Evaluating COSEAL® for reducing adhesions after gynecologic surgery
Post-Market Clinical Follow-up Study for COSEAL® in Gynecologic Surgery
Baxter Healthcare Corporation · NCT05996809
This study is looking to see if using COSEAL during gynecologic surgery helps reduce complications from adhesions for patients who had surgery at least two years ago.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Baxter Healthcare Corporation (industry) |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT05996809 on ClinicalTrials.gov |
What this trial studies
This observational study involves a retrospective chart review and patient questionnaires to assess the effectiveness of COSEAL in reducing adhesion-related complications following gynecologic surgeries. It focuses on patients who underwent surgery at least two years prior, during which COSEAL was applied to minimize adhesion formation. The study aims to quantify the incidence of adhesion-related readmissions and reoperations by reviewing patient charts and collecting additional data through questionnaires when necessary.
Who should consider this trial
Good fit: Ideal candidates are adult female patients who had gynecologic surgery at least two years ago where COSEAL was used.
Not a fit: Patients who had infections in the abdominopelvic cavity at the time of surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications related to adhesions for patients undergoing gynecologic surgery.
How similar studies have performed: While this approach is based on existing practices, the specific use of COSEAL in this context is being evaluated for the first time in this manner.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult female patients who, at the time of surgery, were ≥18 years of age and who have undergone an index gynecologic surgery at least 2 years prior to the start of the study. 2. Patients in whom COSEAL was used for the reduction of post-surgical adhesion formation Exclusion Criteria: 1. Patients who had frank infection in the abdominopelvic cavity at the time of the surgery
Where this trial is running
Chicago, Illinois and 1 other locations
- Feinberg School of Medicine — Chicago, Illinois, United States (RECRUITING)
- Universita Campus Bio Medico di Roma — Rome, Italy (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Adhesion, gynecological surgery, adhesion related morbidities