Clinical trial NCT01611207: 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
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Postoperative Abdominal Wounds
Wound-healing Impairments
Keywords: wound healing impairments,
negative pressure wound therapy,
health services research,
germany
Lead sponsor: University of Witten/Herdecke
Sponsor class: OTHER
Collaborators: name: Kinetic Concepts, Inc.
name: Smith & Nephew Wound Management Inc
First posted: 2012-06-04
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Wound closure
timeFrame: within 42 days of treatment
Secondary outcomes:
measure: Wound volume
timeFrame: within the observation period of 180 days
measure: Wound infections
timeFrame: within the observation period of 180 days
measure: Recurrences
timeFrame: wthin observation period of 180 days
measure: Pain
timeFrame: within a maximum treatment time of 42 days
measure: Quality of Life
timeFrame: within observation period of 180 days
measure: Direct costs
timeFrame: within a maximum treatment time of 42 days or until end of therapy
measure: Indirect costs
timeFrame: within a maximum treatment time of 42 days or until end of therapy
measure: Serious adverse events
timeFrame: within the observation period of 180 days
measure: Adverse events
timeFrame: within a maximum treatment time of 42 days
Other outcomes:
Locations:
city: Halle (Saale)
country: Germany
facility: Krankenhaus Martha-Maria Halle-Dölau
state: Sachsen-Anhalt
city: Ahaus
country: Germany
facility: St. Marien-Krankenhaus Ahaus-Vrede
city: Bad Tölz
country: Germany
facility: Asklepios Stadtklinik Bad Tölz GmbH
city: Berlin
country: Germany
facility: Bundeswehrkrankenhaus Berlin
city: Bielefeld
country: Germany
facility: Klinikum Bilefeld - Mitte
city: Bochum
country: Germany
facility: Knappschaftskrankenhaus Bochum der Ruhr
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt, Chirurgische Klinik III
city: Dessau /Roßlau
country: Germany
facility: Diakonissenkrankenhaus Dessau /Roßlau
city: Düren
country: Germany
facility: Krankenhaus Düren gem. GmbH
city: Frankfurt am Main
country: Germany
facility: Klinik für Gefäß- und Endovascular-Chirurgie, Klinikum der Johann Wolfgang Goethe - Universität
city: Halle (Saale)
country: Germany
facility: Krankenhaus St. Elisabeth und St. Barbara, Klinik für Allgmein- und Visceralchirurgie
city: Halle (Saale)
country: Germany
facility: Universitätsklinikum Halle/Saale, Allgemein-, Viszeral- und Gefäßchirurgie
city: Hamburg
country: Germany
facility: Asklepios Westklinikum Hamburg
city: Hameln
country: Germany
facility: Sana Klinikum Hameln-Pyrmont Klinik für Allgemein- und Visceralchirurgie
city: Herdecke
country: Germany
facility: Gemeinschaftskrankenhaus Herdecke
city: Jena
country: Germany
facility: Universitätsklinikum Jena, Klinik für Allgemein-, Viszeral- und Gefäßchirurgie
city: Jena
country: Germany
facility: Universitätsklinikum Jena, Klinik für Frauenheilkunde und Geburtshilfe, Abt. Gynäkologie
city: Kaiserslautern
country: Germany
facility: Westpfalz-Klinikum GmbH, Klinikum für Allgemein-, Viszeral- und Transplantationschirurgie
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum Karlsruhe gGmbH, Klinik für Allgemein- und Viszeralchirurgie
city: Köln-Merheim
country: Germany
facility: Kliniken der Stadt Köln Krankenhaus Merheim, Klinik für Visceral-, Gefäß- und Transplantationschirurgie
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Klinik für Chirurgie
city: Mainz
country: Germany
facility: Klinik und Poliklinik für Allgemein- und Abdominalchirurgie, Johannes Gutenberg- Universität
city: München-Großhadern
country: Germany
facility: Klinikum der Universität München, Chirurgische Klinik und Poliklinik
city: München
country: Germany
facility: Wundzentrum München
city: Münster
country: Germany
facility: Universitätsklinikum Münster, Klinik für Allgemein und Viszeralchirurgie
city: Neunkirchen/Saar
country: Germany
facility: Städtisches Klinikum Neunkirchen
city: Offenburg
country: Germany
facility: Ortenauklinikum Offenburg-Gengenbach
city: Quedlinburg
country: Germany
facility: Klinikum Dorothea Christiane Erxleben
city: Querfurt
country: Germany
facility: Carl-von-Basedow Klinikum, Saalekreis
city: Rostock
country: Germany
facility: Zentrum für Gefäßmedizin Klinikum Südstadt Rostock
city: Schwedt
country: Germany
facility: Asklepios Klinikum Uckermark GmbH, Klinik für Allgemein- und Visceralchirurgie
city: Stuttgart
country: Germany
facility: Agaplesion Bethesda-Krankenhaus Stuttgart
city: Wiesbaden
country: Germany
facility: HSK Dr. Horst Schmidt Kliniken
city: Wittenberg
country: Germany
facility: Evangelisches Krankenhaus Paul Gerhardt Stift, Allgemein-, Viszeral- und Gefäßchirurgie
Study officials:
References: