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NCT Number: NCT04589442

Microsurfaced Grafts in Deep Burn Wounds

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.

Recruiting

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Joseph M Still Research Foundation

Augusta, Georgia, 30909, United States

Location status: Recruiting

Location contact

Claus Brandigi, MD

PRINCIPAL_INVESTIGATOR

Joan Wilson

CONTACT

[email protected]

706-364-2966

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Split thickness skin graft

Biological

standard of care graft

microsurfaced split thickness skin graft

Biological

standard of care graft that has been microsurfaced

Primary outcomes

  1. Wound bed prep

    Time frame: 6 week

    To compare wound bed preparedness/time to autograft in deep-partial and full thickness burns and burn wound healing in partial thickness burns in burn sites treated with Microsurfaced vs Control cadaveric graft-treated groups through 6 weeks post initial injury.

Secondary outcomes

  1. Infection

    Time frame: Through 12 months

    Incidence of Infection at each treatment study visit

  2. Autograft take

    Time frame: 2 weeks

    Autograft take will be documented as a percentage of the graft by the physician

  3. Tissue oxygenation

    Time frame: 2 weeks

    Tissue oxygenation will be assessed using hyperspectral imaging

  4. Tissue Oxygenation

    Time frame: 6 weeks

    Change in tissue oxygenation at study burn site at the time of autografting as compared to baseline.

  5. Scar assessment

    Time frame: 3, 6, 9, 12 months

    Scar will be assessed using the Patient and Observer Scar Assessment Scale (POSAS)

  6. Tissue oxygenation

    Time frame: 3, 6, 9, 12 months

    Tissue oxygenation will be assessed using hyperspectral imaging

Study contacts

Contact information is provided by the study sponsor or research team.

Joan Wilson

CONTACT

[email protected]

706-364-2966

Sponsors and collaborators

Lead sponsor

CellTherX

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 19, 2020
Registry last updated
Jan 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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