Safety and Efficacy Study of a Hydrogel, Applied Following Removal of Myomas During Gynecologic Surgery, Administered for the Prevention/Reduction of Postoperative Adhesion Formation

November 21, 2007 updated by: Angiotech Pharmaceuticals

A Controlled Randomized Multicenter Study to Assess the Safety and Performance of Adhibit™ Adhesion Prevention Gel in Myomectomy Surgery

The purpose of this study was to determine whether the adhesion prevention gel was safe to use, and was effective for the prevention/reduction of adhesion formation that typically occurs following gynecological surgery to remove myomas

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Postoperative adhesions are a common medical complication of gynecologic and pelvic surgeries, and are frequently associated with chronic or recurrent pelvic pain, intestinal obstruction and infertility. This randomized, controlled, multicenter, clinical study was designed to evaluate the safety and performance of Adhibit™ Adhesion Prevention Gel versus the standard of care for the reduction of postoperative adhesions in subjects undergoing myomectomy via laparotomy or laparoscopy. Subjects were scheduled to return within 6-8 weeks after the initial surgical procedure. At that time, a second-look laparoscopy was performed for postoperative adhesion assessment. Adhesions were graded using a modified American Fertility Society (mAFS) scoring method.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6R 3B2
        • St. Joseph's Health Centre
  • Germany
      • Berlin, Germany, 14129
        • Klinik für Minimal Invasive Chirurgie
      • Giessen, Germany, D-35385
        • Universitätsklinikum Gießen
      • Kiel, Germany, 24105
        • Univ. Clinics of Schleswig-Holstein
      • Wuppertal, Germany, 42109
        • Bethesda Krankenhaus Wupperta
  • Netherlands Antilles
      • Curaçao, Netherlands Antilles
        • St. Elizabeth Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Preoperatively, subjects must have had:

  • Been scheduled for myomectomy via laparotomy or laparoscopy.
  • Agreed to a second-look laparoscopic procedure to assess and lyse any adhesions formed at 6 to 8 weeks following myomectomy.
  • Been >=18 years of age.
  • Provided voluntary written informed consent.
  • Been willing to comply with all aspects of the treatment and evaluation schedule.

Intra-operatively, subjects must have had:

  • Had at least one 2 cm incision length on posterior uterine surface, which may include the fundal surface.

Exclusion Criteria:

Preoperatively, subjects must not have had:

  • Been pregnant.
  • Had a pelvic malignancy.
  • Had acute pelvic inflammatory disease.
  • Had an immune compromised condition.
  • Been a participant in another clinical research study which the investigator believed could interfere with the purpose of this study.
  • Been given corticosteroids intra-operatively or during the course of the postoperative study follow up.

Intra-operatively, subjects must not have had:

  • Had a pelvic malignancy.
  • Had a pelvic or abdominal infection.
  • Had acute pelvic inflammatory disease.
  • Received any adhesion prevention adjuvants or barriers, or peritoneal instillates containing corticosteroids, NSAIDs, or Dextran.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Adhesion Prevention Gel Arm
Other: Adhibit Adhesion Prevention Gel
A resorbable hydrogel, which adheres to itself and the tissues it contacts, is approved for use in sealing vascular reconstructions. The hydrogel is formed when two synthetic derivatized polyethylene glycol (PEG) polymers are mixed together and applied to tissue. Using a gas-assisted delivery device, the hydrogel is sprayed over all myomectomy suture lines and all surgically treated areas during the myomectomy surgery. The hydrogel is totally resorbed within 30 days post-application.
Other Names:
  • CoSeal Surgical Sealant; CoSeal Adhesion Prevention Gel
Other: 2
Standard of Care Comparator Arm (standard of care for post-operative adhesion prevention included irrigation of tissues and lavage of all fluids with Ringers Lactate solution following surgery and 300 to 500mL of solultion left in the pelvic cavity immediately prior to wound closure)
Other: Standard of Care Comparator
standard of care for post-operative adhesion prevention included irrigation of tissues and lavage of all fluids with Ringers Lactate solution following surgery and 300 to 500mL of solultion left in the pelvic cavity immediately prior to wound closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
modified American Fertility Society (mAFS) score at the posterior uterus
Time Frame: 6-8 weeks following primary myomectomy surgery
6-8 weeks following primary myomectomy surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
adhesion extent and tenacity scores at the posterior uterus
Time Frame: 6-8 weeks following primary myomectomy surgery
6-8 weeks following primary myomectomy surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Angiotech Pharmaceuticals

Investigators

  • Principal Investigator: Liselotte METTLE, MD, PhD, Univ. Clinics of Schleswig-Holstein

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion

December 6, 2022

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

November 20, 2007

First Submitted That Met QC Criteria

November 21, 2007

First Posted (Estimate)

November 22, 2007

Study Record Updates

Last Update Posted (Estimate)

November 22, 2007

Last Update Submitted That Met QC Criteria

November 21, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADH-02-1
  • ADH-02-1.1
  • ADH-02-1.2
  • ADH-02-1.3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myoma

Clinical Trials on Adhibit Adhesion Prevention Gel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe