NCT03016078

Self-adherent Absorbent Silver Dressing in Adults After Hip or Knee Arthroplasty

A Single Center, Open, Non-controlled Investigation to Evaluate the Performance of a Flexible, Self-adherent Absorbent Silver Dressing Coated With a Soft Silicone Layer After Elective Primary Total Hip or Knee Arthroplasty

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Molnlycke Health Care AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall rationale for this investigation is to evaluate the clinical performance potential for Mepilex Border Post-Op Ag in the ability to minimize the risk of skin related post-operative wound complications such as blistering, maceration and redness at the incision and surrounding skin.

Detailed description

This was a descriptive, open, prospective, non-controlled clinical investigation conducted on 21 enrolled subjects at one site in the United states of America (USA). The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty with a possibility to participate in a follow-up visit 7 days after surgery. The primary purpose was to investigate if there was any skin damage under the dressing from operation day to last visit. Performance of the dressing as well as comfort, conformability, acceptability and pain at dressing removal was also followed-up until post-op day 7.

Conditions

• Arthroplasties, Hip Replacement
• Arthroplasties, Knee Replacement

Interventions

Type	Name	Description
DEVICE	Mepilex Border Post-Op Ag	To investigate if there was any skin damage under the dressing from operation day to last visit.

Timeline

• Start date: 2017-02-01
• Primary completion: 2017-04-01
• Completion: 2017-04-07
• First posted: 2017-01-10
• Last updated: 2018-02-14
• Results posted: 2018-02-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study