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

University of Witten/Herdecke

Status: Terminated

Conditions: Postoperative Abdominal Wounds; Wound-healing Impairments

Treatments: Device: Negative Pressure Wound Therapy; Other: Standard Wound Therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01611207

03-2012

DRKS ID 00003498 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to determine whether Negative Pressure Wound Therapy (NPWT) or Standard Conventional Wound Therapy (SCWT) are effective in the treatment of Iatrogenic Subcutaneous Abdominal Wound healing-impairments (ISAW).

Full description

The aim of the study is the comparison between NPWT and Standard Conventional Wound Therapy (SCWT) under clinical, safety and economic aspects in the treatment of postoperative Iatrogenic Subcutaneous Abdominal Wounds (ISAW). The hypothesis is based on the assumption that the application of NPWT for the treatment of postoperative abdominal wound healing impairments (with intact fascia) results in a decrease of time until achievement of wound closure (with confirmation after 30 consecutive days) and for this reason more wound closures can be achieved in the maximum treatment period of 42 days compared to the control therapy.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute subcutaneous abdominal wound-healing impairment after surgical intervention
• Sizes of wound opening (maximum diameter ≥ 3 cm)
• Wound surface ≥ 9 qcm

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 / during 3 weeks after chemo therapy
• Ongoing / during 3 weeks after radiation therapy Contraindications in accordance with the safety precautions issued by the FDA or the companies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Negative Pressure Wound Therapy

Experimental group

Description:

Used therapy systems

Treatment:

Device: Negative Pressure Wound Therapy

Standard Conventional Wound Therapy

Active Comparator group

Description:

Standard conventional wound therapy according to current evidence-based guideline (basic and advanced methods of wound treatment)

Treatment:

Other: Standard Wound Therapy