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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||539 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- 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
- 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)
- Recurrence [ Time Frame: 132 days ]Recurrence of wound opening after confirmed wound closure
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
|Brussel, Belgium, 1090|
|Department of Abdominal Surgery Gasthuisberg University Hospital|
|Leuven, Belgium, 3000|
|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|
|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|
|Rotenburg, Germany, 27356|
|Thüringen-Kliniken "Georgius Agricola" GmbH|
|Saalfeld, Germany, 07318|
|GRN-Klinik Sinsheim, Allgemein- und Viszeralchirurgie|
|Sinsheim, Germany, 74889|
|Principal Investigator:||Doerthe Seidel||Witten / Herdecke University|