Treatment of Iatrogenic Subcutaneous Abdominal Wounds (ISAW) after surgery
Not Applicable
Completed
- Conditions
- Iatrogenic Subcutaneous Abdominal WoundsInjury, Occupational Diseases, Poisoning
- Registration Number
- ISRCTN44577192
- Lead Sponsor
- niversity Witten/Herdecke (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 250
Inclusion Criteria
1. Acute subcutaneous abdominal wound-healing impairment after surgical intervention
2. Sizes of wound opening (maximum diameter = 3 cm)
3. Wound depth = 3 cm
4. Wound surface = 9 cm2
Exclusion Criteria
1. Lack of infrastructure for outpatient continuation of treatment and study-specific interventions
2. Existence of an open abdominal fascia
3. Acute serious organ failure
4. Application of an other active vacuum device at the wound treated during the study conduct within 8 days before screening visit
5. Ongoing/during 3 weeks after chemo therapy
6. Ongoing/during 3 weeks after radiation therapy
7. Contraindications in accordance with the safety precautions issued by the FDA or the companies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Time (number of days) to the achievement of complete wound closure (Time-to-Closure) within 42 days of treatment<br>2. Number of achieved wound closures within maximum therapy period (Rate-of-Closure) within 42 days of treatment
- Secondary Outcome Measures
Name Time Method 1. Reduction of wound volume in the course of treatment (over time)<br>2. Wound infections<br>3. Relapses<br>4. Pain<br>5. Quality of Live<br>6. Patient-related endpoints / Patient Reported Outcome (PRO)<br>7. Consumption of resources in inpatient and outpatient setting and costs (economically orientated outcome parameters)<br>8. Stratification according to wound volume and study centre