Effect of a negative pressure dressing (Prevena TM) on the prevention of wound dehiscence in clean closed surgical incisions: a rondomized controlled trial.

Completed

• Conditions: Wound dehiscence; wound rupture; 10069888; 10040790; 10043413

• Registration Number: NL-OMON42308
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 450

Inclusion Criteria

* age 18 years or older
* signed informed consent form
* able to understand the Dutch language
* able to understand procedures and instructions
* at least one risk factor for wound dehiscence
- chronic obstructive pulmonary disease
- diabetes mellitus
- peripheral artery disease
- body mass index >= 30
- Active smoker
- Radiotherapy in history
- Earlier surgery in the same area
AND the patient undergoes one of the following elective sugical procedures:
o abdominal surgery through median laparotomy,
o vascular surgery through median laparotomy, upper leg and/or lower leg
o orthopedic surgery: hemipelvectomy, total knee replacement
o plastic surgery through a transverse suprapubic incision.

Exclusion Criteria

incompetence
open fracture
fistulas in the area of the incision
simultaneous participation in another study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>wounddehiscence</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>surgical site infection<br /><br>pain<br /><br>allergy for the wounddressing</p><br>