Hip Surgery Corrective, Knee Injuries
Conditions
Brief summary
The primary objective of this investigation is to evaluate if complications related to surgical wound are more common in the treatment group compared to the control group starting from operation day until last visit. The secondary objectives are to evaluate: * the performance of the dressing * the comfort, conformability and the acceptability of the dressing * pain before and during dressing removal on the last visit
Detailed description
A prospective, randomized clinical investigation will be conducted at two to three sites in Belgium and Sweden. Male or female, 18 years and older undergoing primary hip or knee arthroplasty with an expected hospital stay of 4 days or longer will be included in to the clinical investigation. 100 evaluable patients (i.e. 50 subjects per arm). The treatment arm (either Mepilex Border Post-Op or Aquacel Surgical) Patient eligibility will be established before treatment randomization. Patients will be randomized using optimal allocation (minimization) balancing for the following baseline variables type of surgery (hip or knee), age and skin status. Eligible patients will be randomized to receive Mepilex Border Post-Op or Aquacel surgical in a ratio of 1:1 provided.
Interventions
DEVICEActive Comparator: Aquacel Surgical
Post-operative all-in-one self-adherent soft silicone coated foam dressing. Duration of treatment: Total 5 days included the day of surgery and 4 post-operative days.
DEVICEExperimental: Mepilex Border Post-Op
Aquacel Surgical is a sterile, one piece post-operative dressing.Duration of treatment: Total 5 days included the day of surgery and 4 post-operative days.
Sponsors
Molnlycke Health Care AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
, enrolment phase 1. Age ≥ 18 years 2. Have an expected total length of stay of 4 postoperative days or more 3. Plan for elective primary arthroplasty of the hip or knee 4. Plan for incision size \> 18 cm 5. Give their written informed consent to participate Inclusion Criteria, randomization phase 1\. Undergoing elective primary arthroplasty of the hip or knee
Exclusion criteria
,enrolment phase 1. Known allergy or hypersensitivity to any of the components of the dressings 2. Multitrauma 3. Undergoing arthroplasty due to tumour 4. Wound at the surgical site prior to surgery 5. Neurological deficit of operated side ,hemiplegia, etc. 6. Documented skin disease at time of enrolment, as judged by the investigator 7. Previously enrolled in the present investigation 8. Included in another ongoing investigation at present which can interfere with the result of the dressing, judged by the investigator 9. Involvement in the planning and conduct of the clinical investigation, applies to all Molnlycke Health Care staff, investigational site staff and third party vendor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Variable Ranging From 0 to 7, Combining Complications (Dressing Failure) Related Surgical Wound, Computed as: 3*(Dressing Change) + 2*Blister + (Pain>=30mm) + Redness on the Skin Under the Dressing | 0-5 days | Scale range from 0 (no dressing failure) to 7 ( complete dressing failure). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Itching Feeling Under the Dressing | 0-5 days | Itching feeling under the dressing? Yes/No |
| Patients Satisfaction With Wearing the Dressing | 0-5 days | 4 point rating scale ( poor, good, very good,excellent) |
| Nurses/Doctors Satisfaction With Applying the Dressing | 0-5 days | 4 point rating scale ( poor, good, very good,excellent) |
| Dressings Adherence to the Staples/Sutures | 0-5 days | Dressings adherence to the staples/sutures? Yes/No |
| Local/Systemic Infection | 0-5 days | Local/systemic infection? Yes/No |
| Pain Level Before and During Dressing Removal | Day 7 | Different adhesive on the dressings, can any difference be identified during dressing removal. Pain level before dressing removal and pain level during dressing removal. Only measured on the last visit, with this point, the patient has not so much pain from the hip/knee joint replacement, which can have an effect on the result of dressing removal pain VAS scale (0-100 mm) 0= No pain, 100= Moste intense pain imainable. |
| Patients Mobility After Operation | 0-5 days | 4 point rating scale ( poor, good, very good,excellent) |
Countries
Belgium, Sweden
Participant flow
Recruitment details
118 subjects were enrolled and 113 subjects were randomized, Out of the 113 randomized subjects. Screening failure, IP never applied, inclusion criteria inclusion criteria 4 not met.=5 Not included in the analysis The patient signed IC after data been entered into the eCRF. Excluded from the analysis=5
Participants by arm
| Arm | Count |
|---|---|
| Device Mepilex Border Post-Op Post-operative all-in-one self-adherent soft silicone coated foam dressing.
Active Comparator: Aquacel Surgical: Post-operative all-in-one self-adherent soft silicone coated foam dressing | 53 |
| Device Aquacel Surgical Aquacel Surgical is a sterile, one piece post-operative dressing from ConvaTec.
Experimental: Mepilex Border Post-Op: Aquacel Surgical is a sterile, one piece post-operative dressing | 50 |
| Total | 103 |
Baseline characteristics
| Characteristic | Device Mepilex Border Post-Op | Device Aquacel Surgical | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 38 Participants | 34 Participants | 72 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 16 Participants | 31 Participants |
| Sex: Female, Male Female | 36 Participants | 27 Participants | 63 Participants |
| Sex: Female, Male Male | 17 Participants | 23 Participants | 40 Participants |
| Skin type Dry | 5 participants | 4 participants | 9 participants |
| Skin type Normal | 45 participants | 41 participants | 86 participants |
| Skin type Oily | 3 participants | 5 participants | 8 participants |
| Type of surgery Hip | 26 participants | 25 participants | 51 participants |
| Type of surgery Knee | 27 participants | 25 participants | 52 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 22 / 53 | 15 / 50 |
| serious Total, serious adverse events | 0 / 53 | 0 / 50 |
Outcome results
Primary
Composite Variable Ranging From 0 to 7, Combining Complications (Dressing Failure) Related Surgical Wound, Computed as: 3*(Dressing Change) + 2*Blister + (Pain>=30mm) + Redness on the Skin Under the Dressing
Scale range from 0 (no dressing failure) to 7 ( complete dressing failure).
Time frame: 0-5 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Device Mepilex Border Post-Op | Composite Variable Ranging From 0 to 7, Combining Complications (Dressing Failure) Related Surgical Wound, Computed as: 3*(Dressing Change) + 2*Blister + (Pain>=30mm) + Redness on the Skin Under the Dressing | Composite score 0 | 36 participants |
| Device Mepilex Border Post-Op | Composite Variable Ranging From 0 to 7, Combining Complications (Dressing Failure) Related Surgical Wound, Computed as: 3*(Dressing Change) + 2*Blister + (Pain>=30mm) + Redness on the Skin Under the Dressing | Composite score1 | 10 participants |
| Device Mepilex Border Post-Op | Composite Variable Ranging From 0 to 7, Combining Complications (Dressing Failure) Related Surgical Wound, Computed as: 3*(Dressing Change) + 2*Blister + (Pain>=30mm) + Redness on the Skin Under the Dressing | Composite score 2 | 0 participants |
| Device Mepilex Border Post-Op | Composite Variable Ranging From 0 to 7, Combining Complications (Dressing Failure) Related Surgical Wound, Computed as: 3*(Dressing Change) + 2*Blister + (Pain>=30mm) + Redness on the Skin Under the Dressing | Composite score 3 | 4 participants |
| Device Mepilex Border Post-Op | Composite Variable Ranging From 0 to 7, Combining Complications (Dressing Failure) Related Surgical Wound, Computed as: 3*(Dressing Change) + 2*Blister + (Pain>=30mm) + Redness on the Skin Under the Dressing | Composite score 4 | 3 participants |
| Device Mepilex Border Post-Op | Composite Variable Ranging From 0 to 7, Combining Complications (Dressing Failure) Related Surgical Wound, Computed as: 3*(Dressing Change) + 2*Blister + (Pain>=30mm) + Redness on the Skin Under the Dressing | Composite score 5 | 0 participants |
| Device Aquacel Surgical | Composite Variable Ranging From 0 to 7, Combining Complications (Dressing Failure) Related Surgical Wound, Computed as: 3*(Dressing Change) + 2*Blister + (Pain>=30mm) + Redness on the Skin Under the Dressing | Composite score 2 | 1 participants |
| Device Aquacel Surgical | Composite Variable Ranging From 0 to 7, Combining Complications (Dressing Failure) Related Surgical Wound, Computed as: 3*(Dressing Change) + 2*Blister + (Pain>=30mm) + Redness on the Skin Under the Dressing | Composite score 0 | 32 participants |
| Device Aquacel Surgical | Composite Variable Ranging From 0 to 7, Combining Complications (Dressing Failure) Related Surgical Wound, Computed as: 3*(Dressing Change) + 2*Blister + (Pain>=30mm) + Redness on the Skin Under the Dressing | Composite score 4 | 1 participants |
| Device Aquacel Surgical | Composite Variable Ranging From 0 to 7, Combining Complications (Dressing Failure) Related Surgical Wound, Computed as: 3*(Dressing Change) + 2*Blister + (Pain>=30mm) + Redness on the Skin Under the Dressing | Composite score 5 | 1 participants |
| Device Aquacel Surgical | Composite Variable Ranging From 0 to 7, Combining Complications (Dressing Failure) Related Surgical Wound, Computed as: 3*(Dressing Change) + 2*Blister + (Pain>=30mm) + Redness on the Skin Under the Dressing | Composite score1 | 11 participants |
| Device Aquacel Surgical | Composite Variable Ranging From 0 to 7, Combining Complications (Dressing Failure) Related Surgical Wound, Computed as: 3*(Dressing Change) + 2*Blister + (Pain>=30mm) + Redness on the Skin Under the Dressing | Composite score 3 | 4 participants |
Secondary
Dressings Adherence to the Staples/Sutures
Dressings adherence to the staples/sutures? Yes/No
Time frame: 0-5 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Device Mepilex Border Post-Op | Dressings Adherence to the Staples/Sutures | No | 53 participants |
| Device Mepilex Border Post-Op | Dressings Adherence to the Staples/Sutures | Yes | 0 participants |
| Device Aquacel Surgical | Dressings Adherence to the Staples/Sutures | No | 50 participants |
| Device Aquacel Surgical | Dressings Adherence to the Staples/Sutures | Yes | 0 participants |
Secondary
Itching Feeling Under the Dressing
Itching feeling under the dressing? Yes/No
Time frame: 0-5 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Device Mepilex Border Post-Op | Itching Feeling Under the Dressing | No | 53 participants |
| Device Mepilex Border Post-Op | Itching Feeling Under the Dressing | Yes | 0 participants |
| Device Aquacel Surgical | Itching Feeling Under the Dressing | No | 48 participants |
| Device Aquacel Surgical | Itching Feeling Under the Dressing | Yes | 2 participants |
Secondary
Local/Systemic Infection
Local/systemic infection? Yes/No
Time frame: 0-5 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Device Mepilex Border Post-Op | Local/Systemic Infection | No | 53 participants |
| Device Mepilex Border Post-Op | Local/Systemic Infection | Yes | 0 participants |
| Device Aquacel Surgical | Local/Systemic Infection | No | 50 participants |
| Device Aquacel Surgical | Local/Systemic Infection | Yes | 0 participants |
Secondary
Nurses/Doctors Satisfaction With Applying the Dressing
4 point rating scale ( poor, good, very good,excellent)
Time frame: 0-5 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Device Mepilex Border Post-Op | Nurses/Doctors Satisfaction With Applying the Dressing | Poor | 2 participants |
| Device Mepilex Border Post-Op | Nurses/Doctors Satisfaction With Applying the Dressing | Very Good | 17 participants |
| Device Mepilex Border Post-Op | Nurses/Doctors Satisfaction With Applying the Dressing | Good | 13 participants |
| Device Mepilex Border Post-Op | Nurses/Doctors Satisfaction With Applying the Dressing | Excellent | 21 participants |
| Device Aquacel Surgical | Nurses/Doctors Satisfaction With Applying the Dressing | Good | 35 participants |
| Device Aquacel Surgical | Nurses/Doctors Satisfaction With Applying the Dressing | Poor | 2 participants |
| Device Aquacel Surgical | Nurses/Doctors Satisfaction With Applying the Dressing | Excellent | 1 participants |
| Device Aquacel Surgical | Nurses/Doctors Satisfaction With Applying the Dressing | Very Good | 12 participants |
Secondary
Pain Level Before and During Dressing Removal
Different adhesive on the dressings, can any difference be identified during dressing removal. Pain level before dressing removal and pain level during dressing removal. Only measured on the last visit, with this point, the patient has not so much pain from the hip/knee joint replacement, which can have an effect on the result of dressing removal pain VAS scale (0-100 mm) 0= No pain, 100= Moste intense pain imainable.
Time frame: Day 7
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device Mepilex Border Post-Op | Pain Level Before and During Dressing Removal | Pain during removal of dressing at last visit | 6.9 units on a scale | Standard Deviation 11.7 |
| Device Mepilex Border Post-Op | Pain Level Before and During Dressing Removal | Pain before removal of dressing at last visit | 7.8 units on a scale | Standard Deviation 13.8 |
| Device Aquacel Surgical | Pain Level Before and During Dressing Removal | Pain before removal of dressing at last visit | 4.9 units on a scale | Standard Deviation 6.3 |
| Device Aquacel Surgical | Pain Level Before and During Dressing Removal | Pain during removal of dressing at last visit | 10 units on a scale | Standard Deviation 12 |
Secondary
Patients Mobility After Operation
4 point rating scale ( poor, good, very good,excellent)
Time frame: 0-5 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Device Mepilex Border Post-Op | Patients Mobility After Operation | Excellent | 18 participants |
| Device Mepilex Border Post-Op | Patients Mobility After Operation | Good | 12 participants |
| Device Mepilex Border Post-Op | Patients Mobility After Operation | Very good | 23 participants |
| Device Mepilex Border Post-Op | Patients Mobility After Operation | Poor | 0 participants |
| Device Aquacel Surgical | Patients Mobility After Operation | Excellent | 6 participants |
| Device Aquacel Surgical | Patients Mobility After Operation | Poor | 1 participants |
| Device Aquacel Surgical | Patients Mobility After Operation | Very good | 24 participants |
| Device Aquacel Surgical | Patients Mobility After Operation | Good | 19 participants |
Secondary
Patients Satisfaction With Wearing the Dressing
4 point rating scale ( poor, good, very good,excellent)
Time frame: 0-5 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Device Mepilex Border Post-Op | Patients Satisfaction With Wearing the Dressing | Poor | 0 participants |
| Device Mepilex Border Post-Op | Patients Satisfaction With Wearing the Dressing | Good | 13 participants |
| Device Mepilex Border Post-Op | Patients Satisfaction With Wearing the Dressing | Very good | 22 participants |
| Device Mepilex Border Post-Op | Patients Satisfaction With Wearing the Dressing | Excellent | 18 participants |
| Device Aquacel Surgical | Patients Satisfaction With Wearing the Dressing | Excellent | 6 participants |
| Device Aquacel Surgical | Patients Satisfaction With Wearing the Dressing | Poor | 1 participants |
| Device Aquacel Surgical | Patients Satisfaction With Wearing the Dressing | Very good | 24 participants |
| Device Aquacel Surgical | Patients Satisfaction With Wearing the Dressing | Good | 19 participants |