Post Market Clinical Follow-up Study

Phase 4

Completed

• Conditions: Hip or Knee Surgery
• Interventions: Device: Mepilex border post. op; Device: Mepilex border post op

• Registration Number: NCT01841567
• Lead Sponsor: Molnlycke Health Care AB

Brief Summary

The overall rationale for this study is to evaluate the clinical performance potential for Mepilex Border Post-Op in the ability to minimise the risk of blistering, maceration and less dressing change due to high absorption capacity. This study is a part of Post Market Clinical Follow-Up (PMCF).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-23
• Study First Submitted QC: 2013-04-25
• Study First Posted: 2013-04-26
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2013-12
• Results First Submitted: 2014-04-16
• Results First Submitted QC: 2014-09-26
• Last Update Submitted: 2014-09-26
• Results First Posted: 2014-09-30
• Last Update Posted: 2014-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dressing	Mepilex border post op	-
dressing	Mepilex border post. op	-

Primary Outcome Measures

Name	Time	Method
Minimize the Risk of the Development of Blistering.	7 days	Number of participants without blisters at study visit

Secondary Outcome Measures

Name	Time	Method
Pain Evaluation	7 days
Number of Participants Rated 'Very Good to Excellent' for Comfort, Conformability and the Acceptability of the Dressing.	7 days	The comfort, conformability and the acceptability of the dressing were measured on all visit in the study, by a study nurses. The patient had to answer questions regarding, the size of the dressing, shape of the dressing, Visibility beneath the dressing, ease of the application of the dressing, ease of removal of the dressing, overall experience of the use of the dressing, notice any pain at dressing change, Comfort of their dressing, overall experience of their dressing. The patient could chose between 1 Good, 2 Very good, 3 Excellent.In most cases, the patient chose very good to excellent for both hip and knee surgery
Comfort, Comformability, Acceptability of the Dressing	7 days
Overall Cost Regarding Dressing Wear Time	7 days

Trial Locations

Locations (1)

universitätsklinikum Köln; 🇩🇪 Köln, Germany