Prospective, Randomized Study of 2 Different Wound Dressings

Hip-surgery Clinical Trial

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Official title:

A Mono-centre, Post CE-mark, Prospective-randomized Clinical Trial to Evaluate the Performance of a Flexible Self-adherent Absorbent Dressing Coated With a Soft Silicone Layer After Hip or Knee Arthroplasty or Primary Spine Surgery in Comparison to a Standard Wound Dressing (Cosmopor E®Steril, Fa. Hartmann)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01988818
• Other study ID #: Uni-Köln_2013-02
• Secondary ID: University Hospi
• Status: Completed
• Phase: N/A
• First received: November 13, 2013
• Last updated: May 10, 2016
• Start date: April 2014
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The primary objective of this investigation is to evaluate the performance of a self-adhesive absorbent post-operative dressing coated with a soft silicone layer in minimize the risk of the development of blistering in subjects after hip or knee arthroplasty or spinal surgery in comparison to a standard wound dressing The secondary objectives are to evaluate:

• the performance of the dressing

• the comfort, conformability and the acceptability of the dressing

• pain before, during and after dressing removal

• the overall cost regarding dressing wear time, time to do dressing change and personal resources needed

Description:

A monocentre, post CE-mark, randomized clinical trial will be conducted at the University of Cologne, Department of Orthopedics and Trauma Surgery.

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).

AEs/ADEs/unexpected events with the device may be documented by relevant photos at time. All photos shall include a sticker marked with subject code, visit number/date and time.

Outcome Measures

Primary variable:

• Development of blistering from day 0 to day 6 post surgery Photo documentation will be evaluated in a blinded manner by the Clinical Evaluation Committee (CEC).

Secondary variables:

• Other wound complications (i.e. leakage, inflammation, infection)

• Number of dressing changes

• Pain before, during and after dressing removal (VA scale)

• Performance and acceptability of the dressing (4 point rating scale)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age =18years

2. Have an expected total length of stay of 4 or more days

3. Undergoing elective primary arthroplasty of the hip or knee or spinal surgery

4. Undergoing hip surgery with a standard access

5. Give their written informed consent to participate

Exclusion Criteria:

1. Dressing size does not fit the incision area

2. Known allergy/hypersensitivity to any of the components of the dressing

3. Multi-trauma

4. Undergoing arthroplasty or spine surgery due to tumour or infection?

5. Fractures

6. Wound at the surgical site prior to surgery

7. Neurological deficit of operated side (hemiplegia, etc.)

8. Subject has documented skin disease at time of enrolment, as judged by the investigator

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hip-surgery
• Knee-surgery
• Spinal-surgery

Intervention

Device:
• Mepilex® Border Post-Op
wound dressing with Mepilex® Border Post-Op with Safetac®Technology, self-adherent soft silicone surgical dressing
• standard wound dressing
standard wound dressing after hip-knee or spinal surgery

Locations

Country	Name	City	State
Germany	University Hospital Cologne	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blistering	Development of blistering from day 0 to day 6 post surgery Photo documentation will be evaluated in a blinded manner by the Clinical Evaluation Committee (CEC).	0-6 days	Yes
Secondary	wound complications	Other wound complications (i.e. leakage, inflammation, infection)	0-6 days	Yes
Secondary	dressing changes	Number of dressing changes	0-6 days	No
Secondary	pain	Pain before, during and after dressing removal (VA scale)	0-6 days	No
Secondary	performance and acceptability	Performance and acceptability of the dressing (4 point rating scale)	0-6 days	No