Treatment of Iatrogenic Subcutaneous Abdominal Wounds (ISAW) after surgery

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN44577192

Enrollment

250

Registered

2012-04-04

Start date

2012-02-15

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Iatrogenic Subcutaneous Abdominal Wounds Injury, Occupational Diseases, Poisoning

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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
1. Reduction of wound volume in the course of treatment (over time) 2. Wound infections 3. Relapses 4. Pain 5. Quality of Live 6. Patient-related endpoints / Patient Reported Outcome (PRO) 7. Consumption of resources in inpatient and outpatient setting and costs (economically orientated outcome parameters) 8. Stratification according to wound volume and study centre	—

Countries

Germany

Outcome results

None listed

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