NCT02653183

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Molnlycke Health Care AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hip Surgery Corrective
• Knee Injuries

Interventions

Type	Name	Description
DEVICE	Active Comparator: Aquacel Surgical	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	Experimental: Mepilex Border Post-Op	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.

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2016-01-12
• Last updated: 2019-07-01
• Results posted: 2019-07-01

Locations

3 sites across 2 countries: Belgium, Sweden