A prospective, randomised, controlled, double-blind phase I-II clinical trial on the safety of A-Part 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
This is a prospective, randomised, controlled, patient blinded and observer blinded, single centre phase I-II trial, which evaluates the safety of A-Part 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.


CONCLUSIONS
This trial aims to assess, whether the intra-peritoneal application of A-Part Gel is safe and efficacious in the prevention of post-surgical adhesions after median laparotomy, in comparison to untreated controls.
Lang
Reinhold
R
Aesculap AG, Department of Clinical Science, Am Aesculap Platz, 78532 Tuttlingen, Germany.
Baumann
Petra
P
Jauch
Karl-Walter
KW
Schmoor
Claudia
C
Weis
Christine
C
Odermatt
Erich
E
Knaebel
Hanns-Peter
HP
D000005:Abdomen / Q000601:surgery*; D058107:Abdominal Wound Closure Techniques; D000328:Adult; D001672:Biocompatible Materials / Q000627:therapeutic use*; D002266:Carboxymethylcellulose Sodium / Q000627:therapeutic use*; D002985:Clinical Protocols; D004338:Drug Combinations; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D010538:Peritonitis; D011142:Polyvinyl Alcohol / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000517:prevention & control*; D011446:Prospective Studies; D000267:Tissue Adhesions / Q000517:prevention & control*; D014945:Wound Healing
C553904:A-Part gel; D001672:Biocompatible Materials; D004338:Drug Combinations; D005782:Gels; D011142:Polyvinyl Alcohol; D002266:Carboxymethylcellulose Sodium