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 (ISAW)

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.

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).

Study Overview

• Status: Terminated
• Conditions: Postoperative Abdominal Wounds; Wound-healing Impairments
• Intervention / Treatment: Device: Negative Pressure Wound Therapy; Other: Standard Wound Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Ahaus, Germany, 48683
    • St. Marien-Krankenhaus Ahaus-Vrede
  • Bad Tölz, Germany, 83646
    • Asklepios Stadtklinik Bad Tölz GmbH
  • Berlin, Germany, 10115
    • Bundeswehrkrankenhaus Berlin
  • Bielefeld, Germany, 33604
    • Klinikum Bilefeld - Mitte
  • Bochum, Germany, 44892
    • Knappschaftskrankenhaus Bochum der Ruhr
  • Darmstadt, Germany, 64283
    • Klinikum Darmstadt, Chirurgische Klinik III
  • Dessau /Roßlau, Germany, 06846
    • Diakonissenkrankenhaus Dessau /Roßlau
  • Düren, Germany, 52351
    • Krankenhaus Düren gem. GmbH
  • Frankfurt am Main, Germany, 81377
    • Klinik für Gefäß- und Endovascular-Chirurgie, Klinikum der Johann Wolfgang Goethe - Universität
  • Halle (Saale), Germany, 06110
    • Krankenhaus St. Elisabeth und St. Barbara, Klinik für Allgmein- und Visceralchirurgie
  • Halle (Saale), Germany, 06120
    • Universitätsklinikum Halle/Saale, Allgemein-, Viszeral- und Gefäßchirurgie
  • Hamburg, Germany, 22559
    • Asklepios Westklinikum Hamburg
  • Hameln, Germany, 31785
    • Sana Klinikum Hameln-Pyrmont Klinik für Allgemein- und Visceralchirurgie
  • Herdecke, Germany, 58313
    • Gemeinschaftskrankenhaus Herdecke
  • Jena, Germany, 07743
    • Universitätsklinikum Jena, Klinik für Allgemein-, Viszeral- und Gefäßchirurgie
  • Jena, Germany, 07743
    • Universitätsklinikum Jena, Klinik für Frauenheilkunde und Geburtshilfe, Abt. Gynäkologie
  • Kaiserslautern, Germany, 67655
    • Westpfalz-Klinikum GmbH, Klinikum für Allgemein-, Viszeral- und Transplantationschirurgie
  • Karlsruhe, Germany, 76133
    • Städtisches Klinikum Karlsruhe gGmbH, Klinik für Allgemein- und Viszeralchirurgie
  • Köln-Merheim, Germany, 51109
    • Kliniken der Stadt Köln Krankenhaus Merheim, Klinik für Visceral-, Gefäß- und Transplantationschirurgie
  • Lübeck, Germany, 23538
    • Universitätsklinikum Schleswig-Holstein, Klinik für Chirurgie
  • Mainz, Germany, 55131
    • Klinik und Poliklinik für Allgemein- und Abdominalchirurgie, Johannes Gutenberg- Universität
  • München, Germany, 81927
    • Wundzentrum München
  • München-Großhadern, Germany, 81377
    • Klinikum der Universität München, Chirurgische Klinik und Poliklinik
  • Münster, Germany, 48149
    • Universitätsklinikum Münster, Klinik für Allgemein und Viszeralchirurgie
  • Neunkirchen/Saar, Germany, 66538
    • Städtisches Klinikum Neunkirchen
  • Offenburg, Germany, 77654
    • Ortenauklinikum Offenburg-Gengenbach
  • Quedlinburg, Germany
    • Klinikum Dorothea Christiane Erxleben
  • Querfurt, Germany, 06268
    • Carl-von-Basedow Klinikum, Saalekreis
  • Rostock, Germany, 18059
    • Zentrum für Gefäßmedizin Klinikum Südstadt Rostock
  • Schwedt, Germany, 16303
    • Asklepios Klinikum Uckermark GmbH, Klinik für Allgemein- und Visceralchirurgie
  • Stuttgart, Germany, 70184
    • Agaplesion Bethesda-Krankenhaus Stuttgart
  • Wiesbaden, Germany, 65195
    • HSK Dr. Horst Schmidt Kliniken
  • Wittenberg, Germany, 06886
    • Evangelisches Krankenhaus Paul Gerhardt Stift, Allgemein-, Viszeral- und Gefäßchirurgie
  • Sachsen-Anhalt
    • Halle (Saale), Sachsen-Anhalt, Germany, 06120
      • Krankenhaus Martha-Maria Halle-Dölau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Negative Pressure Wound Therapy; Used therapy systems	Device: 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.; Other Names: Vacuum assisted closure; Vacuum assisted wound closure
Active Comparator: Standard Conventional Wound Therapy; Standard conventional wound therapy according to current evidence-based guideline (basic and advanced methods of wound treatment)	Other: Standard Wound Therapy; Standard wound therapy according to current evidence-based guideline (basic and advanced methods of wound treatment); Other Names: Standard Conventional Wound Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound volume	Reduction of wound volume (cubic centimeter) in the course of treatment.	within the observation period of 180 days
Wound infections	Number of wound infections over the time.	within the observation period of 180 days
Recurrences	Number of recurrences over the time.	wthin observation period of 180 days
Pain		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.	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	within a maximum treatment time of 42 days or until end of therapy
Indirect costs	Disability, disability pension, premature death	within a maximum treatment time of 42 days or until end of therapy
Serious adverse events		within the observation period of 180 days
Adverse events	Wound- and device-specific adverse events	within a maximum treatment time of 42 days

Collaborators and Investigators

• Sponsor: University of Witten/Herdecke
• Collaborators: Kinetic Concepts, Inc.; Smith & Nephew Wound Management Inc

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): June 1, 2014

Study Registration Dates

• First Submitted: March 28, 2012
• First Submitted That Met QC Criteria: June 1, 2012
• First Posted (Estimate): June 4, 2012

Study Record Updates

• Last Update Posted (Estimate): May 20, 2013
• Last Update Submitted That Met QC Criteria: May 17, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: germany; wound healing impairments,; negative pressure wound therapy,; health services research,
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 03-2012; DRKS ID 00003498 (Registry Identifier: German Clinical Trials Register)