The safety of applying A-Part® Gel intra-peritoneally under the incision in order to prevent post-surgical adhesions after median laparotomy.
Primary Objective: • first assessment of the safety of applying A-Part® Gel as adhesion prophylaxis after major abdominal surgery by specific observation of two major complications of abdominal surgery (wound healing impairment, and/or postoperative peritonitis) in comparison to a control group. Secondary Objectives: * To further evaluate the safety of A-Part® Gel by comparing the incidences of adverse events between the treatment groups (with special attention to anastomosis leakage) * To explore the efficacy of A-Part® Gel in reducing post-surgical adhesions after median laparotomy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
60
10 - 20 ml of A-Part® Gel will be administered before abdominal wall closure in a standardised fashion
Chirurgische Klinik und Poliklinik - Großhadern, Klinikum der Universitaet Muenchen
Munich, Bavaria, Germany
Occurrence of wound healing impairment and/or postoperative peritonitis after surgery
Time frame: 28 (+10) days
Occurrence of anastomosis leakage after surgery
Time frame: within 28 (+10) days
Occurrence of adverse events (AEs) and serious adverse events (SAEs) after surgery
Time frame: postoperative hospital stay and up to 3 months
Adhesion rates along the scar examined by ultrasound-assessment
Time frame: 14 days (range: day 7-14), 28 days (+10 days), 3 months (± 14 days)
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