A Prospective, Randomized, Controlled Clinical Investigation, Comparing Two Postoperative Wound Dressings Used After Elective Hip and Knee Replacement
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hip Surgery Corrective
- Sponsor
- Molnlycke Health Care AB
- Enrollment
- 118
- Locations
- 3
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 6 years ago
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
Time Frame: 0-5 days
Scale range from 0 (no dressing failure) to 7 ( complete dressing failure).
Secondary Outcomes
- Dressings Adherence to the Staples/Sutures(0-5 days)
- Patients Satisfaction With Wearing the Dressing(0-5 days)
- Nurses/Doctors Satisfaction With Applying the Dressing(0-5 days)
- Itching Feeling Under the Dressing(0-5 days)
- Patients Mobility After Operation(0-5 days)
- Local/Systemic Infection(0-5 days)
- Pain Level Before and During Dressing Removal(Day 7)