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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 2016 by University of Witten/Herdecke
Sponsor:
Collaborator:
KCI Europe Holding B.V.
Information provided by (Responsible Party):
Doerthe Seidel, University of Witten/Herdecke
ClinicalTrials.gov Identifier:
NCT01528033
First received: February 2, 2012
Last updated: April 15, 2016
Last verified: April 2016
  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

Resource links provided by NLM:


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: December 2017
Estimated Primary Completion Date: April 2017 (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   (Adult, Senior)
Genders Eligible for Study:   Both
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
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: Carsten Könen 0049(0) 221989 5721 Carsten.Koenen@uni-wh.de

  Show 46 Study Locations
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
Study Chair: Edmund AM Neugebauer, Prof. Dr. Institut für Forschung in der Operativen Medizin der Privaten Universität Witten / Herdecke gGmbH
  More Information

Additional Information:
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 15, 2016
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
Wounds and Injuries
Pathologic Processes

ClinicalTrials.gov processed this record on December 02, 2016