Split Thickness Donor Site Healing With MIST Study

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Celleration, Inc.
ClinicalTrials.gov Identifier:
NCT01214980
First received: October 4, 2010
Last updated: March 5, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Burns
Trauma
Venous Ulcers
Device: MIST Therapy
Other: Standard of care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled Pilot Study of the MIST Therapy System for the Treatment of Split Thickness Donor Sites

Resource links provided by NLM:


Further study details as provided by Celleration, Inc.:

Primary Outcome Measures:
  • Rate of wound healing [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    The primary endpoint will be determined by the time to wound closure from the date of each subject's initial donor site harvest procedure.


Secondary Outcome Measures:
  • Cellular and molecular changes in the wound bed [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    The secondary endpoint will be evaluated by molecular protein analysis including: proinflammatory cytokine mediators, inflammatory chemokine mediators, tissue reparative and remodeling mediators (MMPs and TIMPs)


Estimated Enrollment: 30
Study Start Date: February 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MIST Therapy in conjunction with SOC
Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment
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 Names:
  • MIST
  • MIST Treatment
Active Comparator: Control arm
Standard of care treatment
Other: Standard of care
Standard of care provided per site-specific protocol
Other Name: Standard wound care

Detailed Description:

Enrolled subjects will be randomized to receive one of two treatment courses: a) MIST Therapy in conjunction with standard of care (SOC) (treatment group); or b)SOC alone (control group).

On post-op day 1, subjects will undergo a baseline evaluation prior to initiating assigned study treatment, including: wound measurement, wound bed evaluation, description of periwound skin, measurement of type and quantity of exudation, wound clinical symptoms (pain, burning, itching), and digital photography. Subject will then receive assigned study treatment.

SOC includes, but is not limited to, fluid resuscitation, pain medications, systemic antibiotics, control of bleeding, and standard dressings as appropriate for the moisture balance of the wound. SOC also includes providing a hydrocolloid border around the wound with a transparent film dressing over the donor site. No advanced or impregnated dressings are allowed during the study. No topical antibiotics or antibiotic dressings, topical antiseptics (silver, iodine, etc.,) or antimicrobials are allowed.

The transparent film will be removed each day and wound fluid will be collected for analysis. After wound fluid collection, subjects will receive their assigned study treatment. Subjects randomized to receive MIST Therapy will be treated daily for 5 consecutive days. Following administration of the assigned study treatment, subjects will have replacement of the transparent film. The hydrocolloid will remain in place on the border of intact skin.

Evaluations performed will include a wound assessment, digital photography, wound pain assessment and an adverse event assessment. Following the initial 5 day treatment, the study wounds will be dressed per SOC with dressing changes as needed.

Subjects will undergo a weekly wound assessment through 6 weeks from the date of study enrollment. A weekly wound assessment will include the assessment of maintained wound closure, digital photography, and an adverse event assessment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01214980

Locations
United States, Florida
Tampa General Hospital
Tampa, Florida, United States, 33606
Sponsors and Collaborators
Celleration, Inc.
Investigators
Principal Investigator: Lisa J Gould, M.D.,Ph.D James A. Haley Veterans Hospital
Principal Investigator: David Smith, MD University South Florida
  More Information

No publications provided

Responsible Party: Celleration, Inc.
ClinicalTrials.gov Identifier: NCT01214980     History of Changes
Other Study ID Numbers: CR-86003
Study First Received: October 4, 2010
Last Updated: March 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Celleration, Inc.:
Low-frequency ultrasound
Wound healing
Split thickness wound healing
Skin graft donor site healing

Additional relevant MeSH terms:
Varicose Ulcer
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014