NCT04063085

The Assessment of the Use of Anti-Adhesion Agents to Prevent Pelvic Postoperative Adhesions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: SciVision Biotech Inc. · Industry
• Sex: Female
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to assess the safety and effectiveness of PROTAHERE Absorbable Adhesion Barrier to prevent pelvic postoperative adhesions.

Detailed description

The study is a random, evaluator-blinded, controlled, single center clinical trial. Recruiting patients who are premenopausal and scheduled for pelvic surgery including myomectomy, pelvic adhenolysis, endometriosis surgery, salpingostomy, dermoid cyst removal, ovarian cystectomy or any pelvic surgery other than total metrectomy. Patients recruited are randomly divided into five groups, PROTAHERE, Hyalobarrier, Seprafilm, Interceed or no treatment when the inclusion criteria are met and the inform consents are obtained. They are followed for 24 months including visits at 14 days, 3, 6, 12, 18, 24 months post-operation for the safety and effectiveness evaluation. The primary endpoints are the incidence of adhesions at 3-month as well as the incidence of any adverse events during the study.

Conditions

• Tissue Adhesion
• Gynecologic Surgery

Interventions

Type	Name	Description
DEVICE	PROTAHERE Absorbable Adhesion Barrier	40 mg/ml (4%) cross-linked hyaluronan
DEVICE	Hyalobarrier Gel	Laparotomy: 40 mg/ml (4%) cross-linked hyaluronan Endoscopy: 30 mg/ml (3%) cross-linked hyaluronan
OTHER	No treatment	No anti-adhesion agent applied
DEVICE	Seprafilm Adhesion Barrier	a hyaluronate carboxymethylcellulose-based bioresorbable membrane
DEVICE	Gynecare Interceed (TC7) Absorbable Adhesion Barrier	an oxidized regenerated cellulose absorbable membrane

Timeline

• Start date: 2018-04-25
• Primary completion: 2022-01-05
• Completion: 2023-10-12
• First posted: 2019-08-21
• Last updated: 2024-04-17

Locations

1 site across 1 country: Taiwan