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

Sponsored by:	Angiotech Pharmaceuticals
Information provided by:	Angiotech Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00562471

Purpose

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	Intervention	Phase
Myoma	Other: Adhibit Adhesion Prevention Gel Other: Standard of Care Comparator	Phase I Phase II

MedlinePlus related topics: Adhesions

Drug Information available for: Lactic acid Ammonium lactate Ringer's lactate Ringer's lactate solution

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Controlled Randomized Multicenter Study to Assess the Safety and Performance of Adhibit™ Adhesion Prevention Gel in Myomectomy Surgery

Further study details as provided by Angiotech Pharmaceuticals:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	76
Study Start Date:	July 2003
Study Completion Date:	January 2005

Arms	Assigned Interventions
1: Experimental 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.
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

Arms

Assigned Interventions

1: Experimental

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.

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562471

Locations

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

Sponsors and Collaborators

Angiotech Pharmaceuticals

Investigators

Principal Investigator:

Liselotte METTLE, MD, PhD

Univ. Clinics of Schleswig-Holstein

More Information

Publications indexed to this study:

Mettler L, Hucke J, Bojahr B, Tinneberg HR, Leyland N, Avelar R. A safety and efficacy study of a resorbable hydrogel for reduction of post-operative adhesions following myomectomy. Hum Reprod. 2008 May;23(5):1093-100. Epub 2008 Mar 17.

Study ID Numbers:	ADH-02-1, ADH-02-1.1, ADH-02-1.2, ADH-02-1.3
Study First Received:	November 20, 2007
Last Updated:	November 21, 2007
ClinicalTrials.gov Identifier:	NCT00562471
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Canada: Health Canada

Keywords provided by Angiotech Pharmaceuticals:

adhesions
gynecologic surgery
laparoscopy
laparotomy

polyethylene glycol
hydrogel
Adhesions following gynecologic surgery to remove myomas

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue
Adhesions
Myoma

Additional relevant MeSH terms:

Neoplasms, Muscle Tissue
Neoplasms
Neoplasms by Histologic Type
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009