Prospective, Randomized Clinical Investigation of Two Different Postoperative Wound Dressings

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

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

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.

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.

Exclusion Criteria, randomization phase

1. Dressing size does not fit the incision area, over 18 cm
2. Complications that would increase wound risks if investigation dressing is applied
3. Postoperative drain