Performance of Flexible Self-adherent Absorbent Dressing Coated With a Soft Silicone Layer After Hip -,Knee- Arthroplasty,Primary Spine Surgery in Comparison to a Standard Wound Dressing

NCT02771015 | Completed

• 1 other identifier: Uni-Köln_2013-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Male or female subjects, 18 years and above, undergoing hip, knee or spinal surgery with an expected hospital stay for 4 days or more will be included in the trial. Individual trial duration will be for 7 days (follow-up). Two hundred subjects will be included in the trial, i.e. 100 subjects per arm. The treatment arm (either new or standard wound dressing) will be assigned by randomization stratified by type of surgery (i.e. hip, knee or spine).

Conditions

Hip-arthroplasty; Knee-arthroplasty; Spine Surgery

Outcome Measures

Primary Outcomes (1)

• Minimize the Risk of the Development of Blistering

  Number of participants without blisters at study visit

  7 days after surgery

Secondary Outcomes (4)

• Number of Participants Rated 'Very Good to Excellent' for Comfort, Conformability and the Acceptability of the Dressing

  7 days

• Comfort, Comformability, Acceptability of the Dressing

  7 days

• Change From Baseline in Pain on the visual analog scale

  7 days

• the overall cost regarding dressing wear time

  7 days

Study Arms (2)

Mepilex Border®

ACTIVE COMPARATOR

Mepilex Border® wound dressing at patients after hip-knee or primary spine surgery

Device: Mepilex Border®

Cosmopor steril®

ACTIVE COMPARATOR

Standard wound dressing at patients after hip-knee or primary spine surgery

Device: Cosmopor steril®

Interventions

Mepilex Border® DEVICE

randomization

Mepilex Border®

Cosmopor steril® DEVICE

randomization

Cosmopor steril®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18years
• Have an expected total length of stay of 4 or more days
• Undergoing elective primary arthroplasty of the hip or knee or spinal surgery
• Undergoing hip surgery with a standard access
• Give their written informed consent to participate

You may not qualify if:

• Dressing size does not fit the incision area
• Known allergy/hypersensitivity to any of the components of the dressing
• Multi-trauma
• Undergoing arthroplasty due to tumor
• Fractures
• Wound at the surgical site prior to surgery
• Neurological deficit of operated side (hemiplegia, etc.)
• Subject has documented skin disease at time of enrolment, as judged by the investigator

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

University Hospital Cologne

Cologne, North Rhine-Westphalia, 50931, Germany

Location

Study Officials

• Jan Bredow

  University Hospital Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.med.

Study Record Dates

• First Submitted: September 8, 2015
• First Posted: May 12, 2016
• Study Start: August 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: May 1, 2016
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

DE (1)