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

Sponsor

Angiotech Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00562471

Collaborator

(none)

Enrollment

Locations

Arms

18.1

Duration (Months)

12.7

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Myoma	Other: Adhibit Adhesion Prevention Gel Other: Standard of Care Comparator	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jul 1, 2003

Actual Study Completion Date :

Jan 1, 2005

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

modified American Fertility Society (mAFS) score at the posterior uterus [6-8 weeks following primary myomectomy surgery]

Secondary Outcome Measures

adhesion extent and tenacity scores at the posterior uterus [6-8 weeks following primary myomectomy surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Joseph's Health Centre	Toronto	Ontario	Canada	M6R 3B2
2	Klinik für Minimal Invasive Chirurgie	Berlin		Germany	14129
3	Universitätsklinikum Giessen	Giessen		Germany	D-35385
4	Univ. Clinics of Schleswig-Holstein	Kiel		Germany	24105
5	Bethesda Krankenhaus Wupperta	Wuppertal		Germany	42109
6	St. Elizabeth Hospital	Curaçao		Netherlands Antilles