Effect of postoperative negative pressure wound therapy (Prevena TM) in clean closed surgical incisions on the incidence of wound dehiscence in low and high risk patients: a rondomized controlled pilotstudy.

Completed

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

• Registration Number: NL-OMON42830
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

* age 18 years or older
* signed informed consent form
* able to understand the Dutch language
* able to understand procedures and instructions
* no risk factor for wound dehiscence
* OR
* at least one risk factor for wound dehiscence:
- Diabetes Mellitus (DM)
- Body mass index >= 30
- active smoker (active and smoker in history)
- radiotherapy (Active and in history)
- COPD chronic obstructive pulmonary disease;AND patients undergoing one of the following elective sugical procedures:
o plastic surgery breastrecontruction through a abdominal transverse incision (DIEP flap or a typelike esthetical breastrecontruction)
o pressure ulcer surgery: for example rotation lap (skin and/or muscle fascia)
o VY-plasty technique
o TFL-flap (tensor fascia lata)

Exclusion Criteria

incompetence
fistulas in the area of the incision

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>wound dehiscence<br /><br>woundinfection (Surgucal Site Infection) </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>pain (on wound dressing)<br /><br>skin tension pre operative and postoperative</p><br>