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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
118
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.
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.
University Hospital Gent, Belgium
Ghent, Belgium
Medisch Centrum Latem
Sint-Martens-Latem, Belgium
Södersjukhuset
Stockholm, Sweden
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
Dressings Adherence to the Staples/Sutures
Dressings adherence to the staples/sutures? Yes/No
Time frame: 0-5 days
Itching Feeling Under the Dressing
Itching feeling under the dressing? Yes/No
Time frame: 0-5 days
Patients Satisfaction With Wearing the Dressing
4 point rating scale ( poor, good, very good,excellent)
Time frame: 0-5 days
Nurses/Doctors Satisfaction With Applying the Dressing
4 point rating scale ( poor, good, very good,excellent)
Time frame: 0-5 days
Patients Mobility After Operation
4 point rating scale ( poor, good, very good,excellent)
Time frame: 0-5 days
Local/Systemic Infection
Local/systemic infection? Yes/No
Time frame: 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.
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Time frame: Day 7