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

NCT ID: NCT01611207

Last Updated: 2013-05-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2014-06-30

Brief Summary

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).

Detailed 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.

Conditions

Postoperative Abdominal Wounds; Wound-healing Impairments

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Negative Pressure Wound Therapy

Used therapy systems

Group Type: EXPERIMENTAL

Negative Pressure Wound Therapy

Intervention Type: DEVICE

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 Conventional Wound Therapy

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

Group Type: ACTIVE_COMPARATOR

Standard Wound Therapy

Intervention Type: OTHER

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

Interventions

Negative Pressure Wound Therapy

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.

Intervention Type: DEVICE

Standard Wound Therapy

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

Intervention Type: OTHER

Other Intervention Names

Vacuum assisted closure; Vacuum assisted wound closure; Standard Conventional Wound Therapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kinetic Concepts, Inc.

INDUSTRY

Sponsor Role: collaborator

Smith & Nephew Wound Management Inc

INDUSTRY

Sponsor Role: collaborator

University of Witten/Herdecke

OTHER

Sponsor Role: lead

Responsible Party

Dr. Marcus Redaèlli

Administative and scientific head of staffed offices of Interdisciplinary Centre for Health Services Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Bochum, , Germany

Klinikum Darmstadt, Chirurgische Klinik III

Darmstadt, , Germany

Diakonissenkrankenhaus Dessau /Roßlau

Dessau, , Germany

Krankenhaus Düren gem. GmbH

Düren, , Germany

Klinik für Gefäß- und Endovascular-Chirurgie, Klinikum der Johann Wolfgang Goethe - Universität

Frankfurt am Main, , Germany

Krankenhaus St. Elisabeth und St. Barbara, Klinik für Allgmein- und Visceralchirurgie

Halle, , Germany

Universitätsklinikum Halle/Saale, Allgemein-, Viszeral- und Gefäßchirurgie

Halle, , Germany

Asklepios Westklinikum Hamburg

Hamburg, , Germany

Sana Klinikum Hameln-Pyrmont Klinik für Allgemein- und Visceralchirurgie

Hamelin, , Germany

Gemeinschaftskrankenhaus Herdecke

Herdecke, , Germany

Universitätsklinikum Jena, Klinik für Allgemein-, Viszeral- und Gefäßchirurgie

Jena, , Germany

Universitätsklinikum Jena, Klinik für Frauenheilkunde und Geburtshilfe, Abt. Gynäkologie

Jena, , Germany

Westpfalz-Klinikum GmbH, Klinikum für Allgemein-, Viszeral- und Transplantationschirurgie

Kaiserslautern, , Germany

Städtisches Klinikum Karlsruhe gGmbH, Klinik für Allgemein- und Viszeralchirurgie

Karlsruhe, , Germany

Kliniken der Stadt Köln Krankenhaus Merheim, Klinik für Visceral-, Gefäß- und Transplantationschirurgie

Köln-Merheim, , Germany

Universitätsklinikum Schleswig-Holstein, Klinik für Chirurgie

Lübeck, , Germany

Klinik und Poliklinik für Allgemein- und Abdominalchirurgie, Johannes Gutenberg- Universität

Mainz, , Germany

Wundzentrum München

München, , Germany

Klinikum der Universität München, Chirurgische Klinik und Poliklinik

München-Großhadern, , Germany

Universitätsklinikum Münster, Klinik für Allgemein und Viszeralchirurgie

Münster, , Germany

Städtisches Klinikum Neunkirchen

Neunkirchen/Saar, , Germany

Ortenauklinikum Offenburg-Gengenbach

Offenburg, , Germany

Klinikum Dorothea Christiane Erxleben

Quedlinburg, , Germany

Carl-von-Basedow Klinikum, Saalekreis

Querfurt, , Germany

Zentrum für Gefäßmedizin Klinikum Südstadt Rostock

Rostock, , Germany

Asklepios Klinikum Uckermark GmbH, Klinik für Allgemein- und Visceralchirurgie

Schwedt, , Germany

Agaplesion Bethesda-Krankenhaus Stuttgart

Stuttgart, , Germany

HSK Dr. Horst Schmidt Kliniken

Wiesbaden, , Germany

Evangelisches Krankenhaus Paul Gerhardt Stift, Allgemein-, Viszeral- und Gefäßchirurgie

Wittenberg, , Germany

Countries

Germany

Other Identifiers

DRKS ID 00003498

Identifier Type: REGISTRY

Identifier Source: secondary_id

03-2012

Identifier Type: -

Identifier Source: org_study_id