BurnsNCT01214980
Split Thickness Donor Site Healing With MIST Study
A study testing MIST Therapy in people with Burns and Trauma, run by Celleration, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns, Trauma, Venous Ulcers
- What is being tested?
- MIST Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Controlled Pilot Study of the MIST Therapy System for the Treatment of Split Thickness Donor Sites
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.
Read the 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.
- Conditions
- Burns, Trauma, Venous Ulcers
- Being tested
- MIST Therapy, Standard of care
- Keywords
- Low-frequency ultrasound, Wound healing, Split thickness wound healing, Skin graft donor site healing
- Medical subject headings
- Burns, Wounds and Injuries, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIST TherapyDevice
Also called MIST, MIST Treatment
Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment on a daily basis for 5 days.
Standard of careOther
Also called Standard wound care
Standard of care provided per site-specific protocol
| Study group | Role | What they receive |
|---|---|---|
| MIST Therapy in conjunction with SOC | Experimental | Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment Receives: Device: MIST Therapy |
| Control arm | Active comparator | Standard of care treatment Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Days to absence of drainage from the initial donor site harvest procedure
Secondary outcomes (4)
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.
Measured: Days to full epithelialization
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
Measured: 5 weeks
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
Measured: 5 weeks
Donor Site Recidivism Rate
Number of donor sites that healed and then reopened during the study.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2010 (estimated)
- Study startFeb 2012
- Primary completionJul 2013
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celleration, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa J Gould, M.D.,Ph.D, Principal investigator, James A. Haley Veterans HospitalDavid Smith, MD, Principal investigator, University South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214980
- Sponsor's protocol ID
- CR-86003
- Status last verified
- Dec 2014
- First submitted
- 4 Oct 2010
- Last updated
- 19 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 38837237Prather 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.
PubMed 25868409
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Pilot Study of the MIST Therapy System for the Treatment of Split Thickness Donor Sites
- ClinicalTrials.gov ID
- NCT01214980
- Acronym / sponsor ID
- CR-86003
- Conditions
- Burns, Trauma, Venous Ulcers
- Keywords
- Low-frequency ultrasound, Wound healing, Split thickness wound healing, Skin graft donor site healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Celleration, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 5 Oct 2010 (estimated)
- Results
- Posted 19 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIST Therapy in conjunction with SOC | Experimental | Device: MIST TherapyLow-frequency, non-contact ultrasound administered in conjunction with standard of care treatment |
| Control arm | Active comparator | Other: Standard of careStandard of care treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIST TherapyAlso: MIST, MIST TreatmentLow-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment on a daily basis for 5 days. | Device | MIST Therapy in conjunction with SOC |
| Standard of careAlso: Standard wound careStandard of care provided per site-specific protocol | Other | Control arm |
Primary outcome
Rate of Wound Healing
Time frame: Days to absence of drainage from the initial donor site harvest procedure
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.
4 secondary outcomes
Time to Full Epithelialization
Time frame: Days to full epithelialization
Numeric Pain Score
Time frame: 5 weeks
Numeric Itching Score
Time frame: 5 weeks
Donor Site Recidivism Rate
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38837237Sinha 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.
- Derived from this study: PubMed 25868409Prather 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.
Related trials for Burns
Recruiting
Efferon LPS Hemoadsorption in in Patients With Thermal Burns
Burns
Not yet recruitingObservational study
Recurrence of Extremity Joint Contracture After Z-Plasty Versus Full-Thickness Skin Graft
Joint Contracture, Contracture
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Not yet recruiting
Impact of Range of Motion Exercises on Pain and Functional Ability
Impact of ROM Exercises on Pain and Functional Ability in Patients With Second -Degree Burns
Enrolling by invitationObservational study
Evaluating the Accuracy of Multiple Blood Tests to Diagnose Sepsis in Adult Burn Patients
Sepsis - to Reduce Mortality in the Intensive Care Unit, Burns Involving 20% or More of Body Surface
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa J Gould, M.D.,Ph.D principal investigator
James A. Haley Veterans Hospital
David Smith, MD principal investigator
University South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIST Therapy in people with Burns and Trauma, run by Celleration, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Wound Healing (time frame: Days to absence of drainage from the initial donor site harvest procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01214980, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2014.