CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 43 enrolled
Drug / intervention
Mepitel Onedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01365273
NCT01365273Phase 4Completed
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Open, Prospective, Randomised Investigation Evaluating Pain With the Use of Mepitel One vs.Bridal Veil and Staples on Split Thickness Skin Grafts

Molnlycke Health Care AB·interventional·Posted Jun 3, 2011·Updated Feb 13, 2014

In Brief

A Phase 4 clinical trial evaluating Mepitel One for Deep Partial Thickness Burn and Full Thickness Burns. Completed, enrolled 43 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDeep Partial Thickness Burn, Full Thickness Burns
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 3, 2011
Enrollment StartFeb 1, 2011
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 15.1 years ago

Interventions

Mepitel Onedevice

Dressing