A prospective, randomised, controlled, double-blind phase I-II clinical trial on the safety of A-Part (R) Gel as adhesion prophylaxis after major abdominal surgery versus non-treated group

Background: Postoperative adhesions occur when fibrous strands of
internal scar tissue bind anatomical structures to one another. The
most common cause of intra-abdominal adhesions is previous
intra-abdominal surgical intervention. Up to 74% of intestinal
obstructions are caused by post surgical adhesions. Although a
variety of methods and agents have been investigated to prevent
post surgical adhesions, the problem of peritoneal adhesions
remains largely unsolved. Materials serving as an adhesion barrier
are much needed. Methods/Design: This is a prospective, randomised,
controlled, patient blinded and observer blinded, single centre
phase I-II trial, which evaluates the safety of A-Part (R) Gel as
an adhesion prophylaxis after major abdominal wall surgery, in
comparison to an untreated control group. 60 patients undergoing an
elective median laparotomy without prior abdominal surgery are
randomly allocated into two groups of a 1:1-ratio. Safety parameter
and primary endpoint of the study is the occurrence of wound
healing impairment or peritonitis within 28 (+10) days after
surgery. The frequency of anastomotic leakage within 28 days after
operation, occurrence of adverse and serious adverse events during
hospital stay up to 3 months and the rate of adhesions along the
scar within 3 months are defined as secondary endpoints. After
hospital discharge the investigator will examine the enrolled
patients at 28 (+10) days and 3 months (+/- 14 days) after surgery.
Discussion: This trial aims to assess, whether the intra-peritoneal
application of A-Part (R) Gel is safe and efficacious in the
prevention of post-surgical adhesions after median laparotomy, in
comparison to untreated controls.