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

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 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention
Official Title:	A Controlled Randomized Multicenter Study to Assess the Safety and Performance of Adhibit™ Adhesion Prevention Gel in Myomectomy Surgery

Resource links provided by NLM:

MedlinePlus related topics: Adhesions Uterine Fibroids

U.S. FDA Resources

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
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 Name: CoSeal Surgical Sealant; CoSeal Adhesion Prevention Gel
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

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 Name: CoSeal Surgical Sealant; CoSeal Adhesion Prevention Gel

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
Klinik für Minimal Invasive Chirurgie
Berlin, Germany, 14129
Universitätsklinikum Giessen
Giessen, Germany, D-35385
Univ. Clinics of Schleswig-Holstein
Kiel, Germany, 24105
Bethesda Krankenhaus Wupperta
Wuppertal, Germany, 42109
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

No publications provided by Angiotech Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00562471 History of Changes
Other 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
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

Additional relevant MeSH terms:

Tissue Adhesions
Myoma
Cicatrix
Fibrosis
Pathologic Processes

Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 22, 2013