Prospective, Randomized Clinical Investigation of Two Different Postoperative Wound Dressings

Study Overview
=================
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.

Official Title
-----------------
A Prospective, Randomized, Controlled Clinical Investigation, Comparing Two Postoperative Wound Dressings Used After Elective Hip and Knee Replacement

Conditions
-----------------
Hip Surgery Corrective, Knee Injuries

Intervention / Treatment
-----------------
* Device: Active Comparator: Aquacel Surgical
* Device: Experimental: Mepilex Border Post-Op


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria, enrolment phase Age ≥ 18 years Have an expected total length of stay of 4 postoperative days or more Plan for elective primary arthroplasty of the hip or knee Plan for incision size > 18 cm 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 Known allergy or hypersensitivity to any of the components of the dressings Multitrauma Undergoing arthroplasty due to tumour Wound at the surgical site prior to surgery Neurological deficit of operated side ,hemiplegia, etc. Documented skin disease at time of enrolment, as judged by the investigator Previously enrolled in the present investigation Included in another ongoing investigation at present which can interfere with the result of the dressing, judged by the investigator Involvement in the planning and conduct of the clinical investigation, applies to all Molnlycke Health Care staff, investigational site staff and third party vendor. Exclusion Criteria, randomization phase Dressing size does not fit the incision area, over 18 cm Complications that would increase wound risks if investigation dressing is applied Postoperative drain

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Device Aquacel Surgical<br>Aquacel Surgical is a sterile, one piece post-operative dressing from Convatec. Duration of treatment: Total 5 days included the day of surgery and 4 post-operative days. | Device: Experimental: Mepilex Border Post-Op<br>* 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.<br>|
| Experimental: Device Mepilex Border Post-Op<br>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. | Device: Active Comparator: Aquacel Surgical<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 0-5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dressings Adherence to the Staples/Sutures | Dressings adherence to the staples/sutures? Yes/No | 0-5 days | 
| Itching Feeling Under the Dressing | Itching feeling under the dressing? Yes/No | 0-5 days | 
| Patients Satisfaction With Wearing the Dressing | 4 point rating scale ( poor, good, very good,excellent) | 0-5 days | 
| Nurses/Doctors Satisfaction With Applying the Dressing | 4 point rating scale ( poor, good, very good,excellent) | 0-5 days | 
| Patients Mobility After Operation | 4 point rating scale ( poor, good, very good,excellent) | 0-5 days | 
| Local/Systemic Infection | Local/systemic infection? Yes/No | 0-5 days | 
| 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. | Day 7 |