Split Thickness Donor Site Healing With MIST Study

NCT01214980 | Completed Results

• 1 other identifier: CR-86003
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Burns; Trauma; Venous Ulcers

Keywords

Low-frequency ultrasound; Wound healing; Split thickness wound healing; Skin graft donor site healing

Outcome Measures

Primary Outcomes (1)

• Rate of Wound Healing

  The primary endpoint is an average of the group for each participant's donor site wound closure time, defined as days to absence of drainage from the date of the initial donor site harvest procedure.

  Days to absence of drainage from the initial donor site harvest procedure

Secondary Outcomes (4)

• Time to Full Epithelialization

  Days to full epithelialization

• Numeric Pain Score

  5 weeks

• Numeric Itching Score

  5 weeks

• Donor Site Recidivism Rate

  6 weeks

Study Arms (2)

MIST Therapy in conjunction with SOC

EXPERIMENTAL

Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment

Device: MIST Therapy

Control arm

ACTIVE COMPARATOR

Standard of care treatment

Other: Standard of care

Interventions

MIST Therapy DEVICE

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

Also known as: MIST, MIST Treatment

MIST Therapy in conjunction with SOC

Standard of care OTHER

Standard of care provided per site-specific protocol

Also known as: Standard wound care

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subject of any race and at least 18 years old
• Subject requires skin grafting
• Subject's wound must be between 20 cm2 and 200 cm2
• Subject's wound presents with no clinical signs of acute infection
• Subject has ahd no prior MIST Therapy to the enrolled wound
• Subject or subject's legally authorized representative understands the nature of the procedure(s) and provides written informed consent prior to study enrollment
• Subject is willing and able to comply with all specified care and visit requirements
• Women of childbearing potential must not be pregnant or lactating, and must be using adequate and accepted contraceptive methods
• Subject has a reasonable expectation of completing the study

You may not qualify if:

• Subject's condition requires the use of topical antibiotics at the time of study enrollment
• Subject's wound would require ultrasound near an electronic implant or prosthesis, e.g., near or over the heart, or over the thoracic area if the subject is using a cardiac pacemaker
• Subject is known to be suffering from a disorder or other situation that the subject or investigator feels would interfere with compliance or other study requirements
• Subject is currently enrolled or has been enrolled in the last 30 days in another investigational device or drug trial

Sponsors & Collaborators

• Celleration, Inc.: lead

Study Sites (1)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Related Publications (2)

• Sinha S, Gabriel VA, Arora RK, Shin W, Scott J, Bharadia SK, Verly M, Rahmani WM, Nickerson DA, Fraulin FO, Chatterjee P, Ahuja RB, Biernaskie JA. Interventions for postburn pruritus. Cochrane Database Syst Rev. 2024 Jun 5;6(6):CD013468. doi: 10.1002/14651858.CD013468.pub2.

  PMID: 38837237 DERIVED

• Prather JL, Tummel EK, Patel AB, Smith DJ, Gould LJ. Prospective Randomized Controlled Trial Comparing the Effects of Noncontact Low-Frequency Ultrasound with Standard Care in Healing Split-Thickness Donor Sites. J Am Coll Surg. 2015 Aug;221(2):309-18. doi: 10.1016/j.jamcollsurg.2015.02.031. Epub 2015 Mar 14.

  PMID: 25868409 DERIVED

MeSH Terms

Conditions

Burns; Wounds and Injuries; Varicose Ulcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

Participants were not blinded to study treatment.

Results Point of Contact

• Title: Dr. Lisa Gould
• Organization: University South Florida

lgould44@hotmail.com

(410) 736-4646

Study Officials

• Lisa J Gould, M.D.,Ph.D

  James A. Haley Veterans Hospital

  PRINCIPAL INVESTIGATOR

• David Smith, MD

  University South Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2010
• First Posted: October 5, 2010
• Study Start: February 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2014
• Last Updated: December 19, 2014
• Results First Posted: December 19, 2014

Record last verified: 2014-12

Locations

US (1)