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

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00512356
First received: August 6, 2007
Last updated: August 13, 2007
Last verified: August 2007
  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 2

Study Type: Interventional
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

Resource links provided by NLM:


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
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional relevant MeSH terms:
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on November 23, 2014