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

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 - ISAW

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00003498

Enrollment

251

Registered

2012-01-27

Start date

2012-07-15

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iatrogenic subcutaneous abdominal wound healing disorder S31.1 T89.03

Interventions

Group 1: Intervention group: Negative Pressure Wound Therapy (NPWT) Group 2: Control group: Standard Conventional Wound Therapy (SCWT). Methods of simple and advanced wound treatment according to the

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)	—

Measure

Time frame

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)

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Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026