Efficacy of MySkin Patch for the Healing of Burn Wounds: a Randomised Controlled Trial

NCT01499264 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2014-01-13

No results posted yet for this study

Summary

Evaluation of clinical efficacy of my skin (hydrogel and polyurethane film) plus best practice clinical care in subjects with burn injuries with particular regard to: 1) Wound healing (complete reepithelialization), 2) the patient's pain. In the context of the study will be collected secondary outcomes related to type of lesion and its clinical evolution through the analysis of the items in the scale of the PSST.

Conditions

  • Burns
  • Burn Injury
  • Hydrogel Bandage
  • Occlusive Dressings

Interventions

DEVICE

MySkin patch

Hydrogel and polyurethane film

DEVICE

Traditional Dressing

Gauze and Patch

Sponsors & Collaborators

  • Artsana S.p.a.

    collaborator INDUSTRY
  • Associazione Infermieristica per lo studio delle Lesioni Cutanee

    lead OTHER

Principal Investigators

  • Patrizia Tomasin · Associazione Infermieristica per lo studio delle Lesioni Cutanee

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-09-30
Completion
2014-10-31

Countries

  • Italy

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 NCT01499264 on ClinicalTrials.gov