Efficacy and Safety Study of Anti-Adhesion Product in the Prevention of Intraperitoneal Adhesions
Launched by BAXTER HEALTHCARE CORPORATION · Aug 6, 2007
Trial Information
Current as of May 13, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
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
About Baxter Healthcare Corporation
Baxter Healthcare Corporation is a global leader in the healthcare industry, dedicated to advancing medical innovation and improving patient outcomes through its comprehensive portfolio of products and services. With a strong focus on areas such as renal care, surgical solutions, and hospital products, Baxter leverages cutting-edge research and development to address the evolving needs of patients and healthcare providers. The company is committed to conducting high-quality clinical trials that adhere to rigorous ethical standards, ensuring the safety and efficacy of its therapies while fostering collaboration with healthcare professionals and regulatory bodies worldwide. Baxter's mission is to enhance the quality of life for patients through innovative and reliable healthcare solutions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Copenhagen, , Denmark
Odense, , Denmark
Warsaw, , Poland
Warsaw, , Poland
Gothenburg, , Sweden
Stockholm, , Sweden
Uddevalla, , Sweden
Patients applied
Trial Officials
Baxter BioScience Investigator, MD
Principal Investigator
Baxter Healthcare Corporation
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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