The primary purpose of the study is to determine whether two vacuum-wound-dressing techniques (the so called "abdominal dressing" versus "vacuum-pack-technique") are equally effective in the treatment of open abdomen. Secondary purpose is the comparison of feasibility and economic aspects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Negative-pressure-wound-therapy applying a method described by Brock, Barker et al 1995: "Temporary Closure of Open Abdominal Wounds - the Vacuum Pack" (see citations).
Negative-pressure-wound-therapy for temporary abdominal closure applying a device of KCI International (V.A.C.® Abdominal Dressing System). see: http://www.kci-medical.com/kci/corporate/kcitherapies/vactherapy/dressings/abdominal/#
University Medical Centre - Surgical Department
Mannheim, Baden-Wurttemberg, Germany
Failure of delayed abdominal fascial closure (non-prevented ventral hernia) and/or in-hospital-death of any cause (combined primary outcome)
Time frame: until end of vacuum-therapy or death
vacuum-therapy-related morbidity/complications
Time frame: until hospital dismissal or death
length of vacuum-therapy
Time frame: until end of vacuum-therapy or death
costs of vacuum-therapy
Time frame: until end of vacuum-therapy or death
total length of ICU-stay
Time frame: until end of ICU-therapy or death
post-dismissal health-related quality of life (SF36 and EQ-5D questionnaire)
Time frame: 12 weeks after hospital dismissal
recurrent hernia/abdominal wall dehiscence after initial facial closure during hospital stay
Time frame: 12 weeks post hospital dismissal
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