Microsurfaced Grafts in Deep Burn Wounds

Burns Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04589442
• Other study ID #: MB2019-01
• Status: Recruiting
• Phase: Phase 4
• Start date: January 4, 2021
• Est. completion date: December 2021

Study information

• Verified date: January 2021
• Source: Markman Biologics Corporation
• Contact: Joan Wilson
• Phone: 706-364-2966
• Email: joan.wilson[@]jmsreserachfoundation.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burns
• Wound Heal
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United States	Joseph M Still Research Foundation	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Markman Biologics Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound bed prep	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.	6 week
Secondary	Infection	Incidence of Infection at each treatment study visit	Through 12 months
Secondary	Autograft take	Autograft take will be documented as a percentage of the graft by the physician	2 weeks
Secondary	Tissue oxygenation	Tissue oxygenation will be assessed using hyperspectral imaging	2 weeks
Secondary	Tissue Oxygenation	Change in tissue oxygenation at study burn site at the time of autografting as compared to baseline.	6 weeks
Secondary	Scar assessment	Scar will be assessed using the Patient and Observer Scar Assessment Scale (POSAS)	3, 6, 9, 12 months
Secondary	Tissue oxygenation	Tissue oxygenation will be assessed using hyperspectral imaging	3, 6, 9, 12 months