Split Thickness Donor Site Healing With MIST Study

Trauma Clinical Trial

Official title:

A Prospective, Randomized, Controlled Pilot Study of the MIST Therapy System for the Treatment of Split Thickness Donor Sites

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01214980
• Other study ID #: CR-86003
• Status: Completed
• Phase: N/A
• First received: October 4, 2010
• Last updated: December 18, 2014
• Start date: February 2012
• Est. completion date: July 2014

Study information

• Verified date: December 2014
• Source: Celleration, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns
• Trauma
• Varicose Ulcer
• Venous Ulcers

Intervention

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

Locations

Country	Name	City	State
United States	Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Celleration, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Time to Full Epithelialization	Time to full epithelialization in days from the date of initial donor site harvest procedure per the blinded adjudication of the donor site image.	Days to full epithelialization	No
Secondary	Numeric Pain Score	Average donor site pain score for each treatment group, numeric scale of 0 (no pain) to 10 (worst possible pain), at five weeks post skin graft procedure	5 weeks	No
Secondary	Numeric Itching Score	Average donor site itching score for treatment group, numeric scale 0 (no itch) to 10 (worst possible itch), at 5 weeks post skin graft procedure	5 weeks	No
Secondary	Donor Site Recidivism Rate	Number of donor sites that healed and then reopened during the study.	6 weeks	No