NCT01388907

Efficacity Assessment of PREVADH® in Adhesion Prevention in Gynaecologic Surgery

Efficacy and Safety of Prevadh™ in the Prevention of Adhesions in Gynaecological Surgery: a Multicenter, Randomized, French Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: Female
• Age: 20 Years – 42 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate clinically the efficacy of the PREVADH® Film in the prevention of adhesions in gynaecologic surgery, and to assess post-operative complications related to adhesions and pregnancy rate after myomectomy by open surgery.

Detailed description

This study was addressed to patients having an immediate or differed pregnancy desire and presenting a symptomatic or asymptomatic fibroma being able to interfere with fertility. * The primary end point was the assessment of adhesion rate to the uterine surgical sites during a laparoscopic second look performed 10 to 20 weeks post-surgery. * The secondary end points were the assessment, throughout a 3 years follow-up period, of: * pregnancy rate, * adverse events related to adhesions, * adnexal adhesions according to American Fertility Society score, * abdomino-pelvic adhesions according to the modified American Fertility Society score.

Conditions

• Uterine Fibroids
• Fertility Disorders

Interventions

Type	Name	Description
OTHER	Ringer lactate solution	Ringer lactate solution was applied directly onto the uterine surgical sites at the end of the myomectomy surgery, to prevent post-surgical adhesion formation.
DEVICE	Prevadh film	Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formation.

Timeline

• Start date: 2006-05-01
• Primary completion: 2008-06-01
• Completion: 2011-06-01
• First posted: 2011-07-07
• Last updated: 2016-11-17
• Results posted: 2016-11-17

Locations

11 sites across 1 country: France