Clinical study on tissue adhesion preventive devices Trehalose based novel devices for postoperative tissue adhesions

Not Applicable

• Conditions: terine leiomyoma, ovarian tumor, tubal adhesion, caesarotomy

• Registration Number: JPRN-UMIN000000768
• Lead Sponsor: The University of Tokyo Hospital Department of Obstetrics & Gynecology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-07-16
• Study Completion: 2008-08-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

1 Pregnant women, except for cesarean section patients 2 Patients who have received intravenous drip injections and, or perfusates containing dextran, heparin, corticosteroids or nonsteroidal antiinflammatory drugs. 3 Patients who chronically need to receive corticosteroids, or patients who are administered corticosteroids and, or nonsteroidal antiinflammatory drugs within 24 hours prior to surgeries. 4 Patients who have been treated with Interseeds or PRECLUDE surgical membranes or have received other antiadhesion treatments. 5 Patients in the physical conditions that can affect evaluation of safety and efficacy of the present device or Seprafilm. 6 Patients with histories of severe drug allergies. 7 Patients who have received other research products that might affect evaluations of safety and efficacy of the present device during the trial period. 8 Patients with active pelvic inflammatory diseases or peritonitis. 9 Patients who have had open abdominal operations. 10 Patients whose SGOT, SGPT or bilirubin level is more than 20 percent higher than each upper limit. 11 Patients whose BUN and creatinine level are more than 30 percent higher than each upper limit. 12 Patients with severe diabetes mellitus with over 8 percent of HbA1c. 13 Patients who are judged to be inappropriate for the study by doctors in their charge

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Confirmation of safety and efficacy of trehalose-based tissue adhesion preventive devices