CellMistâ„¢ Autologous Cells to Treat Deep Second-Degree Burns (NCT04890574) | Clinical Trial Compass
UnknownPhase 1
CellMistâ„¢ Autologous Cells to Treat Deep Second-Degree Burns
United States14 participantsStarted 2021-05-26
Plain-language summary
The overall purpose of this study is to evaluate the safety of the CellMist™ System in the treatment of deep second degree burns (II°B) in a prospective, multicenter, feasibility pilot study.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Is between 18 and 65 years of age inclusive;
✓. Has at least one discrete deep second degree (II°B) thermal burn injury (≤ 30% Total Body Surface Area (TBSA)) that requires surgical or enzymatic debridement and split thickness skin grafting (STSF) on any body surface excluding the face, joints, perineum and hands;
✓. Agrees to abstain from any other surgical treatment of the wound(s) for the duration of the study unless determined by the Principal Investigator to be medically necessary;
✓. Treatment with CellMist™ occurs with 7 days of burn injury;
✓. Demonstrates (as determined by the Principal Investigator) the ability and willingness to follow the requirements of the protocol;
✓. Understand the full nature and purpose of the study and provides voluntary written informed consent -
Exclusion criteria
✕. Is pregnant or does not agree to use acceptable contraception methods for the duration of their participation in the clinical trial (latter applies to women and men of child bearing potential);
✕. Is breast feeding;
✕. Has a pre-existing local and/or systemic bacterial infection that requires antibiotic treatment for more than 2 days prior to study treatment;
✕. Demonstrates an anesthesia risk that (as determined by the Principal Investigator) prohibits treatment
✕. Body Mass Index (BMI) ≥ 39;
What they're measuring
1
All Adverse Events
Timeframe: We will be evaluating all adverse events reported for the period from enrollment through the final visit which will be 12 months
2
Secondary Surgical Interventions
Timeframe: The evaluation will include all reported secondary surgical interventions for the period from enrollment and up to 12 months
✕. The burn(s) at the target treatment area(s) results from chemical, electrical or radiation exposure;
✕. Has full thickness (III°) burns TBSA ≥ 20%
✕. Has comorbidities and/or medications and/or health status that (as determined by the Principal Investigator) could result in poor cell isolation and/or poor wound healing (e.g., uncontrolled and/or significant diabetes (≥8% HbA1c by medical record), peripheral vascular disease, active malignancy or treatment (other than surgery) of malignancy within the past 3 months, autoimmune disease, renal failure (glomerular filtration rate \<60mL/minute) and/or systemic steroid usage);