Efficacy and Safety Study of Anti-Adhesion Product in the Prevention of Intraperitoneal Adhesions
The objective of this study was to evaluate the efficacy of the Anti-Adhesion Product (AAP) in preventing or reducing post-operative adhesion formation and re-formation in a subject population having abdominal surgery and being left with a rectal stump and a temporary stoma from a first procedure and scheduled for a laparoscopy/ laparotomy as a second procedure in the normal treatment of the subjects' disease. In both study groups, surgical measures to prevent adhesions were taken, e.g. using minimum traumatizing surgical technique, using powder-free gloves. In the investigational product group, AAP was applied to the rectal stump and the incision line while no specific additional treatment was applied in the control group. The surgeon assessed preexisting adhesions during the first surgery. Newly developed and re-formed adhesions were evaluated during the second surgery by a surgeon or assistant who did not know the result of randomization. The safety of the study drug was also monitored.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Study to Evaluate the Efficacy and Safety of Anti-Adhesion Product in the Prevention of Intraperitoneal Adhesions|
- Incidence of adhesions around the rectal stump and/or incision line
- Number of subjects with no adhesions
- Extent and severity of adhesions around the rectal stump
- Extent and severity of adhesions at the incision line
- Incidence, extent and severity of adhesions at sites other than the rectal stump and incision line
- Time to reach and free the rectal stump
- Safety (laboratory evaluation, recording of adverse experiences)
|Study Start Date:||December 2000|
|Study Completion Date:||April 2003|
Experimental: Investigational product group
Anti-Adhesion Product was applied to the rectal stump and the incision line.
Like in the control group, surgical measures to prevent adhesions were also taken, e.g. using minimum traumatizing surgical technique, using powder-free gloves.
Biological: Anti-Adhesion Product
Anti-Adhesion Product (AAP) is a biological two-component product of human origin. The components of AAP are lyophilized Anti-Adhesion Protein Concentrate (AAPC), containing fibrinogen, lyophilized Thrombin Concentrate (TC) and the respective diluents for the reconstitution of the components.
No Intervention: Control group
Only surgical measures to prevent adhesions were taken, e.g. using minimum traumatizing surgical technique, using powder-free gloves. No specific additional treatment was applied.
|Copenhagen University Hospital, Rigshospitalet Department of Gastroenterologic Surgery|
|Copenhagen, Denmark, 2120|
|Odense University Hospital, Surgical Gastroenterology Department|
|Odense, Denmark, 5000|
|Im. Marii Sklodowskiej-Curie, Centrum Onkologii-Instytut|
|Warsaw, Poland, 02 781|
|Klinika Chirurgii Ogolnej Onkologicznej i Klatiki Piersiowej CSK WAM|
|Warsaw, Poland, 00 909|
|Göteborg University, Department of Surgery, Colorectal Unit|
|Gothenburg, Sweden, 416 85|
|Söder Sjukhuset, Department of Surgery|
|Stockholm, Sweden, 118 83|
|Uddevalla Sjukhus, Kirurg Kliniken|
|Uddevalla, Sweden, 451 80|
|Principal Investigator:||Baxter BioScience Investigator, MD||Baxter Healthcare Corporation|