PMCF Study for COSEAL® in Gynecologic Surgery

Completed

Conditions studied: Adhesion

In brief

The study is a single-arm, retrospective, chart review with a patient questionnaire intended to supplement the patient chart, when necessary. The population will consist of patients who underwent an index gynecologic surgery (performed at least 2 years prior to the start of the study) during which COSEAL was used as an adjunct to good surgical technique to reduce the incidence, severity, and extent of post-surgical adhesion formation. The purpose of the study is to detect the incidence of adhesion-related morbidities as measured by the proportion of adhesion-related readmissions, including reoperations in these patients. Patient charts will be reviewed to collect the data on readmissions related to adhesions, If the patient chart has no record of adhesion related readmission within approximately 2 years of the index surgery, then a patient questionnaire will be sent. A questionnaire may still be sent if a patient chart has a record of adhesion related readmission within approximately 2 years of the index surgery and further clarification is needed. The questionnaire will collect information regarding readmission or reoperation directly or possibly related to adhesions following the index gynecologic surgical procedure at a hospital or outpatient clinic other than that of the index surgery.

Key facts

Study ID

NCT05996809

Run by

Baxter Healthcare Corporation

People needed

200

Starts

2024-06-03

Expected to finish

2025-05-08

Last updated by the study team

2025-08-03

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Patients in whom COSEAL was used for the reduction of post-surgical adhesion formation

You may not qualify if…

• Patients who had frank infection in the abdominopelvic cavity at the time of the surgery

Where it is running

• Feinberg School of Medicine — Chicago, Illinois, United States
• Universita Campus Bio Medico di Roma — Rome, Rome, Italy

Full record on ClinicalTrials.gov

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