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

NCT01611207 | Terminated DMC

• 2 other identifiers: 03-2012DRKS ID 00003498
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 34

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).

Conditions

Postoperative Abdominal Wounds; Wound-healing Impairments

Keywords

wound healing impairments,; negative pressure wound therapy,; health services research,; germany

Outcome Measures

Primary Outcomes (1)

• 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.

  within 42 days of treatment

Secondary Outcomes (9)

• Wound volume

  within the observation period of 180 days

• Wound infections

  within the observation period of 180 days

• Recurrences

  wthin observation period of 180 days

• Pain

  within a maximum treatment time of 42 days

• Quality of Life

  within observation period of 180 days

Study Arms (2)

Negative Pressure Wound Therapy

EXPERIMENTAL

Used therapy systems

Device: Negative Pressure Wound Therapy

Standard Conventional Wound Therapy

ACTIVE COMPARATOR

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

Other: Standard Wound Therapy

Interventions

Negative Pressure Wound Therapy 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.

Also known as: Vacuum assisted closure, Vacuum assisted wound closure

Negative Pressure Wound Therapy

Standard Wound Therapy OTHER

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

Also known as: Standard Conventional Wound Therapy

Standard Conventional Wound Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Witten/Herdecke: lead
• Kinetic Concepts, Inc.: collaborator
• Smith & Nephew Wound Management Inc: collaborator

Study Sites (34)

Krankenhaus Martha-Maria Halle-Dölau

Halle, Saxony-Anhalt, 06120, Germany

Location

St. Marien-Krankenhaus Ahaus-Vrede

Ahaus, 48683, Germany

Location

Asklepios Stadtklinik Bad Tölz GmbH

Bad Tölz, 83646, Germany

Location

Bundeswehrkrankenhaus Berlin

Berlin, 10115, Germany

Location

Klinikum Bilefeld - Mitte

Bielefeld, 33604, Germany

Location

Knappschaftskrankenhaus Bochum der Ruhr

Bochum, 44892, Germany

Location

Klinikum Darmstadt, Chirurgische Klinik III

Darmstadt, 64283, Germany

Location

Diakonissenkrankenhaus Dessau /Roßlau

Dessau, 06846, Germany

Location

Krankenhaus Düren gem. GmbH

Düren, 52351, Germany

Location

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

Frankfurt am Main, 81377, Germany

Location

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

Halle, 06110, Germany

Location

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

Halle, 06120, Germany

Location

Asklepios Westklinikum Hamburg

Hamburg, 22559, Germany

Location

Sana Klinikum Hameln-Pyrmont Klinik für Allgemein- und Visceralchirurgie

Hamelin, 31785, Germany

Location

Gemeinschaftskrankenhaus Herdecke

Herdecke, 58313, Germany

Location

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

Jena, 07743, Germany

Location

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

Jena, 07743, Germany

Location

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

Kaiserslautern, 67655, Germany

Location

Städtisches Klinikum Karlsruhe gGmbH, Klinik für Allgemein- und Viszeralchirurgie

Karlsruhe, 76133, Germany

Location

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

Köln-Merheim, 51109, Germany

Location

Universitätsklinikum Schleswig-Holstein, Klinik für Chirurgie

Lübeck, 23538, Germany

Location

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

Mainz, 55131, Germany

Location

Wundzentrum München

München, 81927, Germany

Location

Klinikum der Universität München, Chirurgische Klinik und Poliklinik

München-Großhadern, 81377, Germany

Location

Universitätsklinikum Münster, Klinik für Allgemein und Viszeralchirurgie

Münster, 48149, Germany

Location

Städtisches Klinikum Neunkirchen

Neunkirchen/Saar, 66538, Germany

Location

Ortenauklinikum Offenburg-Gengenbach

Offenburg, 77654, Germany

Location

Klinikum Dorothea Christiane Erxleben

Quedlinburg, Germany

Location

Carl-von-Basedow Klinikum, Saalekreis

Querfurt, 06268, Germany

Location

Zentrum für Gefäßmedizin Klinikum Südstadt Rostock

Rostock, 18059, Germany

Location

Asklepios Klinikum Uckermark GmbH, Klinik für Allgemein- und Visceralchirurgie

Schwedt, 16303, Germany

Location

Agaplesion Bethesda-Krankenhaus Stuttgart

Stuttgart, 70184, Germany

Location

HSK Dr. Horst Schmidt Kliniken

Wiesbaden, 65195, Germany

Location

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

Wittenberg, 06886, Germany

Location

MeSH Terms

Interventions

Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Administative and scientific head of staffed offices of Interdisciplinary Centre for Health Services Research

Study Record Dates

• First Submitted: March 28, 2012
• First Posted: June 4, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: May 20, 2013

Record last verified: 2013-05

Locations

DE (34)