A-Part Gel, an adhesion prophylaxis for abdominal surgery: a randomized controlled phase I-II safety study [NCT00646412].
BACKGROUND
Intra-abdominal surgical intervention can cause the development of intra-peritoneal adhesions. To reduce this problem, different agents have been tested to minimize abdominal adhesions; however, the optimal adhesion prophylaxis has not been found so far. Therefore, the A-Part(®) Gel was developed as a barrier to diminish postsurgical adhesions; the aim of this randomized controlled study was a first evaluation of its safety and efficacy.


METHODS
In this prospective, controlled, randomized, patient-blinded, monocenter phase I-II study, 62 patients received either the hydrogel A-Part-Gel(®) as an anti-adhesive barrier or were untreated after primary elective median laparotomy. Primary endpoint was the occurrence of peritonitis and/or wound healing impairment 28 ± 10 days postoperatively. As secondary endpoints anastomotic leakage until 28 days after surgery, adverse events and adhesions were assessed until 3 months postoperatively.


RESULTS
A lower rate of wound healing impairment and/or peritonitis was observed in the A-Part Gel(®) group compared to the control group: (6.5 vs. 13.8 %). The difference between the two groups was -7.3%, 90 % confidence interval [-20.1, 5.4 %]. Both treatment groups showed similar frequency of anastomotic leakage but incidence of adverse events and serious adverse events were slightly lower in the A-Part Gel(®) group compared to the control. Adhesion rates were comparable in both groups.


CONCLUSIONS
A-Part Gel(®) is safe as an adhesion prophylaxis after abdominal wall surgery but no reduction of postoperative peritoneal adhesion could be found in comparison to the control group. This may at least in part be due to the small sample size as well as to the incomplete coverage of the incision due to the used application.


BACKGROUND
NCT00646412.
Department of Surgery, University Munich-Großhadern, Marchioninistrasse 15, 81377 Munich, Germany.
Reinhold
R
Lang
Aesculap AG, Am Aesculap Platz, 78532 Tuttlingen, Germany.
Petra
P
Baumann
Clinical Trials Unit, University Medical Center Freiburg, Elsässer Strasse 2, 79110 Freiburg, Germany.
Claudia
C
Schmoor
Aesculap AG, Am Aesculap Platz, 78532 Tuttlingen, Germany.
Erich K
EK
Odermatt
Aesculap AG, Am Aesculap Platz, 78532 Tuttlingen, Germany.
Moritz N
MN
Wente
Department of Surgery, University Munich-Großhadern, Marchioninistrasse 15, 81377 Munich, Germany.
Karl-Walter
KW
Jauch
Adhesion prophylaxis; Anastomotic leakage; Carboxymethylcellulose; Intra-abdominal adhesions; Laparotomy; Polyvinylalcohol