Arthroplasties, Hip Replacement, Arthroplasties, Knee Replacement
Conditions
Brief summary
The overall rationale for this investigation is to evaluate the clinical performance potential for Mepilex Border Post-Op Ag in the ability to minimize the risk of skin related post-operative wound complications such as blistering, maceration and redness at the incision and surrounding skin.
Detailed description
This was a descriptive, open, prospective, non-controlled clinical investigation conducted on 21 enrolled subjects at one site in the United states of America (USA). The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty with a possibility to participate in a follow-up visit 7 days after surgery. The primary purpose was to investigate if there was any skin damage under the dressing from operation day to last visit. Performance of the dressing as well as comfort, conformability, acceptability and pain at dressing removal was also followed-up until post-op day 7.
Interventions
To investigate if there was any skin damage under the dressing from operation day to last visit.
Sponsors
Molnlycke Health Care AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. Available for a follow-up visit including dressing change 7 days after surgery 3. Plan for elective primary hip or knee arthroplasty 4. Plan for incision size ≤18 cm 5. Provision of informed consent i.e. subject must be able to understand and sign the Patient Information and Consent Form 6. Undergoing elective primary arthroplasty of the hip or knee.
Exclusion criteria
1. Known allergy/hypersensitivity to any of the components of the dressing 2. Multi-trauma 3. Undergoing arthroplasty due to tumor 4. Previous incision at the same knee or same side of the hip 5. Wound at the surgical site prior to surgery 6. Neurological deficit of operated side (hemiplegia, etc.) 7. Documented skin disease at time of enrollment, as judged by the investigator 8. Previously enrolled in the present investigation 9. Inclusion in other ongoing investigations at present that would preclude the subject from participating in this investigation as judged by the investigator 10. Involvement in the planning and conduct of the clinical investigation (applies to all MHC staff, investigational site staff and third party vendor) 11. Dressing size does not fit the incision area (\>18 cm) 12. Complications that would increase wound risks if investigational dressing is applied
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Damage to the Incision and Surrounding Skin | Daily visits, up to 7 days | The primary outcome is damage to the incision and surrounding skin from operation day to last visit in terms of: * Blistering (Yes/No) by visit * Redness under dressing (Yes/No) by visit * Redness outside dressing (Yes/No) by visit * Maceration under dressing (Yes/No) by visit * Maceration outside dressing (Yes/No) by visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Dressing Sticking to the Staples/Sutures | Daily visits, up to 7 days | Nurse/ Investigator evaluate: Dressing sticks to the staples/sutures (No/Yes) |
| Number of Participants With Bleeding Caused by Dressing Removal | Daily visits, up to 7 days | Nurse/ Investigator evaluate: Bleeding caused by dressing removal (No/Yes) |
| Participants' Dressing Wear Time (Days) | 7 days | The number of days the dressing can stay on are evaluated |
| Number of Participants With Leakage of the Dressing | Daily visits, up to 7 days | Nurse/ Investigator evaluate: Leakage (No/Yes) |
| Evaluation of the Dressing Capacity of Handling Blood | Daily visits, up to 7 days | Nurse or Investigator evaluate: Poor, Good, Very Good,Very Good, Excellent on a Likert scale. |
| Residuals of the Dressing Material in the Wound or Surrounding Skin at Any Visit (for Patients With at Least One Dressing Change) | Daily visits, up to 7 days | Residuals of the dressing material in the wound or surrounding skin at any visit (for patients with at least one dressing change). Nurse/ Investigator evaluate with No/Yes |
| Number of Dressing Changes Per Subject | Daily visits, up to 7 days | To evaluate the number of dressing changes per subject |
Countries
United States
Participant flow
Recruitment details
Investigation period: Feb 2017 - March 2017. The study was conducted on 21 enrolled subjects at one site in the US. Subjects included were 18 years, and above, undergoing elective primary hip or knee arthroplasty.
Participants by arm
| Arm | Count |
|---|---|
| Mepilex Border Post-Op Ag Dressing A soft silicone foam dressing that absorbs wound exudate maintains a moist wound healing environment and has antimicrobial properties | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Mepilex Border Post-Op Ag Dressing | — |
|---|---|---|
| Age, Continuous | 68.4 years STANDARD_DEVIATION 5.8 | — |
| Blistering | 0 Number of blisters | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 21 Participants | — |
| Sex: Female, Male Female | 10 Participants | — |
| Sex: Female, Male Male | 11 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 1 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Primary
Number of Participants With Damage to the Incision and Surrounding Skin
The primary outcome is damage to the incision and surrounding skin from operation day to last visit in terms of: * Blistering (Yes/No) by visit * Redness under dressing (Yes/No) by visit * Redness outside dressing (Yes/No) by visit * Maceration under dressing (Yes/No) by visit * Maceration outside dressing (Yes/No) by visit
Time frame: Daily visits, up to 7 days
Population: The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| The Study Group | Number of Participants With Damage to the Incision and Surrounding Skin | Maceration Under Dressing visit 6 | 0 Participants |
| The Study Group | Number of Participants With Damage to the Incision and Surrounding Skin | Blistering visit 3 | 0 Participants |
| The Study Group | Number of Participants With Damage to the Incision and Surrounding Skin | Blistering visit 5 | 0 Participants |
| The Study Group | Number of Participants With Damage to the Incision and Surrounding Skin | Blistering visit 6 | 0 Participants |
| The Study Group | Number of Participants With Damage to the Incision and Surrounding Skin | Redness Under Dressing visit 3 | 0 Participants |
| The Study Group | Number of Participants With Damage to the Incision and Surrounding Skin | Redness Under Dressing visit 5 | 0 Participants |
| The Study Group | Number of Participants With Damage to the Incision and Surrounding Skin | Redness Under Dressing visit 6 | 5 Participants |
| The Study Group | Number of Participants With Damage to the Incision and Surrounding Skin | Redness Outside Dressing visit 3 | 0 Participants |
| The Study Group | Number of Participants With Damage to the Incision and Surrounding Skin | Redness Outside Dressing visit 5 | 0 Participants |
| The Study Group | Number of Participants With Damage to the Incision and Surrounding Skin | Redness Outside Dressing visit 6 | 2 Participants |
| The Study Group | Number of Participants With Damage to the Incision and Surrounding Skin | Maceration Under Dressing visit 3 | 0 Participants |
| The Study Group | Number of Participants With Damage to the Incision and Surrounding Skin | Maceration Under Dressing visit 5 | 0 Participants |
| The Study Group | Number of Participants With Damage to the Incision and Surrounding Skin | Maceration Outside Dressing visit 3 | 0 Participants |
| The Study Group | Number of Participants With Damage to the Incision and Surrounding Skin | Maceration Outside Dressing visit 5 | 0 Participants |
| The Study Group | Number of Participants With Damage to the Incision and Surrounding Skin | Maceration Outside Dressing visit 6 | 0 Participants |
Secondary
Evaluation of the Dressing Capacity of Handling Blood
Nurse or Investigator evaluate: Poor, Good, Very Good,Very Good, Excellent on a Likert scale.
Time frame: Daily visits, up to 7 days
Population: The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| The Study Group | Evaluation of the Dressing Capacity of Handling Blood | Poor visit 3 | 0 Participants |
| The Study Group | Evaluation of the Dressing Capacity of Handling Blood | Poor visit 5 | 0 Participants |
| The Study Group | Evaluation of the Dressing Capacity of Handling Blood | Poor visit 6 | 0 Participants |
| The Study Group | Evaluation of the Dressing Capacity of Handling Blood | Good visit 3 | 0 Participants |
| The Study Group | Evaluation of the Dressing Capacity of Handling Blood | Good visit 5 | 0 Participants |
| The Study Group | Evaluation of the Dressing Capacity of Handling Blood | Good visit 6 | 0 Participants |
| The Study Group | Evaluation of the Dressing Capacity of Handling Blood | Very good visit 3 | 0 Participants |
| The Study Group | Evaluation of the Dressing Capacity of Handling Blood | Very good visit 5 | 0 Participants |
| The Study Group | Evaluation of the Dressing Capacity of Handling Blood | Very good visit 6 | 0 Participants |
| The Study Group | Evaluation of the Dressing Capacity of Handling Blood | Excellent visit 3 | 0 Participants |
| The Study Group | Evaluation of the Dressing Capacity of Handling Blood | Excellent visit 5 | 3 Participants |
| The Study Group | Evaluation of the Dressing Capacity of Handling Blood | Excellent visit 6 | 19 Participants |
| The Study Group | Evaluation of the Dressing Capacity of Handling Blood | Not applicable visit 6 | 1 Participants |
Secondary
Number of Dressing Changes Per Subject
To evaluate the number of dressing changes per subject
Time frame: Daily visits, up to 7 days
Population: The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| The Study Group | Number of Dressing Changes Per Subject | 1.00 Number of dressing changes per subject | Standard Deviation 0 |
Secondary
Number of Participants With Bleeding Caused by Dressing Removal
Nurse/ Investigator evaluate: Bleeding caused by dressing removal (No/Yes)
Time frame: Daily visits, up to 7 days
Population: The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits..
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| The Study Group | Number of Participants With Bleeding Caused by Dressing Removal | Bleeding caused by the dressing removal visit 3 | 0 Participants |
| The Study Group | Number of Participants With Bleeding Caused by Dressing Removal | Bleeding caused by the dressing removal visit 5 | 0 Participants |
| The Study Group | Number of Participants With Bleeding Caused by Dressing Removal | Bleeding caused by the dressing removal visit 6 | 0 Participants |
Secondary
Number of Participants With Dressing Sticking to the Staples/Sutures
Nurse/ Investigator evaluate: Dressing sticks to the staples/sutures (No/Yes)
Time frame: Daily visits, up to 7 days
Population: The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| The Study Group | Number of Participants With Dressing Sticking to the Staples/Sutures | Dressing sticks to the staples visit 3 | 0 Participants |
| The Study Group | Number of Participants With Dressing Sticking to the Staples/Sutures | Dressing sticks to the staples visit 5 | 0 Participants |
| The Study Group | Number of Participants With Dressing Sticking to the Staples/Sutures | Dressing sticks to the staples visit 6 | 0 Participants |
Secondary
Number of Participants With Leakage of the Dressing
Nurse/ Investigator evaluate: Leakage (No/Yes)
Time frame: Daily visits, up to 7 days
Population: The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| The Study Group | Number of Participants With Leakage of the Dressing | Leakage visit 3 | 0 Participants |
| The Study Group | Number of Participants With Leakage of the Dressing | Leakage visit 5 | 0 Participants |
| The Study Group | Number of Participants With Leakage of the Dressing | Leakage visit 6 | 0 Participants |
| The Study Group | Number of Participants With Leakage of the Dressing | Leakage visit 2 | 0 Participants |
Secondary
Participants' Dressing Wear Time (Days)
The number of days the dressing can stay on are evaluated
Time frame: 7 days
Population: The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| The Study Group | Participants' Dressing Wear Time (Days) | 6.35 days | Standard Deviation 1.57 |
Secondary
Residuals of the Dressing Material in the Wound or Surrounding Skin at Any Visit (for Patients With at Least One Dressing Change)
Residuals of the dressing material in the wound or surrounding skin at any visit (for patients with at least one dressing change). Nurse/ Investigator evaluate with No/Yes
Time frame: Daily visits, up to 7 days
Population: The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Study Group | Residuals of the Dressing Material in the Wound or Surrounding Skin at Any Visit (for Patients With at Least One Dressing Change) | 3 Participants |