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

NCT ID: NCT00512356

Last Updated: 2017-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-12-31
• Study Completion Date: 2003-04-30

Brief Summary

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.

Conditions

Intraperitoneal Adhesions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Anti-Adhesion Product

Intervention Type: BIOLOGICAL

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: lead

Principal Investigators

Baxter BioScience Investigator, MD

Role: PRINCIPAL_INVESTIGATOR

Baxter Healthcare Corporation

Locations

Copenhagen University Hospital, Rigshospitalet Department of Gastroenterologic Surgery

Copenhagen, , Denmark

Odense University Hospital, Surgical Gastroenterology Department

Odense, , Denmark

Klinika Chirurgii Ogolnej Onkologicznej i Klatiki Piersiowej CSK WAM

Warsaw, , Poland

Im. Marii Sklodowskiej-Curie, Centrum Onkologii-Instytut

Warsaw, , Poland

Göteborg University, Department of Surgery, Colorectal Unit

Gothenburg, , Sweden

Söder Sjukhuset, Department of Surgery

Stockholm, , Sweden

Uddevalla Sjukhus, Kirurg Kliniken

Uddevalla, , Sweden

Countries

Denmark; Poland; Sweden

Other Identifiers

549902

Identifier Type: -

Identifier Source: org_study_id