MedTrace Logo

Split Thickness Donor Site Healing With MIST Study

NCT01214980 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2014-12-19

Study results available
· View outcomes & findings →

Summary

Subjects requiring skin grafting due to burns, trauma, or chronic venous ulcers with split thickness donor sites expected to be between 20 and 200 square cm will be consecutively screened for study eligibility. This study is a prospective, randomized, controlled trial evaluating effect of MIST Therapy on the healing of split thickness skin graft donor sites compared to standard care. Subjects meeting all eligibility criteria and providing appropriate written informed consent will be enrolled for study participation.

Conditions

Interventions

DEVICE

MIST Therapy

Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment on a daily basis for 5 days.

OTHER

Standard of care

Standard of care provided per site-specific protocol

Sponsors & Collaborators

  • Celleration, Inc.

    lead INDUSTRY

Principal Investigators

  • Lisa J Gould, M.D.,Ph.D · James A. Haley Veterans Hospital

  • David Smith, MD · University South Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01214980 on ClinicalTrials.gov