Randomised controlled study to evaluate the efficacy of the treatment of Iatrogenic Subcutaneous Abdominal Wounds (ISAW) after surgery by application of Negative Pressure Wound Therapy (NPWT) in comparison to Standard Conventional Wound Therapy (SCWT) of the clinical routine

Not Applicable

Conditions: Iatrogenic subcutaneous abdominal wound healing disorder
S31.1
T89.03
Open wound of abdominal wall

Registration Number: DRKS00003498

Lead Sponsor: Private Universität Witten/Herdecke gGmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting stopped after recruiting started

Sex: All

Target Recruitment: 12

Inclusion Criteria

Key inclusion criteria:
•Acute subcutaneous abdominal wound-healing impairment after surgical intervention
•Sizes of wound opening (maximum diameter = 3 cm)
•Wound depth = 3 cm
•Wound surface = 9 cm2

Exclusion Criteria

Key exclusion criteria:
•Lack of infrastructure for outpatient continuation of treatment and study-specific interventions
•Existence of an open abdominal fascia
•Acute serious organ failure
•Application of an other active vacuum device at the wound treated during the study conduct within 8 days before screening visit
•Ongoing chemotherapy / during 3 weeks after chemotherapy
•Ongoing radiation therapy / during 3 weeks after radiation therapy
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
Controlled testing of two primary endpoints:<br>1) Time (number of days) to the achievement of complete wound closure (Time-to-Closure) within 42 days of treatment<br><br>2) Number of achieved wound closures within maximum therapy period (Rate-of-Closure) within 42 days of treatment<br>

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints related to efficacy:<br>•Reduction of wound volume in the course of treatment (over time)<br>•Wound infections<br>•Relapses<br>•Pain<br>•Quality of Live<br><br>Safety endpoints:<br><br>•<br>Therapeutic AE, Specific therapeutic SAE, Mortalitiy.<br>Health econonomic endpoints:<br>1)Patient-related endpoints / Patient Reported Outcome (PRO)<br>2)Consumption of resources in inpatient and outpatient setting and costs (economically orientated outcome parameters)<br>