An observational study in Adhesion, sponsored by Baxter Healthcare Corporation. Completed at 2 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-03.
Sponsored by Baxter Healthcare Corporation · Observational
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.
121 studies on the registry are indexed under Tissue Adhesions; 15 are open to participants now.
This study's enrollment of 200 is above the median of 130 across 32 observational studies indexed under Tissue Adhesions.
Browse Tissue Adhesions studies →Baxter Healthcare Corporation is the lead sponsor of 80 studies on the registry; 1 is open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.
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Data will be collected from adult female patient charts in whom COSEAL was used as an adjunct to good surgical technique to reduce the incidence, severity, and extent of post-surgical adhesion formation. Data will also be collected from the questionnaire responses, when necessary
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Exclusion Criteria:
1. Patients who had frank infection in the abdominopelvic cavity at the time of the surgery
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
Device: Coseal
Adhesion reduction
Incidence of hospital readmissions directly or possibly related to adhesions following the use of COSEAL in gynecologic surgery, approximately 2 years from the date of index surgery.
Patient charts will be reviewed to collect the data on readmissions related to adhesions, which are defined as: * Directly related to adhesions (adhesiolysis, non-operative readmissions for adhesions, and adhesiolysis operations on female reproductive tract); * Possibly related to adhesions (gynecologic operations, abdominal surgery, and nonoperative readmissions); * Open or laparoscopic reoperations that could potentially be complicated by present adhesions
Time frame: within 2 years of surgery
Plan to share: Yes — Sharing of Clinical Trial Data: Baxter is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, Baxter will supply anonymized Individual Patient Datasets (IPD) and supporting documents (synopsis of clinical study reports, protocol and SAP's)
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Upon approval of a legitimate research request.
Access criteria: Research requests will be reviewed by qualified medical and scientific experts within the company. If Baxter agrees to the release of clinical data for research purposes, the requestor will be required to sign a data sharing agreement (DSA) in order to ensure protection of patient confidentiality and any intellectual property rights of Baxter prior to the release of any data.
Data sharing details ↗ · www.baxter.com
No publications or documents are linked to this record.
Ran from Jun 2024 to primary completion in May 2025, 11 months.
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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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