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Search / Trial NCT00512356

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.

Locations

Copenhagen, , Denmark

Odense, , Denmark

Warsaw, , Poland

Warsaw, , Poland

Gothenburg, , Sweden

Stockholm, , Sweden

Uddevalla, , Sweden

Patients applied

0 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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