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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 : Completed
First Posted : February 7, 2012
Results First Posted : June 25, 2020
Last Update Posted : June 25, 2020
Sponsor:
Collaborator:
KCI Europe Holding B.V.
Information provided by (Responsible Party):
Doerthe Seidel, University of Witten/Herdecke

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 539 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
Actual Study Start Date : August 2, 2011
Actual Primary Completion Date : March 14, 2018
Actual Study Completion Date : June 11, 2018

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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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

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


Locations
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Belgium
UZ Brussel
Brussel, Belgium, 1090
Department of Abdominal Surgery Gasthuisberg University Hospital
Leuven, Belgium, 3000
Germany
Sana Klinikum Lichtenberg (Berlin)
Berlin, Germany, 10365
Unfallkrankenhaus Berlin Klinik für Allgemein- und Viszeralchirurgie
Berlin, Germany, 12683
St. Josef-Hospital gGmbH Universitätsklinikum der Ruhr-Universität Bochum
Bochum, Germany, 44791
Universitätsmedizin Göttingen
Göttingen, Germany, 37075
Universitätsklinikum des Saarlandes, Klinik für Allgemeine Chirurgie, Viszeral-, Gefäß- und Kinderchirurgie
Homburg, Germany, 66421
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität
Mainz, Germany, 55131
Universitätsmedizin Mannheim Medizinische Fakultät Mannheim der Universität Heidelberg Chirurgische Klinik
Mannheim, Germany, 68167
Chirurgische Klinik und Poliklinik, Klinikum rechts der Isar
München, Germany, 81675
Ruppiner Kliniken GmbH
Neuruppin, Germany, 16816
Klinikum Ernst von Bergmann, Klinik für Allgemein- und Visceralchirurgie
Potsdam, Germany, 14467
Diakoniekrankenhaus Rotenburg
Rotenburg, Germany, 27356
Thüringen-Kliniken "Georgius Agricola" GmbH
Saalfeld, Germany, 07318
GRN-Klinik Sinsheim, Allgemein- und Viszeralchirurgie
Sinsheim, Germany, 74889
Sponsors and Collaborators
University of Witten/Herdecke
KCI Europe Holding B.V.
Investigators
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Principal Investigator: Doerthe Seidel Witten / Herdecke University
  Study Documents (Full-Text)

Documents provided by Doerthe Seidel, University of Witten/Herdecke:
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Doerthe Seidel, Interim Scientific Leader of the Centre for Clinical Trials and Innovation, University of Witten/Herdecke
ClinicalTrials.gov Identifier: NCT01528033    
Other Study ID Numbers: VAC2010-56
00000648 ( Registry Identifier: DRKS )
First Posted: February 7, 2012    Key Record Dates
Results First Posted: June 25, 2020
Last Update Posted: June 25, 2020
Last Verified: June 2020
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:
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Disease
Wounds and Injuries
Pathologic Processes