Status:
COMPLETED
Treatment Study of Vacuum Assisted Closure for Postsurgical Subcutaneous Abdominal Wound Healing Impairments
Lead Sponsor:
University of Witten/Herdecke
Collaborating Sponsors:
KCI Europe Holding B.V.
Conditions:
Wound Healing Disorder
Impaired Wound Healing
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed Description
The Institute for Research in Operative Medicine as part of the Private University of Witten /Herdecke is planning and performing a clinical trial project to evaluate the efficacy of Vacuum Assisted C...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 2 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2018
Estimated Enrollment :
539 Patients enrolled
Trial Details
Trial ID
NCT01528033
Start Date
August 2 2011
End Date
June 11 2018
Last Update
June 25 2020
Active Locations (15)
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1
UZ Brussel
Brussels, Belgium, 1090
2
Department of Abdominal Surgery Gasthuisberg University Hospital
Leuven, Belgium, 3000
3
Sana Klinikum Lichtenberg (Berlin)
Berlin, Germany, 10365
4
Unfallkrankenhaus Berlin Klinik für Allgemein- und Viszeralchirurgie
Berlin, Germany, 12683