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
- Conditions
- Primary closed abdominal wound with wound healing disorder in the postoperative course after surgical intervention without fascial dehiscence with either a spontaneous dehiscence or a wound that requires an active reopening of the suture by the treating physician. Wounds that cannot be closed by primary intention and requires further treatment to achieve permanent closure.
- Registration Number
- DRKS00000648
- Lead Sponsor
- Private Universität Witten/Herdecke gGmbHFakultät für Gesundheit
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 539
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
Age < 18 years / 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 treatmen / Necrotic tissue with eschar present / Non-enteric and unexplored fistulas / Malignancy of the wound / Elevated intra-abdominal tension over the normal range with existing or foreseeable dysfunction of organs / Use of any other suction device on the study wound within = 8 days prior
to screening / Competing therapies or procedures / Simultaneous participation in other clinical trials
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time (number of days) to achieve complete wound closure<br>Verified by photo documentation and blinded, computer-based wound quality<br>assessment as well as wound closure confirmation after 14 consecutive days<br>(14 days -0 / + 3)<br>Complete wound closure is defined as:<br>100% epithelialization<br>No drainage from the wound<br>No need for adjuvant therapy or dressing<br>No presence of sutures
- Secondary Outcome Measures
Name Time Method 1. Secondary Endpoints: Incidence of confirmed and verified wound closure achieved after a maximum study observation / treatment period of 42 days (+ 14 days to<br>observe sustained closure) / Recurrence of wound opening after confirmed wound closure / Reduction of wound size over time (Reduction in wound volume over time + Reduction in wound surface area over time)<br>2. Safety Endpoints: Incidence of serious adverse events / Incidence of wound-related adverse events and adverse device events / Mortality of any cause (within 132 days from the time of initiation of therapy)<br>3. Patient Reported Outcome (PRO) (Quality of Life (QoL): SF-36® (Visit Wound Closure or End of Maximum Treatment Time, Visit Hospital Discharge, Visit general Follow Up at Day 132 ; Pain; Patient Satisfaction (Visit general Follow Up at Day 132)<br>4. Economic-based outcome measures<br>Direct resource use (Direct medical resource use; Direct nonmedical resource use) / Indirect resource use<br>