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

SciVision Biotech

Status: Completed

Conditions: Tissue Adhesion; Gynecologic Surgery

Treatments: Device: PROTAHERE Absorbable Adhesion Barrier; Device: Gynecare Interceed (TC7) Absorbable Adhesion Barrier; Device: Seprafilm Adhesion Barrier; Other: No treatment; Device: Hyalobarrier Gel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04063085

RDCT-TWPH

Details and patient eligibility

About

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

Full 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.

Enrollment: 188 patients

Sex: Female

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients who are premenopausal.
• Patients who are 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 who are 20 years old or older.
• Patients who are able to understand the objectives, sign the informed consent form, and willing to comply with study procedures.

Exclusion criteria

• Patients who are 65 years old or older.
• Presence of uncontrolled diabetes, coagulative disorders, severe urinary system infection, or other severe diseases.
• Presence of malignant tumor or diagnosed with cancer.
• Any physical or psychological illness or symptom which is considered unsuitable to enroll by physicians.
• Patients who are unwilling to comply with study procedures.
• Patients who are known to have hypersensitivity to hyaluronic acid implants.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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188 participants in 5 patient groups

PROTAHERE group

Experimental group

Description:

The PROTAHERE group received intra-pelvic PROTAHERE Absorbable Adhesion Barrier during the scheduled pelvic surgery and be followed for 24 months.

Treatment:

Device: PROTAHERE Absorbable Adhesion Barrier

Hyalobarrier group

Active Comparator group

Description:

The Hyalobarrier group received intra-pelvic Hyalobarrier Gel during the scheduled pelvic surgery and be followed for 24 months.

Treatment:

Device: Hyalobarrier Gel

No treatment group

Sham Comparator group

Description:

The no treatment group did not receive any anti-adhesion agent during the scheduled pelvic surgery and be followed for 24 months.

Treatment:

Other: No treatment

Seprafilm group

Active Comparator group

Description:

The Seprafilm group received intra-pelvic Seprafilm Adhesion Barrier during the scheduled pelvic surgery and be followed for 24 months.

Treatment:

Device: Seprafilm Adhesion Barrier

Interceed group

Active Comparator group

Description:

The Interceed group received intra-pelvic Gynecare Interceed (TC7) Absorbale Adhesion Barrier during the scheduled pelvic surgery and be followed for 24 months.

Treatment:

Device: Gynecare Interceed (TC7) Absorbable Adhesion Barrier