Split Thickness Donor Site Healing With MIST Study

Celleration

Status

Completed

Conditions

Venous Ulcers

Trauma

Burns

Treatments

Device: MIST Therapy

Other: Standard of care

Study type

Interventional

Funder types

Industry

Identifiers

NCT01214980

CR-86003

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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