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

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ClinicalTrials.gov Identifier: NCT01528033
Recruitment Status : Recruiting
First Posted : February 7, 2012
Last Update Posted : August 10, 2017
Sponsor:
Collaborator:
KCI Europe Holding B.V.
Information provided by (Responsible Party):
Doerthe Seidel, University of Witten/Herdecke

Study Description
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Brief Summary:

This clinical study is performed in several German, Dutch and Belgian hospitals to evaluate the efficacy of Vacuum Assisted Closure® (V.A.C.®) 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.

Main outcome measure is the time until complete wound closure that sustained for a minimum of 14 days. 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 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.

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.


Condition or disease Intervention/treatment Phase
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 Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : August 2011
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Vacuum Assisted Closure®
Negative pressure wound therapy
 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
According to institutional clinical standards
 Other: Standard conventional wound therapy
Standard conventional wound therapy (SCWT) according to institutional clinical standards within a maximum study treatment time of 42 days


Outcome Measures
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Primary Outcome Measures :
  1. Time to complete wound closure [ Time Frame: 42 days ]

    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 :
  1. Incidence of confirmed and verified wound closure [ Time Frame: 42 days ]
    Incidence of confirmed and verified wound closure achieved after a maximum study observation / treatment period of 42 days (+ 14 days to observe sustained closure)

  2. Recurrence [ Time Frame: 132 days ]
    Recurrence of wound opening after confirmed wound closure

  3. Wound size over time [ Time Frame: 42 days ]
    Reduction of wound size over time (Reduction in wound volume over time + Reduction in wound surface area over time)

  4. Serious Adverse Events (SAE) [ Time Frame: 132 days ]
    Incidence of serious adverse events

  5. Adverse Events [ Time Frame: 42 days ]
    Incidence of wound-related adverse events and adverse device events

  6. Mortality [ Time Frame: 132 days ]
    Mortality of any cause (within 132 days from the time of initiation of therapy)

  7. Quality of Life (QoL) [ Time Frame: 132 days ]
    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

  8. Pain [ Time Frame: 42 days ]
    Pain (using a patient diary form Day 1 to Day 42 or until wound closure)

  9. Patient Satisfaction [ Time Frame: 132 days ]
    Patient Satisfaction (Visit general Follow Up at Day 132)

  10. Direct medical resource use [ Time Frame: 42 days ]
    diagnostics, medication, specific wound therapy, treatment and medical attendance, reinterventions, rehospitalisations

  11. Indirect medical resource use [ Time Frame: 42 days ]
    restrictions of productivity besides absence from the workplace (activities of daily living); non-productive time for gainfully employed


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent
  • Post-surgical subcutaneous abdominal wound healing impairment
  • Minimum wound size eligible for the application of the randomized treatment- 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
  • Any pre-existing or ongoing organ system failure, that cannot be stabilized or solved by appropriate medical treatment
  • Necrotic tissue with eschar present
  • Non-enteric and unexplored fistulas
  • Malignancy of the wound
  • Use of any other device based on the principle of negative pressure wound therapy on the study wound within ≤ 8 days prior to screening
  • Competing therapies or procedures
  • Simultaneous participation in other clinical trials
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01528033


Contacts
Contact: Doerthe Seidel 0049(0)2219895726 Doerthe.Seidel@uni-wh.de
Contact: Stefan Bauer 0049(0) 221989 5735 Stefan.Bauer@uni-wh.de

Locations
Belgium
UZ Brussel Recruiting
Brussel, Belgium, 1090
Contact: Mathias Allaeys       mathias.allaeys@uzbrussel.be   
Department of Abdominal Surgery Gasthuisberg University Hospital Recruiting
Leuven, Belgium, 3000
Contact: Marc Miserez, Prof.       marc.miserez@uzleuven.be   
Germany
Sana Klinikum Lichtenberg (Berlin) Recruiting
Berlin, Germany, 10365
Contact: F. Fritze- Büttner, Dr.    0049 30 5518-4471    f.fritze@sana-kl.de   
Unfallkrankenhaus Berlin Klinik für Allgemein- und Viszeralchirurgie Recruiting
Berlin, Germany, 12683
Contact: Henryk Thielemann, Dr.    +49/30/5681-0    henryk.thielemann@ukb.de   
St. Josef-Hospital gGmbH Universitätsklinikum der Ruhr-Universität Bochum Recruiting
Bochum, Germany, 44791
Contact: Waldemar Uhl, Prof. Dr.       k.kasoly@klinikum-bochum.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, Germany, 66421
Contact: Matthias Glanemann, Prof. Dr.    +49 / 6841/16-31000    matthias.glanemann@uniklinikum-saarland.de   
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Recruiting
Mainz, Germany, 55131
Contact: Grimminger, Dr.       peter.grimminger@unimedizin-mainz.de   
Universitätsmedizin Mannheim Medizinische Fakultät Mannheim der Universität Heidelberg Chirurgische Klinik Recruiting
Mannheim, Germany, 68167
Contact: Florian Herrle, Dr.       Florian.herrle@umm.de   
Chirurgische Klinik und Poliklinik, Klinikum rechts der Isar Recruiting
München, Germany, 81675
Contact: André Mihaljevic, Dr. med.    +49 (89) 41402121    mihaljevic@chir.med.tu-muenchen.de   
Ruppiner Kliniken GmbH Recruiting
Neuruppin, Germany, 16816
Contact: Stephan Gretschel, PD Dr.       ach@ruppiner-kliniken.de   
Klinikum Ernst von Bergmann, Klinik für Allgemein- und Visceralchirurgie Recruiting
Potsdam, Germany, 14467
Contact: Frank Marusch, Prof. Dr.    +49 (331) 2415202    fmarusch@klinikumevb.de   
Diakoniekrankenhaus Rotenburg Recruiting
Rotenburg, Germany, 27356
Contact: Oleg Heizmann, PD Dr.       O.Heizmann@diako-online.de   
Thüringen-Kliniken "Georgius Agricola" GmbH Recruiting
Saalfeld, Germany, 07318
Contact: Thomas Krönert, Dr.       tkroenert@thueringen-kliniken.de   
GRN-Klinik Sinsheim, Allgemein- und Viszeralchirurgie Recruiting
Sinsheim, Germany, 74889
Contact: Tobias Gehrig, Dr.       tobias.gehrig@grn.de   
Sponsors and Collaborators
University of Witten/Herdecke
KCI Europe Holding B.V.
Investigators
Principal Investigator: Doerthe Seidel Institut für Forschung in der Operativen Medizin der Privaten Universität Witten / Herdecke gGmbH
More Information
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Additional Information:
Study Website  This link exits the ClinicalTrials.gov site
Sponsor  This link exits the ClinicalTrials.gov site

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 ( Registry Identifier: DRKS )
First Posted: February 7, 2012    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017

Keywords provided by Doerthe Seidel, 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
Wounds and Injuries
Pathologic Processes