Prospective, Randomized Clinical Investigation of Two Different Postoperative Wound Dressings

Not Applicable

Completed

• Conditions: Knee Injuries; Hip Surgery Corrective

• Registration Number: NCT02653183
• Lead Sponsor: Molnlycke Health Care AB

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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-11
• Study First Submitted QC: 2016-01-08
• Study First Posted: 2016-01-12
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Results First Submitted: 2016-10-20
• Status Verified: 2017-09
• Results First Submitted QC: 2019-04-03
• Last Update Submitted: 2019-04-03
• Results First Posted: 2019-07-01
• Last Update Posted: 2019-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Dressings Adherence to the Staples/Sutures	0-5 days	Dressings adherence to the staples/sutures? 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)
Itching Feeling Under the Dressing	0-5 days	Itching feeling under the dressing? Yes/No
Patients Mobility After Operation	0-5 days	4 point rating scale ( poor, good, very good,excellent)
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.

Trial Locations

Locations (3)

Södersjukhuset; 🇸🇪 Stockholm, Sweden

University Hospital Gent, Belgium; 🇧🇪 Gent, Belgium

Medisch Centrum Latem; 🇧🇪 Sint-Martens-Latem, Belgium