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Efficacity Assessment of PREVADH® in Adhesion Prevention in Gynaecologic Surgery

NCT01388907 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2016-11-17

Study results available
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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.

Conditions

  • Uterine Fibroids
  • Fertility Disorders

Interventions

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.

Sponsors & Collaborators

  • Registrat-Mapi

    collaborator OTHER

  • Medtronic - MITG

    lead INDUSTRY

Principal Investigators

  • BECKER Patrice · Sofradim Production

  • CANIS Michel, Pr · University Hospital Estaing - 63003 CLERMONT-FERRAND Cedex

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2008-06-30
Completion
2011-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01388907 on ClinicalTrials.gov