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Recruiting NCT04589442

Microsurfaced Grafts in Deep Burn Wounds

Phase IV Interventional Burns Wound Heal

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Split thickness skin graft, microsurfaced split thickness skin graft.
Who it may be relevant to
Registry conditions: Burns, Wound Heal. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective, Randomized Study to Evaluate the Effectiveness of Microsurfaced vs Control Cadaveric Decellularized Grafts to Establish Wound Bed Preparedness in Deep Partial and Full Thickness Burn Wounds

Overview

This study is designed as a prospective, randomized, within subject controlled design to evaluate the effectiveness of Microsurfaced vs Control cadaveric grafts for coverage of acute deep-partial or full-thickness burn wounds to promote wound healing. This study will be performed in 2 parts: Time to wound bed preparedness through 6 weeks (Part A) and wound site healing, graft take and long-term scar outcomes (Part B). Subjects will be treated with both control and microsurfaced cadaveric grafts on adjacent deep-partial or full-thickness burn wounds.

Interventions

  • Biological Split thickness skin graft
    standard of care graft
  • Biological microsurfaced split thickness skin graft
    standard of care graft that has been microsurfaced

Primary outcome measures

  • Wound bed prep [Time frame: 6 week]
Secondary outcome measures (6)
  • Infection [Time frame: Through 12 months]
  • Autograft take [Time frame: 2 weeks]
  • Tissue oxygenation [Time frame: 2 weeks]
  • Tissue Oxygenation [Time frame: 6 weeks]
  • Scar assessment [Time frame: 3, 6, 9, 12 months]
  • Tissue oxygenation [Time frame: 3, 6, 9, 12 months]

Eligibility criteria

Inclusion criteria

  • Signed informed consent by patient or Legally Authorized Representative (LAR)
  • Subject with deep partial or full thickness burn injury due to flame burn, scald injury or contact burn
  • Study burn site large enough to accommodate placement of control and microsurfaced cadaveric graft (minimum 4 cm2 each) at the same location OR 2 study burn sites large enough to each accommodate control and microsurfaced cadaveric graft, respectively at minimum 4 cm2.
  • Total Body Surface Area burned (TBSA) total ≤30 %
  • Admission within 72 hours of burn injury
  • Non-infected wound as diagnosed by the attending physician upon admission
  • Treated as an outpatient or in an observational setting
  • 21 years of age or older

Exclusion criteria

  • Burns involving the face
  • Causes other than contact burn, flame or scald injuries (i.e., electrical, chemical or frostbite)
  • Admission time greater than 72 hours after the injury
  • Wounds noted to be infected at admission
  • Is pregnant or plans to become pregnant
  • Is nursing or actively lactating
  • Developmental disability/significant psychological disorder that in the opinion of the investigator could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures, including untreated schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years.
  • Active alcohol or substance abuse in the opinion of the investigator that could impair the subject's participation in the study protocol or record study materials
  • Any medical condition or co-morbidity that in the opinion of the investigator, would prevent successful participation in the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Joseph M Still Research Foundation — Augusta

Identifiers

NCT: NCT04589442 · MB2019-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗