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

NCT00562471 | Completed Phase 1

• 4 other identifiers: ADH-02-1ADH-02-1.1ADH-02-1.2ADH-02-1.3
• Study Type: interventional
• Target: 76
• Locations: 3 countries
• Sites: 6

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

Conditions

Myoma

Keywords

adhesions; gynecologic surgery; laparoscopy; laparotomy; polyethylene glycol; hydrogel; Adhesions following gynecologic surgery to remove myomas

Outcome Measures

Primary Outcomes (1)

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

  6-8 weeks following primary myomectomy surgery

Secondary Outcomes (1)

• adhesion extent and tenacity scores at the posterior uterus

  6-8 weeks following primary myomectomy surgery

Study Arms (2)

1

EXPERIMENTAL

Adhesion Prevention Gel Arm

Other: Adhibit Adhesion Prevention Gel

2

OTHER

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

Interventions

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.

Also known as: CoSeal Surgical Sealant; CoSeal Adhesion Prevention Gel

1

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Angiotech Pharmaceuticals: lead

Study Sites (6)

St. Joseph's Health Centre

Toronto, Ontario, M6R 3B2, Canada

Location

Klinik für Minimal Invasive Chirurgie

Berlin, 14129, Germany

Location

Universitätsklinikum Giessen

Giessen, D-35385, Germany

Location

Univ. Clinics of Schleswig-Holstein

Kiel, 24105, Germany

Location

Bethesda Krankenhaus Wupperta

Wuppertal, 42109, Germany

Location

St. Elizabeth Hospital

Curaçao, Netherlands Antilles

Location

Related Publications (1)

• 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. doi: 10.1093/humrep/den080. Epub 2008 Mar 17.

  PMID: 18346996 DERIVED

MeSH Terms

Conditions

Myoma; Tissue Adhesions

Condition Hierarchy (Ancestors)

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

Study Officials

• Liselotte METTLE, MD, PhD

  Univ. Clinics of Schleswig-Holstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 20, 2007
• First Posted: November 22, 2007
• Study Start: July 1, 2003
• Study Completion: January 1, 2005
• Last Updated: November 22, 2007

Record last verified: 2007-11

Locations

DE (4); CA (1); NE (1)