Comparing Negative Pressure Wound Therapy with Instillation vs. Standard wound care to treat postoperative wound infections.
- Conditions
- inflammationwound infection10040795
- Registration Number
- NL-OMON54383
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 446
In order to participate in this study, a subject must meet all of the following
criteria:
• Age equal or older than 18 years;
• A superficial or deep SSI plus a wound dehiscence (> 5 cm dehiscence) or a
wound that needs to be opened for drainage of SSI after any type of surgery;
• SSI occurring within 30 days after surgery;
• A minimum wound size of 10 cm² to allow proper application of the study
treatments;
• Written informed consent.
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• A deep organ/space SSI without a superficial (involvement of skin and fascia)
wound infection
• Psychically or mentally inability for informed consent
• Fascial dehiscence > 0,5 cm
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome: Time to complete wound healing defined as re-epithelization of<br /><br>the total wound surface or if the wound is ready for secondary surgical closure<br /><br>(i.e. healthy red granulation tissue without signs of infection or debris). </p><br>
- Secondary Outcome Measures
Name Time Method