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

Authors
Category Primary study
Registry of TrialsGerman Clinical Trials Register
Year 2012
INTERVENTION: Intervention 1: Intervention group: Negative Pressure Wound Therapy (NPWT) Intervention 2: Control group: Standard Conventional Wound Therapy (SCWT). Methods of simple and advanced wound treatment according to the therapy recommendations. CONDITION: Iatrogenic subcutaneous abdominal wound healing disorder S31.1 ‐ Open wound of abdominal wall T89.03 ‐ PRIMARY OUTCOME: Controlled testing of two primary endpoints:; 1) Time (number of days) to the achievement of complete wound closure (Time‐to‐Closure) within 42 days of treatment; ; 2) Number of achieved wound closures within maximum therapy period (Rate‐of‐Closure) within 42 days of treatment SECONDARY OUTCOME: Secondary endpoints related to efficacy:; • Reduction of wound volume in the course of treatment (over time); • Wound infections; • Relapses; • Pain; • Quality of Live; ; Safety endpoints:; ; •; Therapeutic AE, Specific therapeutic SAE, Mortalitiy.; Health econonomic endpoints:; 1) Patient‐related endpoints / Patient Reported Outcome (PRO); 2) Consumption of resources in inpatient and outpatient setting and costs (economically orientated outcome parameters) 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
Epistemonikos ID: 826c359627820e2ee9d9715a4b87f26715524888
First added on: Aug 22, 2024