A Randomised, Prospective, Multi-Centre Clinical Study of SprayShield™ Adhesion Barrier System as a Barrier for the Prevention of Adhesion Formation After Laparoscopic Myomectomy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fibroid
- Sponsor
- Integra LifeSciences Corporation
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Number of Sites Adherent to the Uterus
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This study is planned as a prospective, randomised, parallel, controlled, multi-centre, open label, comparative evaluation of SprayShield™ Adhesion Barrier plus good surgical technique, versus good surgical technique alone, with a blinded, third party video evaluation of adhesion formation at second look laparoscopy (SLL) following laparoscopic myomectomy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Females, 18 years of age or older, of child-bearing potential.
- •Subject has at least one myoma \>= 3 cm.
Exclusion Criteria
- •Pregnant or lactating females.
- •Females undergoing prior open or closed myomectomy for treatment of myomas.
- •Evidence of current active endometriosis or infection
- •History of or active inflammatory bowel disease or pelvic inflammatory disease.
- •Presence of a frozen pelvis, or hydrosalpinges.
Outcomes
Primary Outcomes
Number of Sites Adherent to the Uterus
Time Frame: 8-12 weeks post myomectomy
The number of times an adhesion is attached to the uterus.
Area of Sites Adherent to the Uterus (cm^2)
Time Frame: 8-12 weeks post myomectomy
Mean Severity Score of Sites Adherent to the Uterus
Time Frame: 8-12 weeks post myomectomy
The scoring for severity is as follows: 0=no adhesions, 1=filmy, avascular adhesions, 2=vascular and/or dense adhesions, and 3=cohesive adhesions.
Mean Extent Score of Sites Adherent to the Uterus
Time Frame: 8-12 weeks post myomectomy
0 =no adhesions, 1=covering \<25% of locations' total area, 2=covering 26% to 50% of locations' total area, and 3=covering \>51% of locations' total area.