Using microsurfaced grafts to treat deep burn wounds

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of microsurfaced cadaveric grafts compared to standard control grafts for treating acute deep-partial or full-thickness burn wounds. It employs a prospective, randomized, within-subject controlled design, where participants will receive both types of grafts on adjacent burn sites. The study is divided into two parts: the first part assesses the time to wound bed preparedness over six weeks, while the second part focuses on long-term healing outcomes and scar formation. Participants must have burn injuries that meet specific criteria and will be treated in an outpatient or observational setting.

Why it matters

Who can join: the full rules

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

Where it's running

• Joseph M Still Research Foundation
  Augusta, Georgia, United States Recruiting

Study contacts

• Principal investigator: Claus Brandigi, MD — Joseph M Still Research Foundation
• Study coordinator: Joan Wilson
• Email: joan.wilson@jmsreserachfoundation.org
• Phone: 706-364-2966

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Early detection of sepsis-related blood clotting problems in severe burn patients

  This study tests how well the JAAM-2 score can detect sepsis-induced coagulopathy early in adults with severe burns who develop sepsis in the ICU.

  Recruiting Center for Traumatology and Major Burns, Ben Arous · Tunis · NCT07914205

• THERAVEX Tissue Care Spray Plus for Healing of Skin Wounds and Ulcers

  This observational review tests whether THERAVEX Tissue Care Spray Plus, used with standard wound care, helps heal various skin wounds and chronic ulcers in adults.

  Recruiting Biointelligent Technology Systems SL · Barcelona · NCT07617961

• Efferon LPS hemoadsorption for severe burns

  This study tests whether adding Efferon LPS hemoadsorption to standard care can help burn patients with high illness scores see if their symptoms improve and prevent organ failure.

  Recruiting Efferon JSC · Moscow · NCT07568132

• Vacuum Sealing Drainage to Help Wound Healing After Ob/Gyn Surgical Site Infections

  This study tests whether Vacuum Sealing Drainage (VSD) helps wounds heal faster and reduces complications after obstetric or gynecologic surgeries when infections occur.

  Recruiting Minia University · Minya · NCT07525674

• PowerHeal Bioelectric Bandage for infected open wound recovery

  This tests whether the PowerHeal™ Bioelectric Bandage helps adults with infected traumatic wounds heal faster and clear infection better than standard dressings.

  Recruiting University of Pittsburgh · Ivano-Frankivsk · NCT07329114

• Wearable hip-robot training to improve walking after major lower-leg burns

  This 12-week program will try using a wearable hip-assist robot during daily physiotherapy to help adults who still have walking problems six months after large lower-extremity burns walk better.

  Recruiting Hangang Sacred Heart Hospital · Seoul · NCT07277166

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.