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Completed

NCT Number: NCT00562471

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

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

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Key information

Conditions

Myoma Cicatrix Fibrosis Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Pathologic Processes Pathological Conditions, Signs and Symptoms Tissue Adhesions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

St. Joseph's Health Centre, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adhibit Adhesion Prevention Gel

Other

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

Standard of Care Comparator

Other

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

Primary outcomes

  1. modified American Fertility Society (mAFS) score at the posterior uterus

    Time frame: 6-8 weeks following primary myomectomy surgery

Secondary outcomes

  1. adhesion extent and tenacity scores at the posterior uterus

    Time frame: 6-8 weeks following primary myomectomy surgery

Sponsors and collaborators

Lead sponsor

Angiotech Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2005
First posted
Nov 22, 2007
Registry last updated
Nov 22, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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