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

NCT04063085 | Completed DMC

• 1 other identifier: RDCT-TWPH
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tissue Adhesion; Gynecologic Surgery

Keywords

Hyaluronan; gel; adhesion agent

Outcome Measures

Primary Outcomes (1)

• The incidence of postoperative adhesion at 3 months

  Divide the number of patients with postoperative adhesion at 3 months in each group by the total number of patients enrolled.

  3 months post-operation

Secondary Outcomes (12)

• The incidence of adverse events in each group from the baseline and during the study period

  14 days, 3, 6, 12, 18, 24 months

• The incidence of each adverse event from the baseline and during the study

  14 days, 3, 6, 12, 18, 24 months

• The severity of adverse events

  14 days, 3, 6, 12, 18, 24 months

• The change of medication or treatment related to adverse event

  14 days, 3, 6, 12, 18, 24 months

• The proportion of sites with adhesions at 3 months

  3 months post-operation

Study Arms (5)

PROTAHERE group

EXPERIMENTAL

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

Device: PROTAHERE Absorbable Adhesion Barrier

Hyalobarrier group

ACTIVE COMPARATOR

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

Device: Hyalobarrier Gel

No treatment group

SHAM COMPARATOR

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

Other: No treatment

Seprafilm group

ACTIVE COMPARATOR

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

Device: Seprafilm Adhesion Barrier

Interceed group

ACTIVE COMPARATOR

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

Device: Gynecare Interceed (TC7) Absorbable Adhesion Barrier

Interventions

PROTAHERE Absorbable Adhesion Barrier DEVICE

40 mg/ml (4%) cross-linked hyaluronan

PROTAHERE group

Hyalobarrier Gel DEVICE

Laparotomy: 40 mg/ml (4%) cross-linked hyaluronan Endoscopy: 30 mg/ml (3%) cross-linked hyaluronan

Hyalobarrier group

No treatment OTHER

No anti-adhesion agent applied

No treatment group

Seprafilm Adhesion Barrier DEVICE

a hyaluronate carboxymethylcellulose-based bioresorbable membrane

Seprafilm group

Gynecare Interceed (TC7) Absorbable Adhesion Barrier DEVICE

an oxidized regenerated cellulose absorbable membrane

Interceed group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SciVision Biotech Inc.: lead
• Taipei Veterans General Hospital, Taiwan: collaborator

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Tissue Adhesions

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 21, 2019
• Study Start: April 25, 2018
• Primary Completion: January 5, 2022
• Study Completion: October 12, 2023
• Last Updated: April 17, 2024

Record last verified: 2023-04

Locations

TW (1)