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Treatment Study of Vacuum Assisted Closure for Postsurgical Subcutaneous Abdominal Wound Healing Impairments (SAWHI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University of Witten/Herdecke
Sponsor:
Collaborator:
Kinetic Concepts, Inc.
Information provided by (Responsible Party):
Doerthe Seidel, University of Witten/Herdecke
ClinicalTrials.gov Identifier:
NCT01528033
First received: February 2, 2012
Last updated: April 10, 2013
Last verified: April 2013
  Purpose

The Institute for Research in Operative Medicine as part of the Private University of Witten /Herdecke and Kinetic Concepts Incorporated are performing a clinical study to evaluate the efficacy of Vacuum Assisted Closure® (V.A.C.®) Therapy for the treatment of postsurgical abdominal wound healing impairments after surgery. Therefore the underlying layer of fibrous tissue that permeates the internal organs must be intact.

Background of the study is the decision of a german authority, that is responsible for the reimbursement of medical therapies, (Joint Federal Committee of Germany) that Vacuum assisted closure therapy is inadmissible to be a standard benefit of health insurance companies in Germany.

Basis for this decision have been reports of the Institute for Quality and Economic Efficiency in the Healthcare System, which showed an insufficient state of evidence regarding the efficacy of negative pressure wound therapy for the treatment of acute and chronic wounds.

This study will be performed in several hospitals and countries to compare the efficacy of Vacuum Assisted Closure®-therapy with the methods of standard conventional wound therapy according to the existing hospital standard.

Main outcome measure is the time which is needed to achieve a complete and stabile wound closure. Furthermore the therapy options will be examined regarding several other clinical, safety, patient reported and economic parameters.

Patients will be assigned equally and by chance to both treatment groups. Study participants as well as the attending doctors and nurses will be informed about the assignment to the respective treatment arm.

The primary outcome measure (time until complete and confirmed wound closure) and some of the secondary parameters like reappearance of the wound and the development of the wound size over time, examined within an active study treatment time of 42 days, will be photographed and analysed under the use of a central computer system. The central analysing personal will not be informed about patient details or therapy allocation.

Based on already performed studies and the experiences of clinical practise V.A.C.®-therapy is suspected to be faster in achieving a complete and stabile wound closure than standard conventional wound therapy when used for the treatment of postsurgical abdominal wound healing impairments after surgery. Furthermore Vacuum Assisted Closure®-therapy is believed to be an effective and safe treatment option for abdominal wound healing impairments after surgery for inpatient as well as for outpatient care.

belly wounds Patients with at first closed belly wounds with wound healing disorder in the postoperative course after surgery without an opening of the underlying layer of fibrous tissue are eligible to be included in the trial if the diagnosis of a wound healing impairment in the postoperative course is manifested as a wound with spontaneous dehiscence, a wound that requires an active reopening of the suture by the treating physician or a wound that cannot be closed by primary intention and requires further treatment to achieve permanent closure.

Study participants will be selected and enrolled within clinical surgical departments which provide the respective personal, structural and scientific background for the conduction of the trial project.

Trial therapy will be started in-hospital and may be continued in ambulatory care. It is very important to examine the therapy options also in the ambulant care setting thus study participants with good health who are able to continue the specific wound treatment in ambulant should be transferred to the ambulant service as soon as possible.

The results of the study will be provided until the end of 2014 to make a contribution to the final decision of the Joint Federal Committee about Vacuum Assisted Closure® (V.A.C.®) Therapy to be a standard benefit of health insurance companies in Germany for inpatient and / or outpatient care.


Condition Intervention
Wound Healing Disorder
Impaired Wound Healing
Abdominal Wound Healing Disorder
Abdominal Wound Healing Impairment
Acute Postsurgical Subcutaneous Wound
Device: Vacuum Assisted Closure®
Other: Standard conventional wound therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Subcutaneous Abdominal Wound Healing Impairment After Surgery Without Fascial Dehiscence by Vacuum Assisted Closure™(SAWHI-V.A.C.® Study) Versus Standard Conventional Wound Therapy

Further study details as provided by University of Witten/Herdecke:

Primary Outcome Measures:
  • Time to complete wound closure [ Time Frame: 42 days ] [ Designated as safety issue: No ]

    Time (number of days) to achieve complete wound closure verified by photo documentation and blinded, computer-based wound quality assessment as well as wound closure confirmation after 14 consecutive days (14 days -0 / + 3)

    Complete wound closure is defined as:

    100% epithelialization No drainage from the wound No need for adjuvant therapy or dressing No presence of sutures



Secondary Outcome Measures:
  • Incidence of confirmed and verified wound closure [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    Incidence of confirmed and verified wound closure achieved after a maximum study observation / treatment period of 42 days (+ 14 days to observe sustained closure)

  • Recurrence [ Time Frame: 132 days ] [ Designated as safety issue: No ]
    Recurrence of wound opening after confirmed wound closure

  • Wound size over time [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    Reduction of wound size over time (Reduction in wound volume over time + Reduction in wound surface area over time)

  • Serious Adverse Events (SAE) [ Time Frame: 132 days ] [ Designated as safety issue: Yes ]
    Incidence of serious adverse events

  • Adverse Events [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
    Incidence of wound-related adverse events and adverse device events

  • Mortality [ Time Frame: 132 days ] [ Designated as safety issue: Yes ]
    Mortality of any cause (within 132 days from the time of initiation of therapy)

  • Quality of Life (QoL) [ Time Frame: 132 days ] [ Designated as safety issue: No ]
    SF-36® at Visit Wound Closure or End of Maximum Treatment Time, Visit Hospital Discharge if applicable and Visit general Follow Up at Day 132

  • Pain [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    Pain (using a patient diary form Day 1 to Day 42 or until wound closure)

  • Patient Satisfaction [ Time Frame: 132 days ] [ Designated as safety issue: No ]
    Patient Satisfaction (Visit general Follow Up at Day 132)

  • Direct resource use [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    Direct medical resource use 7 Direct nonmedical resource use)

  • Indirect resource use [ Time Frame: 42 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: August 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vacuum Assisted Closure® (V.A.C.®)

Vacuum Assisted Closure® (V.A.C.®) Therapy within a maximum study treatment time of 42 days.

VAC® Therapy Systems used within the trial are ActiV.A.C.®, InfoV.A.C.®, V.A.C. Freedom®, V.A.C. Via® and VAC Ulta® All used systems are equally eligible for the treatment of subcutaneous abdominal wounds and should be used according to availability and local preferences within the trial site.

Systems differ regarding user surface and display and processing of data. For the treatment of subcutaneous abdominal wounds the V.A.C.® Granufoam Dressing (size medium and big) is recommended.

Device: Vacuum Assisted Closure®

Vacuum Assisted Closure® (V.A.C.®) Therapy within a maximum study treatment time of 42 days.

VAC® Therapy Systems used within the trial are ActiV.A.C.®, InfoV.A.C.®, V.A.C. Freedom®, V.A.C. Via® and VAC Ulta®. All used systems are equally eligible for the treatment of subcutaneous abdominal wounds and should be used according to availability and local preferences within the trial site.

Systems differ regarding user surface and display and processing of data. For the treatment of subcutaneous abdominal wounds the V.A.C.® Granufoam Dressing (size medium and big) is recommended.

Other Name: Negative Pressure Wound Therapy
Active Comparator: Standard conventional wound therapy (SCWT)
Standard conventional wound therapy (SCWT) according to institutional clinical standards within a maximum study treatment time of 42 days
Other: Standard conventional wound therapy
Standard conventional wound therapy (SCWT) according to institutional clinical standards within a maximum study treatment time of 42 days

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent
  • Post-surgical subcutaneous abdominal wound healing impairment
  • Wound size: linear wound opening measure of a minimum of 3 cm or a maximum of 30 cm and an overall open wound surface area of a minimum of 9 cm² or a maximum of 180 cm²(confirmed by digital photos)
  • Inclusion, randomization, adequate wound pre-treatment (Debridement)and start of therapy within 48 hours after reopening of the wound, diagnosis for nonclosable wound or in case of spontaneous wound dehiscence

Exclusion Criteria:

  • Age < 18
  • Noncompliance with study procedures, visit schedule and follow up
  • Pregnancy
  • Present or nonclosable defect of the abdominal fascia
  • Indication of direct inflammatory involvement of peritoneum or viscera
  • Any pre-existing or ongoing organ system failure
  • Necrotic tissue with eschar present
  • Non-enteric and unexplored fistulas
  • Malignancy of the wound
  • Elevated intra-abdominal tension over the normal range with existing or foreseeable dysfunction of organs
  • Use of any other suction device on the study wound within ≤ 8 days prior to screening
  • Competing therapies or procedures
  • Simultaneous participation in other clinical trials
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01528033

Contacts
Contact: Doerthe Seidel 0049(0)2219895726 Doerthe.Seidel@uni-wh.de
Contact: Stefanie de Lange, Dr. 0049(0)2219895719 stefanie.deLange@uni-wh.de

Locations
Austria
Medizinische Universität Innsbruck Active, not recruiting
Innsbruck, Austria, 6020
Ludwig Boltzmann Institut für operative Laparoskopie, II. Chirurgie, Allgemeines Krankenhaus (Akh) Active, not recruiting
Linz, Austria, 4020
Germany
Unfallkrankenhaus Berlin Klinik für Allgemein- und Viszeralchirurgie Recruiting
Berlin, Germany, 12683
Contact: Henryk Thielemann, Dr.    +49/30/5681-0    henryk.thielemann@ukb.de   
Sana Klinikum Lichtenberg (Berlin) Recruiting
Berlin, Germany, 10365
Contact: F. Fritze- Büttner, Dr.    0049 30 5518-4471    f.fritze@sana-kl.de   
Charité - Universitätsmedizin Berlin, Klinik für Allgemein-, Visceral- und Transplantationschirurgie Recruiting
Berlin, Germany, 10117
Contact: Jens Neudecker, PD Dr. med.    +49 (304) 50522048    jens.neudecker@charite.de   
Städtisches Klinikum Braunschweig Not yet recruiting
Braunschweig, Germany, 38126
Contact: Guido Schumacher, Prof. Dr. Dr.    0531 595 22 80    chirurgie@klinikum-braunschweig.de   
Contact: Kochergin, Dr.       mkochergin@gmail.com   
Universitätsklinikum Carl Gustav Carus Active, not recruiting
Dresden, Germany, 01307
Universitätsklinikum Düsseldorf Recruiting
Düsseldorf, Germany, 40225
Contact: Wolfgang Knoefel, Univ.-Prof. Dr. med    +49/211/8 11 73 50    knoefel@uni-duesseldorf.de   
Universitätsklinikum Freiburg Not yet recruiting
Freiburg, Germany, 79106
Contact: Stefan Utzolino, Dr.    0761 / 270 -25900    stefan.utzolino@uniklinik-freiburg.de   
Universitätsklinikum Greifswald - Klinik und Poliklinik für Chirurgie - Abt. f. Allg. Chirurgie, Viszeral-, Thorax- und Gefäßchirurgie Recruiting
Greifswald, Germany, 17475
Contact: Stefan Maier, Prof. Dr.    0049/3834/86-6077    maier@uni-greifswald.de   
Universitätsmedizin Göttingen Recruiting
Göttingen, Germany, 37075
Contact: Recca Talaulicar    +49 (551) 398706    r.talaulicar@med.uni-goettingen.de   
Universitätsklinikum des Saarlandes, Klinik für Allgemeine Chirurgie, Viszeral-, Gefäß- und Kinderchirurgie Recruiting
Homburg/Saar, Germany, 66421
Contact: Matthias Glanemann, Prof. Dr.    +49 / 6841/16-31000    matthias.glanemann@uniklinikum-saarland.de   
Rotes Kreuz Krankenhaus Kassel Withdrawn
Kassel, Germany, 34121
Klinikum Kempten-Oberallgäu Active, not recruiting
Kempten, Germany, 87439
Universitätsklinikum Magdeburg A.ö.R., Universitätsklinik für Allgemein-, Viszeral- und Gefäßchirurgie Recruiting
Magdeburg, Germany, 39120
Contact: Olof Jannasch, Dr. med.    +49 (391) 6715527-15500    olof.jannasch@med.ovgu.de   
Universitätsmedizin Mannheim Medizinische Fakultät Mannheim der Universität Heidelberg Chirurgische Klinik Recruiting
Mannheim, Germany, 68167
Contact: Jens Jonescheit, Dr.    +49/621/383-0    Jens-Olaf.Jonescheit@umm.de   
Krankenhaus Ludmillenstift Active, not recruiting
Meppen, Germany, 49716
TU München, Chirurgische Klinik und Poliklinik Recruiting
München, Germany, 81675
Contact: André Mihaljevic, Dr. med.    +49 (89) 41402121    mihaljevic@chir.med.tu-muenchen.de   
Klinikum Nürnberg Nord Active, not recruiting
Nürnberg, Germany, 90419
Evangelisches Krankenhaus Oberhausen Recruiting
Oberhausen, Germany, 46047
Contact: Martin Hüttemann, Dr.       Martin.Huettemann@eko.de   
St. Marien-Hospital Oberhausen Osterfeld, Klinik für Chirurgie und Viszeralchirurgie Recruiting
Oberhausen, Germany, 46117
Contact: Franz-Josef Schumacher, Dr.    +49 / 208 8991-5701    t.rolfs@kk-ob.de   
Chirurgische Klinik I, Klinikum Offenbach GmbH Recruiting
Offenbach, Germany, 63069
Contact: Andreas Zielke, Prof. Dr. med.    +49 /69 / 8405 3941    AZielke@klinikum-offenbach.de   
Klinikum Ernst von Bergmann, Klinik für Allgemein- und Visceralchirurgie Recruiting
Potsdam, Germany, 14467
Contact: Frank Marusch, Prof. Dr. med.    +49 (331) 2415202    fmarusch@klinikumevb.de   
Chirurgische Universitätsklinik Rostock Abteilung für Allgemeine-, Thorax-, Gefäß- und Transplantationschirurgie Recruiting
Rostock, Germany, 18057
Contact: Mark Philipp, Dr.    0049/381/4946167    mark.philipp@med.uni-rostock.de   
GRN-Klinik Sinsheim, Allgemein- und Viszeralchirurgie Recruiting
Sinsheim, Germany, 74889
Contact: Thomas Simon, Dr. med.    +49 (7261) 661251    thomas.simon@grn1.de   
HANSE-Klinikum Stralsund, Klinik für Allgemein-, Viszeral-, Thorax- und Gefäßchirurgie Recruiting
Stralsund, Germany, 18435
Contact: Ingo Klempien, Dr. med.    +49 (3831) 351900    Ingo.Klempien@klinikum-hst.de   
Krankenhaus der Barmherzigen Brüder Recruiting
Trier, Germany, 54292
Contact: Detlef M. Ockert, Prof. Dr. med.    0651 208-2600    d.ockert@bk-trier.de   
Katharinen-Hospital gGmbH, Allgemein- und Viszeralchirurgie Withdrawn
Unna, Germany, 59423
MediClin Müritz-Klinikum Active, not recruiting
Waren, Germany, 17192
Netherlands
University Hospital Maastricht Recruiting
Maastricht, Netherlands, 6202
Contact: Nicole D. Bouvy    +31(43) 3876543    n.bouvy@mumc.nl   
United Kingdom
Nottingham University Hospitals NHS Trust Active, not recruiting
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
University of Witten/Herdecke
Kinetic Concepts, Inc.
Investigators
Principal Investigator: Doerthe Seidel Institut für Forschung in der Operativen Medizin der Privaten Universität Witten / Herdecke gGmbH
Study Chair: Edmund AM Neugebauer, Prof. Dr. Institut für Forschung in der Operativen Medizin der Privaten Universität Witten / Herdecke gGmbH
  More Information

Additional Information:
No publications provided by University of Witten/Herdecke

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Doerthe Seidel, Interim Scientific Leader of the Centre for Clinical Trials and Innovation, University of Witten/Herdecke
ClinicalTrials.gov Identifier: NCT01528033     History of Changes
Other Study ID Numbers: VAC2010-56, 00000648
Study First Received: February 2, 2012
Last Updated: April 10, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Witten/Herdecke:
surgical wound
wound healing disorder
Wound healing impairment
post surgical wound healing disorder
abdominal wound healing impairment
Vacuum Assisted Closure
negative pressure wound therapy

Additional relevant MeSH terms:
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014