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

Myoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00562471
• Other study ID #: ADH-02-1
• Secondary ID: ADH-02-1.1ADH-02
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 20, 2007
• Last updated: November 21, 2007
• Start date: July 2003
• Est. completion date: January 2005

Study information

• Verified date: November 2007
• Source: Angiotech Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Myoma

Intervention

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.
• 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

Locations

Country	Name	City	State
Canada	St. Joseph's Health Centre	Toronto	Ontario
Germany	Klinik für Minimal Invasive Chirurgie	Berlin
Germany	Universitätsklinikum Giessen	Giessen
Germany	Univ. Clinics of Schleswig-Holstein	Kiel
Germany	Bethesda Krankenhaus Wupperta	Wuppertal
Netherlands Antilles	St. Elizabeth Hospital	Curaçao

Sponsors (1)

Lead Sponsor	Collaborator
Angiotech Pharmaceuticals

Countries where clinical trial is conducted

Canada,  Germany,  Netherlands Antilles, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modified American Fertility Society (mAFS) score at the posterior uterus		6-8 weeks following primary myomectomy surgery
Secondary	adhesion extent and tenacity scores at the posterior uterus		6-8 weeks following primary myomectomy surgery