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/Herdecke12 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Postoperative Abdominal Wounds Wound-healing Impairments

Interventions

Negative Pressure Wound TherapyDEVICE

KCI. V.A.C. Freedom; Acti V.A.C.; INFO V.A.C. to be used with the V.A.C. Granufoam (black), V.A.C. Granufoam Silver and V.A.C. WhiteFoam Smith \& Nephew: Renasys GO and Renasys EZ Plus to be used with the Renassys-F/P and Renassys-G Use of the medical devices and applicable consumption items according to manufacturers guidelines and FDA regulations.

Standard Wound TherapyOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (34)

Krankenhaus Martha-Maria Halle-Dölau

Halle, Saxony-Anhalt, Germany

St. Marien-Krankenhaus Ahaus-Vrede

Ahaus, Germany

Asklepios Stadtklinik Bad Tölz GmbH

Bad Tölz, Germany

Bundeswehrkrankenhaus Berlin

Berlin, Germany

Klinikum Bilefeld - Mitte

Bielefeld, Germany

Knappschaftskrankenhaus Bochum der Ruhr

Outcomes

Primary Outcomes

Wound closure

Time-of-closure (in days) achieved and confirmed wound closures and rate-of-closure (in number). The wound closure is defined as 100% epithelialization; no need for drainage, no need for supportive therapy or a means of assistance and absence of suture material. The closure must remain at least for a period of 30 days.

Time frame: within 42 days of treatment

Secondary Outcomes

Wound volume

Reduction of wound volume (cubic centimeter) in the course of treatment.

Time frame: within the observation period of 180 days

Wound infections

Number of wound infections over the time.

Time frame: within the observation period of 180 days

Recurrences

Number of recurrences over the time.

Time frame: wthin observation period of 180 days

Pain

Time frame: within a maximum treatment time of 42 days

Quality of Life

EQ-5D at inclusion, end of maximum treatment time or end of therapy, Follow-Up after 180 days.

Time frame: within observation period of 180 days

Direct costs

direct medical resource use and costs: hospitalization, outpatient contact with study centre and other providers, reimbursable drugs, medical sundries, adjuvants, reimbursable services direct non-medical resource use and costs: services, travel costs, expenditure of time for patients, expenditure of time for lay care

Time frame: within a maximum treatment time of 42 days or until end of therapy

Indirect costs

Disability, disability pension, premature death

Time frame: within a maximum treatment time of 42 days or until end of therapy

Serious adverse events

Time frame: within the observation period of 180 days

Adverse events

Wound- and device-specific adverse events

Time frame: within a maximum treatment time of 42 days