Treatment of subcutaneous abdominal wound healing impairment after surgery without fascial dehiscence by Vacuum-Assisted Closure® (V.A.C. ® SAWHI-Study) versus standard conventional wound therapy
Recruiting
- Conditions
- onderhuids abdominale wondhelingsstoornis zonder fasciedehiscentie na operatieNA10040795
- Registration Number
- NL-OMON35758
- Lead Sponsor
- niversity of Witten/Herdecke
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
There are 2 categories of Subjects with distinct post-surgical open abdominal wound diagnoses that will qualify for this study:
• Subjects with primarily closed post-surgical abdominal wounds without fascial dehiscence that develop a spontaneous wound dehiscence or require an active reopening of the wound by the attending physician;• Subjects with open post-surgical abdominal wounds without fascial dehiscence that cannot be closed by primary intention and require further treatment to achieve permanent closure
Exclusion Criteria
Pregnant;Dehiscence of the abdominal fascia ;Any pre-existing or ongoing organ system failure;Active signs or symptoms of Abdominal Compartment Syndrome
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of this multicenter, parallel design, prospective,<br /><br>randomized clinical trial is to compare the clinical safety and economic<br /><br>outcomes of VAC therapy and SCWT in postsurgical abdominal wound healing<br /><br>impairments without fascial dehiscence.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are related to a number of wound healing variables<br /><br>(re-opened wound, wound size reduction), safety and quality of life.</p><br>