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

Study to Evaluate the Efficacy and Safety 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 Overview

• Status: Completed
• Conditions: Intraperitoneal Adhesions
• Intervention / Treatment: Biological: Anti-Adhesion Product

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2120
    • Copenhagen University Hospital, Rigshospitalet Department of Gastroenterologic Surgery
  • Odense, Denmark, 5000
    • Odense University Hospital, Surgical Gastroenterology Department
• Poland
  • Warsaw, Poland, 00 909
    • Klinika Chirurgii Ogolnej Onkologicznej i Klatiki Piersiowej CSK WAM
  • Warsaw, Poland, 02 781
    • Im. Marii Sklodowskiej-Curie, Centrum Onkologii-Instytut
• Sweden
  • Gothenburg, Sweden, 416 85
    • Göteborg University, Department of Surgery, Colorectal Unit
  • Stockholm, Sweden, 118 83
    • Söder Sjukhuset, Department of Surgery
  • Uddevalla, Sweden, 451 80
    • Uddevalla Sjukhus, Kirurg Kliniken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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)

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation
• Investigators: Principal Investigator: Baxter BioScience Investigator, MD, Baxter Healthcare Corporation

Study record dates

Study Major Dates

• Study Start: December 1, 2000
• Primary Completion (Actual): February 25, 2003
• Study Completion (Actual): April 1, 2003

Study Registration Dates

• First Submitted: August 6, 2007
• First Submitted That Met QC Criteria: August 6, 2007
• First Posted (Estimate): August 7, 2007

Study Record Updates

• Last Update Posted (Actual): August 4, 2017
• Last Update Submitted That Met QC Criteria: August 3, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: 549902