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Evaluation of Pain Associated With the Removal of Wound Dressing During Care of Venous Leg Ulcer. Comparison of the Efficacy and Safety of Two Dressings Urgotul and TulleGras

NCT02104180 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2022-03-21

Study results available
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Summary

Evaluation of the non-inferiority of TulleGras M.S.® versus Urgotul® in pain associated with removal of wound dressing during care of venous leg ulcer

Conditions

  • Venous Leg Ulcer

Interventions

DEVICE

Urgotul

sterile, hydrocolloid dressing, that consist of a polyester fabric coated with hydrocolloid particles and vaseline

DEVICE

TulleGras M.S.

Sterile dressing that consists of viscose tissue coated with mineral vaseline

Sponsors & Collaborators

  • CEN Biotech

    collaborator INDUSTRY

  • Mylan Inc.

    lead INDUSTRY

Principal Investigators

  • Roger Lesaunier, MD · Mylan Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2016-03-31
Completion
2016-03-31

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 NCT02104180 on ClinicalTrials.gov