use NPWT system.
Detailed description
Smith & Nephew are assessing a new investigational single use NPWT system. There is a significant amount of clinical evidence to show that NPWT may reduce oedema, increase healing and reduce chance of infection, through maintenance of pressure therapy, in closed incisions. Subjects with abdominal incisions and knee incisions following knee surgery will be recruited to the study and receive NPWT for 7 days. The performance of the system will be logged by the device and acceptability of the device will be assessed by patient and clinician. Safety will be assessed with a 30 day follow up to assess complications and device related events.
Interventions
DEVICENegative-Pressure Wound Therapy (NPWT)
Investigational single use disposable negative pressure system. The system is capable of delivering up to 80 mm Hg negative pressure to a wound or surgical incision site and managing low to moderate levels of exudate or fluid generated by the wound or incision. The therapy may be administered for up to 7 days.
Sponsors
Smith & Nephew, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject must provide written informed consent. * Subjects eighteen (18) years of age or older. * Willing and able to make all required study visits. * Able to follow instructions. * Subject is suitable to participate in the study in the opinion of the Investigator * In Orthopaedic surgery: subject is scheduled for an elective primary knee replacement arthroplasty and American Society of Anesthesiologists (ASA) score of 2-3 (Phase 1 only) * In Abdominal surgery: subject is scheduled for an elective open or laparoscopic gastrointestinal and/or gynaecological surgery with incision ≥5 cm and has an ASA score of 2-3. * Immediately after the surgery, subject will have one suitable closed abdominal or knee surgery incision (if there is more than one incision, then the clinician should choose the one which, in their opinion, is most suited for Negative Pressure Wound Therapy) that fits under the absorbent dressing area of the appropriate Negative Pressure dressing sizes .
Exclusion criteria
* Contraindications (per the Investigator Brochure) or hypersensitivity to the use of the investigational product or their components (e.g. silicone adhesives and polyurethane films \[direct contact with incision\], acrylic adhesives \[direct contact with skin\], polyethylene fabrics and super-absorbent powders \[polyacrylates\]) within the dressing). * Subjects with extremely fragile skin who require the use of SECURA™ non-sting barrier skin wipes and have hypersensitivity to the ingredients in the wipes * Participation in the treatment period of another similar clinical trial (wound care related) within thirty (30) days of operative visit or during the study. * Subjects with skin features (e.g. tattoos, skin colour, pre-existing scarring) which in the opinion of the Investigator, will interfere with the study assessments. * Subjects attending for an operation at the same surgery site (anatomical location) within the last 3 months * Subjects undergoing a procedure as part of palliative care (to be confirmed during surgery). * Subjects where the area of the device would be placed on a load-bearing anatomical location (i.e. areas vulnerable to pressure damage). * Subjects with incisions that are actively bleeding unless haemostasis has been achieved (to be confirmed during surgery). * Subjects with infected skin lesions or incisions at the time of surgery (any area of the body). * Subjects who have participated previously in this clinical trial * Subjects with a history of poor compliance with medical treatment. * Subjects with a BMI ≥ 40. * Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Negative Pressure Maintenance at Nominal 80 mmHg | 30 days post-op | Negative pressure maintenance at nominal 80 mmHg assessed as the average of the negative pressure values recorded by the device for Abdominal and Knee surgery types. This data was summarized to show an average negative pressure provided over the treatment duration. |
| Dressing Wear Time | 7 days | Dressing wear time in days as assessed of any unplanned dressing change by Abdominal and Knee surgery type. |
| Exudate Management (Occurrence of Exudate Leaks) | 7 days | Number of participants with occurrence of exudate leaks. Leakage classified as 'Any Leak' (Yes/No) by Abdominal and Knee surgery type. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | Baseline, 7 days, 14 days, and 30 days | Condition of skin under investigative single use Negative-Pressure Wound Therapy (NPWT) dressing assessed through visual inspection by the investigator at baseline, 7, 14, and 30 days. Number of participants by Abdominal and Knee surgery type where skin was categorized with any condition that applied (i.e., multiple selections possible) from the following criteria: * Healthy * Fragile * Inflamed * Erythema * Bruising * Eczematous * Dry and Flaky * Macerated * Other |
| Wound and Skin Visual Analog Scale (VAS) Score Assessment | 7 days, 14 days, and 30 days | Wound and Skin VAS score assessment at 7, 14 and 30 days. Scores range from 0 to 100 with a low score associated to a wound with a major gapping, dehiscence, severe inflammation and/or infection (i.e., poor outcome); and a high correspond to a completely healed wound with no evidence for inflammation (i.e., excellent outcome). |
| Incidence of Surgical Site Infection (SSI) | 30 days | Number of participants with incidence of Surgical Site Infection (SSI) within 30 days of surgery classified using Centers for Decease Control (CDC) criteria of: * Superficial Infection * Deep Infection * Organ Space Infection * Other |
| Level of Pain During Wear of the Investigational Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed by VAS Score | 4 days and 7 days | Level of pain during wear by investigational single use Negative-Pressure Wound Therapy (NPWT) Dressing at day 4 and day 7 assessed using a Visual Analog Scale (VAS) from 0 to 100 where a score of 0 indicated no pain and 100 indicated maximum pain. |
| Level of Pain at Dressing Removal of the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed by VAS Score | 7 days | Level of pain during dressing removal by Abdominal and Knee surgery type at treatment discontinuation (up to day 7) assessed using a Visual Analog Scale (VAS) from 0 to 100 where a score of 0 indicated no pain and 100 indicated maximum pain. |
| Range of Motion Assessment (ROM) for the Knee | 30 days | Range of Motion (ROM) assessment for the knee at pre-operative visit, post-operative visit, 7, 14 and 30 days. |
| Incidence of Surgical Site Complications (SSC) | 30 days | Number of participants with incidence of Surgical Site Complications (SSC) within 30 days of surgery categorized as: * Deep Dehiscence * Superficial Dehiscence * Partial Dehiscence * Total Dehiscence * Seroma * Necrosis * Hematoma * Suture Abscess * Other |
| Condition of Peri-Wound Skin Assessed Through Visual Inspection | Baseline, 7 days, 14 days, and 30 days | Condition of peri-wound skin assessed through visual inspection by the investigator at baseline, 7, 14, and 30 days. Number of participants by Abdominal and Knee surgery type where skin was categorized with any condition that applied (i.e., multiple selections possible) from the following criteria: * Healthy * Fragile * Inflamed * Erythema * Bruising * Eczematous * Dry and Flaky * Macerated * Other |
Countries
United Kingdom
Participant flow
Recruitment details
Enrollment began 12 July 2019 to 01 February 2022 across 8 investigative sites.
Participants by arm
| Arm | Count |
|---|---|
| Abdominal Abdominal surgery type with investigational single use NPWT dressing | 68 |
| Knee Knee surgery type with investigational single use NPWT dressing | 22 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Abdominal | Knee | Total |
|---|---|---|---|
| Age, Continuous | 66.9 years STANDARD_DEVIATION 11.9 | 70.4 years STANDARD_DEVIATION 7.6 | 67.8 years STANDARD_DEVIATION 11.1 |
| Body Mass Index (BMI) | 28.0 kg/m^2 STANDARD_DEVIATION 5.2 | 31.5 kg/m^2 STANDARD_DEVIATION 3.4 | 28.9 kg/m^2 STANDARD_DEVIATION 5 |
| Race/Ethnicity, Customized Ethnicity Any Other White Background | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Ethnicity Not Stated | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Ethnicity White and Asian Mixed | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Ethnicity White British | 63 Participants | 22 Participants | 85 Participants |
| Race/Ethnicity, Customized Ethnicity White Irish | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Caucasian | 67 Participants | 22 Participants | 89 Participants |
| Region of Enrollment United Kingdom | 68 participants | 22 participants | 90 participants |
| Sex: Female, Male Female | 26 Participants | 14 Participants | 40 Participants |
| Sex: Female, Male Male | 42 Participants | 8 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 68 | 0 / 22 |
| other Total, other adverse events | 45 / 68 | 19 / 22 |
| serious Total, serious adverse events | 19 / 68 | 1 / 22 |
Outcome results
Primary
Dressing Wear Time
Dressing wear time in days as assessed of any unplanned dressing change by Abdominal and Knee surgery type.
Time frame: 7 days
Population: Full Analysis Set (FAS) population included enrolled participants with available data for the surgery type specified.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abdominal | Dressing Wear Time | 5.7 days | Standard Deviation 2.4 |
| Knee | Dressing Wear Time | 5.3 days | Standard Deviation 2.1 |
Primary
Exudate Management (Occurrence of Exudate Leaks)
Number of participants with occurrence of exudate leaks. Leakage classified as 'Any Leak' (Yes/No) by Abdominal and Knee surgery type.
Time frame: 7 days
Population: Full Analysis Set (FAS) population included enrolled participants with available data for the surgery type specified.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Abdominal | Exudate Management (Occurrence of Exudate Leaks) | Any Leak: Yes | 5 Participants |
| Abdominal | Exudate Management (Occurrence of Exudate Leaks) | Any Leak: No | 63 Participants |
| Knee | Exudate Management (Occurrence of Exudate Leaks) | Any Leak: Yes | 12 Participants |
| Knee | Exudate Management (Occurrence of Exudate Leaks) | Any Leak: No | 10 Participants |
Primary
Negative Pressure Maintenance at Nominal 80 mmHg
Negative pressure maintenance at nominal 80 mmHg assessed as the average of the negative pressure values recorded by the device for Abdominal and Knee surgery types. This data was summarized to show an average negative pressure provided over the treatment duration.
Time frame: 30 days post-op
Population: Full Analysis Set (FAS) population included enrolled participants with available data for the surgery type specified.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abdominal | Negative Pressure Maintenance at Nominal 80 mmHg | -71.5 millimeters of mercury (mmHg) | Standard Deviation 25.1 |
| Knee | Negative Pressure Maintenance at Nominal 80 mmHg | -56.0 millimeters of mercury (mmHg) | Standard Deviation 28.2 |
Secondary
Condition of Peri-Wound Skin Assessed Through Visual Inspection
Condition of peri-wound skin assessed through visual inspection by the investigator at baseline, 7, 14, and 30 days. Number of participants by Abdominal and Knee surgery type where skin was categorized with any condition that applied (i.e., multiple selections possible) from the following criteria: * Healthy * Fragile * Inflamed * Erythema * Bruising * Eczematous * Dry and Flaky * Macerated * Other
Time frame: Baseline, 7 days, 14 days, and 30 days
Population: Full Analysis Set (FAS) population included enrolled participants with available data for the specified assessment at the time point indicated. Because multiple responses were possible, Healthy skin could be recorded along with any other conditions. Where this occurred, the investigator believed the other condition(s) selected did not affect the healthiness of the skin.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 14 Days: Healthy | 59 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | Baseline: Eczematous | 0 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 14 Days: Fragile | 2 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 7 Days: Fragile | 1 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 14 Days: Inflamed | 7 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | Baseline: Erythema | 2 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 14 Days: Erythema | 9 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 7 Days: Inflamed | 4 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 14 Days: Bruising | 17 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | Baseline: Dry and Flaky | 0 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 14 Days: Eczematous | 2 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 7 Days: Erythema | 2 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 14 Days: Dry and Flaky | 5 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | Baseline: Inflamed | 2 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 14 Days: Macerated | 1 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 7 Days: Bruising | 35 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 14 Days: Other | 6 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | Baseline: Macerated | 0 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 30 Days: Healthy | 59 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 7 Days: Eczematous | 1 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 30 Days: Fragile | 4 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | Baseline: Bruising | 0 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 30 Days: Inflamed | 3 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 7 Days: Dry and Flaky | 3 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 30 Days: Erythema | 3 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | Baseline: Other | 1 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 30 Days: Bruising | 0 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 7 Days: Macerated | 1 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 30 Days: Eczematous | 1 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | Baseline: Fragile | 4 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 30 Days: Dry and Flaky | 9 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 7 Days: Other | 4 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 30 Days: Macerated | 0 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 7 Days: Healthy | 59 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 30 Days: Other | 4 Participants |
| Abdominal | Condition of Peri-Wound Skin Assessed Through Visual Inspection | Baseline: Healthy | 68 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 30 Days: Other | 2 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | Baseline: Healthy | 22 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | Baseline: Fragile | 0 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | Baseline: Inflamed | 0 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | Baseline: Erythema | 0 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | Baseline: Bruising | 1 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | Baseline: Eczematous | 0 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | Baseline: Dry and Flaky | 0 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | Baseline: Macerated | 0 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | Baseline: Other | 0 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 7 Days: Healthy | 19 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 7 Days: Fragile | 0 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 7 Days: Inflamed | 2 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 7 Days: Erythema | 1 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 7 Days: Bruising | 12 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 7 Days: Eczematous | 0 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 7 Days: Dry and Flaky | 1 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 7 Days: Macerated | 0 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 7 Days: Other | 3 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 14 Days: Healthy | 21 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 14 Days: Fragile | 0 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 14 Days: Inflamed | 3 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 14 Days: Erythema | 2 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 14 Days: Bruising | 5 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 14 Days: Eczematous | 0 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 14 Days: Dry and Flaky | 0 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 14 Days: Macerated | 0 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 14 Days: Other | 3 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 30 Days: Healthy | 22 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 30 Days: Fragile | 0 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 30 Days: Inflamed | 1 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 30 Days: Erythema | 0 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 30 Days: Bruising | 2 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 30 Days: Eczematous | 0 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 30 Days: Dry and Flaky | 4 Participants |
| Knee | Condition of Peri-Wound Skin Assessed Through Visual Inspection | 30 Days: Macerated | 0 Participants |
Secondary
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection
Condition of skin under investigative single use Negative-Pressure Wound Therapy (NPWT) dressing assessed through visual inspection by the investigator at baseline, 7, 14, and 30 days. Number of participants by Abdominal and Knee surgery type where skin was categorized with any condition that applied (i.e., multiple selections possible) from the following criteria: * Healthy * Fragile * Inflamed * Erythema * Bruising * Eczematous * Dry and Flaky * Macerated * Other
Time frame: Baseline, 7 days, 14 days, and 30 days
Population: Full Analysis Set (FAS) population included enrolled participants with available data for the specified assessment at the time point indicated. Because multiple responses were possible, Healthy skin could be recorded along with any other conditions. Where this occurred, the investigator believed the other condition(s) selected did not affect the healthiness of the skin.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 14 Days: Healthy | 64 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | Baseline: Eczematous | 0 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 14 Days: Fragile | 2 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 7 Days: Fragile | 0 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 14 Days: Inflamed | 1 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | Baseline: Erythema | 0 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 14 Days: Erythema | 1 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 7 Days: Inflamed | 1 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 14 Days: Bruising | 6 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | Baseline: Dry and Flaky | 0 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 14 Days: Eczematous | 1 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 7 Days: Erythema | 1 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 14 Days: Dry and Flaky | 1 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | Baseline: Inflamed | 0 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 14 Days: Macerated | 0 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 7 Days: Bruising | 10 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 14 Days: Other | 2 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | Baseline: Macerated | 0 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 30 Days: Healthy | 60 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 7 Days: Eczematous | 0 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 30 Days: Fragile | 1 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | Baseline: Bruising | 13 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 30 Days: Inflamed | 1 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 7 Days: Dry and Flaky | 1 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 30 Days: Erythema | 3 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | Baseline: Other | 0 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 30 Days: Bruising | 0 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 7 Days: Macerated | 0 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 30 Days: Eczematous | 1 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | Baseline: Fragile | 1 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 30 Days: Dry and Flaky | 3 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 7 Days: Other | 3 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 30 Days: Macerated | 0 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 7 Days: Healthy | 62 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 30 Days: Other | 1 Participants |
| Abdominal | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | Baseline: Healthy | 68 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 30 Days: Other | 0 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | Baseline: Healthy | 22 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | Baseline: Fragile | 0 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | Baseline: Inflamed | 0 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | Baseline: Erythema | 0 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | Baseline: Bruising | 0 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | Baseline: Eczematous | 0 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | Baseline: Dry and Flaky | 0 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | Baseline: Macerated | 0 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | Baseline: Other | 0 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 7 Days: Healthy | 19 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 7 Days: Fragile | 0 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 7 Days: Inflamed | 0 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 7 Days: Erythema | 0 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 7 Days: Bruising | 3 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 7 Days: Eczematous | 0 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 7 Days: Dry and Flaky | 0 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 7 Days: Macerated | 0 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 7 Days: Other | 3 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 14 Days: Healthy | 21 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 14 Days: Fragile | 0 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 14 Days: Inflamed | 1 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 14 Days: Erythema | 0 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 14 Days: Bruising | 0 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 14 Days: Eczematous | 0 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 14 Days: Dry and Flaky | 1 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 14 Days: Macerated | 0 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 14 Days: Other | 0 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 30 Days: Healthy | 21 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 30 Days: Fragile | 0 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 30 Days: Inflamed | 0 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 30 Days: Erythema | 0 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 30 Days: Bruising | 0 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 30 Days: Eczematous | 0 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 30 Days: Dry and Flaky | 0 Participants |
| Knee | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | 30 Days: Macerated | 0 Participants |
Secondary
Incidence of Surgical Site Complications (SSC)
Number of participants with incidence of Surgical Site Complications (SSC) within 30 days of surgery categorized as: * Deep Dehiscence * Superficial Dehiscence * Partial Dehiscence * Total Dehiscence * Seroma * Necrosis * Hematoma * Suture Abscess * Other
Time frame: 30 days
Population: Full Analysis Set (FAS) population included all enrolled participants with available data for the specified assessment. Out of 90 (68 Abdominal, 22 Knee) participants overall, 10 (9 Abdominal, 1 Knee) participants experienced at least one Surgical Site Complication (SSC) indicated by the given criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Abdominal | Incidence of Surgical Site Complications (SSC) | Suture Abscess | 0 Participants |
| Abdominal | Incidence of Surgical Site Complications (SSC) | Deep Dehiscence | 2 Participants |
| Abdominal | Incidence of Surgical Site Complications (SSC) | Haematoma | 2 Participants |
| Abdominal | Incidence of Surgical Site Complications (SSC) | Superficial Dehiscence | 6 Participants |
| Abdominal | Incidence of Surgical Site Complications (SSC) | Other | 2 Participants |
| Abdominal | Incidence of Surgical Site Complications (SSC) | Partial Dehiscence | 5 Participants |
| Abdominal | Incidence of Surgical Site Complications (SSC) | Total Dehiscence | 1 Participants |
| Abdominal | Incidence of Surgical Site Complications (SSC) | Necrosis | 0 Participants |
| Abdominal | Incidence of Surgical Site Complications (SSC) | Seroma | 0 Participants |
| Knee | Incidence of Surgical Site Complications (SSC) | Partial Dehiscence | 0 Participants |
| Knee | Incidence of Surgical Site Complications (SSC) | Necrosis | 0 Participants |
| Knee | Incidence of Surgical Site Complications (SSC) | Haematoma | 0 Participants |
| Knee | Incidence of Surgical Site Complications (SSC) | Suture Abscess | 0 Participants |
| Knee | Incidence of Surgical Site Complications (SSC) | Other | 1 Participants |
| Knee | Incidence of Surgical Site Complications (SSC) | Seroma | 0 Participants |
| Knee | Incidence of Surgical Site Complications (SSC) | Deep Dehiscence | 0 Participants |
| Knee | Incidence of Surgical Site Complications (SSC) | Superficial Dehiscence | 0 Participants |
| Knee | Incidence of Surgical Site Complications (SSC) | Total Dehiscence | 0 Participants |
Secondary
Incidence of Surgical Site Infection (SSI)
Number of participants with incidence of Surgical Site Infection (SSI) within 30 days of surgery classified using Centers for Decease Control (CDC) criteria of: * Superficial Infection * Deep Infection * Organ Space Infection * Other
Time frame: 30 days
Population: Full Analysis Set (FAS) population included all enrolled participants with available data for the specified assessment. Out of 90 (68 Abdominal, 22 Knee) participants overall, 5 (5 Abdominal, 0 Knee) participants experienced at least one Surgical Site Infection (SSI) indicated by the given criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Abdominal | Incidence of Surgical Site Infection (SSI) | Superficial Infection | 3 Participants |
| Abdominal | Incidence of Surgical Site Infection (SSI) | Deep Infection | 2 Participants |
| Abdominal | Incidence of Surgical Site Infection (SSI) | Organ Space Infection | 1 Participants |
| Abdominal | Incidence of Surgical Site Infection (SSI) | Other | 1 Participants |
| Knee | Incidence of Surgical Site Infection (SSI) | Other | 0 Participants |
| Knee | Incidence of Surgical Site Infection (SSI) | Superficial Infection | 0 Participants |
| Knee | Incidence of Surgical Site Infection (SSI) | Organ Space Infection | 0 Participants |
| Knee | Incidence of Surgical Site Infection (SSI) | Deep Infection | 0 Participants |
Secondary
Level of Pain at Dressing Removal of the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed by VAS Score
Level of pain during dressing removal by Abdominal and Knee surgery type at treatment discontinuation (up to day 7) assessed using a Visual Analog Scale (VAS) from 0 to 100 where a score of 0 indicated no pain and 100 indicated maximum pain.
Time frame: 7 days
Population: Full Analysis Set (FAS) population included enrolled participants with available data for the specified assessment at the time point indicated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abdominal | Level of Pain at Dressing Removal of the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed by VAS Score | 12.6 score on a scale | Standard Deviation 18.3 |
| Knee | Level of Pain at Dressing Removal of the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed by VAS Score | 31.6 score on a scale | Standard Deviation 30.7 |
Secondary
Level of Pain During Wear of the Investigational Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed by VAS Score
Level of pain during wear by investigational single use Negative-Pressure Wound Therapy (NPWT) Dressing at day 4 and day 7 assessed using a Visual Analog Scale (VAS) from 0 to 100 where a score of 0 indicated no pain and 100 indicated maximum pain.
Time frame: 4 days and 7 days
Population: Full Analysis Set (FAS) population included enrolled participants with available data for the specified assessment at the time point indicated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abdominal | Level of Pain During Wear of the Investigational Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed by VAS Score | 4 Days | 20.2 score on a scale | Standard Deviation 24.7 |
| Abdominal | Level of Pain During Wear of the Investigational Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed by VAS Score | 7 Days | 14.2 score on a scale | Standard Deviation 20.5 |
| Knee | Level of Pain During Wear of the Investigational Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed by VAS Score | 4 Days | 41.8 score on a scale | Standard Deviation 28.8 |
| Knee | Level of Pain During Wear of the Investigational Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed by VAS Score | 7 Days | 35.4 score on a scale | Standard Deviation 26 |
Secondary
Range of Motion Assessment (ROM) for the Knee
Range of Motion (ROM) assessment for the knee at pre-operative visit, post-operative visit, 7, 14 and 30 days.
Time frame: 30 days
Population: Data reported for knee extension in Knee Group interpreted as negative (extension deficit) or positive (actual extension). Therefore, ROM can be the sum or difference of reported knee flexion \& extension. Because different Investigators applied different interpretations, there is low confidence in reliability of ROM data. Further investigation is required with additional clinical evaluations before the investigational NPWT device can be considered suitable for consideration in TKA subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abdominal | Range of Motion Assessment (ROM) for the Knee | Pre-Operative - Flexion | 102.5 degrees | Standard Deviation 17.2 |
| Abdominal | Range of Motion Assessment (ROM) for the Knee | Pre-Operative - Extension Angle | 9.4 degrees | Standard Deviation 7.7 |
| Abdominal | Range of Motion Assessment (ROM) for the Knee | Pre-Operative - ROM | 93.1 degrees | Standard Deviation 20.7 |
| Abdominal | Range of Motion Assessment (ROM) for the Knee | Post-Operative - Flexion | 61.6 degrees | Standard Deviation 20.3 |
| Abdominal | Range of Motion Assessment (ROM) for the Knee | Post-Operative - Extension Angle | 6.6 degrees | Standard Deviation 5.9 |
| Abdominal | Range of Motion Assessment (ROM) for the Knee | Post-Operative - ROM | 54.9 degrees | Standard Deviation 21.6 |
| Abdominal | Range of Motion Assessment (ROM) for the Knee | Day 7 (Pre-Dressing Removal) - Flexion | 75.5 degrees | Standard Deviation 16.1 |
| Abdominal | Range of Motion Assessment (ROM) for the Knee | Day 7 (Pre-Dressing Removal) - Extension Angle | 14.2 degrees | Standard Deviation 9.5 |
| Abdominal | Range of Motion Assessment (ROM) for the Knee | Day 7 (Pre-Dressing Removal) - ROM | 61.6 degrees | Standard Deviation 16.6 |
| Abdominal | Range of Motion Assessment (ROM) for the Knee | Day 7 (Post-Dressing Removal) - Flexion | 75.6 degrees | Standard Deviation 19.7 |
| Abdominal | Range of Motion Assessment (ROM) for the Knee | Day 7 (Post-Dressing Removal) - Extension Angle | 11.2 degrees | Standard Deviation 6.9 |
| Abdominal | Range of Motion Assessment (ROM) for the Knee | Day 7 (Post-Dressing Removal) - ROM | 64.4 degrees | Standard Deviation 18.2 |
| Abdominal | Range of Motion Assessment (ROM) for the Knee | Day 14 - Flexion | 86.3 degrees | Standard Deviation 17.2 |
| Abdominal | Range of Motion Assessment (ROM) for the Knee | Day 14 - Extension Angle | 10.2 degrees | Standard Deviation 6.3 |
| Abdominal | Range of Motion Assessment (ROM) for the Knee | Day 14 - ROM | 76.0 degrees | Standard Deviation 18.1 |
| Abdominal | Range of Motion Assessment (ROM) for the Knee | Day 30 - Flexion | 100.4 degrees | Standard Deviation 15.8 |
| Abdominal | Range of Motion Assessment (ROM) for the Knee | Day 30 - Extension Angle | 8.7 degrees | Standard Deviation 5.6 |
| Abdominal | Range of Motion Assessment (ROM) for the Knee | Day 30 - ROM | 91.6 degrees | Standard Deviation 15.9 |
Secondary
Wound and Skin Visual Analog Scale (VAS) Score Assessment
Wound and Skin VAS score assessment at 7, 14 and 30 days. Scores range from 0 to 100 with a low score associated to a wound with a major gapping, dehiscence, severe inflammation and/or infection (i.e., poor outcome); and a high correspond to a completely healed wound with no evidence for inflammation (i.e., excellent outcome).
Time frame: 7 days, 14 days, and 30 days
Population: Full Analysis Set (FAS) population included enrolled participants with available data for the specified assessment at the time point indicated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abdominal | Wound and Skin Visual Analog Scale (VAS) Score Assessment | 7 Days | 79.0 score on a scale | Standard Deviation 26.7 |
| Abdominal | Wound and Skin Visual Analog Scale (VAS) Score Assessment | 14 Days | 81.4 score on a scale | Standard Deviation 26.1 |
| Abdominal | Wound and Skin Visual Analog Scale (VAS) Score Assessment | 30 Days | 85.0 score on a scale | Standard Deviation 27.6 |
| Knee | Wound and Skin Visual Analog Scale (VAS) Score Assessment | 7 Days | 89.9 score on a scale | Standard Deviation 7.4 |
| Knee | Wound and Skin Visual Analog Scale (VAS) Score Assessment | 14 Days | 89.4 score on a scale | Standard Deviation 10.4 |
| Knee | Wound and Skin Visual Analog Scale (VAS) Score Assessment | 30 Days | 95.0 score on a scale | Standard Deviation 5.6 |