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

Primary Purpose

Myoma

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Adhibit Adhesion Prevention Gel
Standard of Care Comparator
Sponsored by
Angiotech Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myoma focused on measuring adhesions, gynecologic surgery, laparoscopy, laparotomy, polyethylene glycol, hydrogel, Adhesions following gynecologic surgery to remove myomas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • St. Joseph's Health Centre
  • Klinik für Minimal Invasive Chirurgie
  • Universitätsklinikum Giessen
  • Univ. Clinics of Schleswig-Holstein
  • Bethesda Krankenhaus Wupperta
  • St. Elizabeth Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

1

2

Arm Description

Adhesion Prevention Gel Arm

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

adhesion extent and tenacity scores at the posterior uterus

Full Information

First Posted
November 20, 2007
Last Updated
November 21, 2007
Sponsor
Angiotech Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00562471
Brief Title
Safety and Efficacy Study of a Hydrogel, Applied Following Removal of Myomas During Gynecologic Surgery, Administered for the Prevention/Reduction of Postoperative Adhesion Formation
Official Title
A Controlled Randomized Multicenter Study to Assess the Safety and Performance of Adhibit™ Adhesion Prevention Gel in Myomectomy Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Angiotech Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myoma
Keywords
adhesions, gynecologic surgery, laparoscopy, laparotomy, polyethylene glycol, hydrogel, Adhesions following gynecologic surgery to remove myomas

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Adhesion Prevention Gel Arm
Arm Title
2
Arm Type
Other
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Adhibit Adhesion Prevention Gel
Other Intervention Name(s)
CoSeal Surgical Sealant; CoSeal Adhesion Prevention Gel
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of Care Comparator
Intervention Description
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 Outcome Measure Information:
Title
modified American Fertility Society (mAFS) score at the posterior uterus
Time Frame
6-8 weeks following primary myomectomy surgery
Secondary Outcome Measure Information:
Title
adhesion extent and tenacity scores at the posterior uterus
Time Frame
6-8 weeks following primary myomectomy surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liselotte METTLE, MD, PhD
Organizational Affiliation
Univ. Clinics of Schleswig-Holstein
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Health Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6R 3B2
Country
Canada
Facility Name
Klinik für Minimal Invasive Chirurgie
City
Berlin
ZIP/Postal Code
14129
Country
Germany
Facility Name
Universitätsklinikum Giessen
City
Giessen
ZIP/Postal Code
D-35385
Country
Germany
Facility Name
Univ. Clinics of Schleswig-Holstein
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Bethesda Krankenhaus Wupperta
City
Wuppertal
ZIP/Postal Code
42109
Country
Germany
Facility Name
St. Elizabeth Hospital
City
Curaçao
Country
Netherlands Antilles

12. IPD Sharing Statement

Citations:
PubMed Identifier
18346996
Citation
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.
Results Reference
derived

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

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