Efficacy and Safety Study of Anti-Adhesion Product in the Prevention of Intraperitoneal Adhesions - Full Text View

Sponsor:	Baxter Healthcare Corporation
Information provided by:	Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT00512356

Purpose

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.

Condition	Intervention	Phase
Intraperitoneal Adhesions	Biological: Anti-Adhesion Product	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Study to Evaluate the Efficacy and Safety of Anti-Adhesion Product in the Prevention of Intraperitoneal Adhesions

Resource links provided by NLM:

MedlinePlus related topics: Adhesions Surgery

U.S. FDA Resources

Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:

Incidence of adhesions around the rectal stump and/or incision line

Secondary Outcome Measures:

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)

Enrollment:	46
Study Start Date:	December 2000
Study Completion Date:	April 2003

Arms	Assigned Interventions
Investigational product group: Experimental 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.
Control group: No Intervention 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Written informed consent obtained from the subject or the subject's legally authorized representative prior to study entry
Male or female subjects > 18 years of age
Subjects undergoing abdominal surgery with the possibility that a rectal stump would remain due to one or more of the following reasons: inflammatory bowel diseases, neoplasm, colon diverticulitis, colonic obstruction, colon polyposis, peritoneal trauma, fistula, incontinence, or other reasons
Subjects for whom a second abdominal surgery is planned within approximately eight months of the first surgical procedure.

Exclusion Criteria:

Pre operative:

Pregnancy and lactation period
Subjects concurrently participating in another clinical trial with a drug or a device
Subjects who have participated in a clinical trial with a drug or a device within 30 days prior to this study
Subjects who have had abdominal/pelvic surgery within six months prior to this study
Subjects who have received or will receive (approximately within the next eight months) abdominal/pelvic irradiation

Intra operative:

Subjects with peritonitis
Subjects with gastrointestinal metastatic cancer, or cancer growing per continuitatem into surrounding tissues
Subjects treated with hemostatic agents (e.g. fibrin sealant, collagen, oxidized cellulose) during the first surgery
Subjects treated with adhesion prevention agents other than the Anti-Adhesion Product (AAP) (e.g. Intergel® Adhesion Prevention Solution, Seprafilm® Membrane) during the first surgery
Subjects with major fecal contamination needing an abdominal lavage during the first surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00512356

Locations

Denmark
Copenhagen University Hospital, Rigshospitalet Department of Gastroenterologic Surgery
Copenhagen, Denmark, 2120
Odense University Hospital, Surgical Gastroenterology Department
Odense, Denmark, 5000
Poland
Im. Marii Sklodowskiej-Curie, Centrum Onkologii-Instytut
Warsaw, Poland, 02 781
Klinika Chirurgii Ogolnej Onkologicznej i Klatiki Piersiowej CSK WAM
Warsaw, Poland, 00 909
Sweden
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

Sponsors and Collaborators

Baxter Healthcare Corporation

Investigators

Principal Investigator:

Baxter BioScience Investigator, MD

Baxter Healthcare Corporation

More Information

No publications provided

Study ID Numbers:	549902
Study First Received:	August 6, 2007
Last Updated:	August 13, 2007
ClinicalTrials.gov Identifier:	NCT00512356 History of Changes
Health Authority:	Sweden: Medical Products Agency; Denmark: Danish Medicines Agency; Poland: Ministry of Health

Additional relevant MeSH terms:

Pathologic Processes
Adhesions

ClinicalTrials.gov processed this record on February 08, 2010