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Open, Prosp, Rand. Invest. Evaluating Pain With Mepitel One vs.Bridal Veil and Staples on Split Thickness Skin Grafts

NCT01365273 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2014-02-13

Study results available
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Summary

This investigation is an open, randomised investigation. Approximately 40 subjects in 4-5 centres in the US with deep-partial of full thickness burns in need of skin grafts will be enrolled.The subjects will be equally randomised to either treatment with Mepitel One or bridal veil together with staples.

The primary objective is to compare pain at the time of dressing change for the use of Mepitel One versus bridal veil together with staples on deep partial or full thickness burns requiring skin grafts.

Conditions

  • Deep Partial Thickness Burn
  • Full Thickness Burns

Interventions

DEVICE

Mepitel One

Dressing

Sponsors & Collaborators

  • Molnlycke Health Care AB

    lead INDUSTRY

Principal Investigators

  • Mary Lou Patton, MD · Nathan Speare Regional Burn Treatment Ctr. Croer Chester Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States

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 NCT01365273 on ClinicalTrials.gov