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.
Conditions
Interventions
Group 1: 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. V
Sponsors
Private Universität Witten/Herdecke gGmbH
Fakultät für Gesundheit
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion 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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. Secondary Endpoints: 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 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) 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) 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) 4. Economic-based outcome measures Direct resource use (Direct medical resource use; Direct nonmedical resource use) / Indirect resource use | — |
Countries
Belgium, Germany
Contacts
Public ContactDörthe Seidel
Fakultät für Gesundheit Institut für Forschung in der Operativen Medizin Zentrum für Klinische Studien und Innovation
Outcome results
None listed