BurnsNCT06857435
Autologous Point-of-Care Adipose Therapy: Delayed Injury/Scar
A study testing Full Thickness Skin Graft (FTSG) and Base of wound fat graft with Split Thickness Skin Graft (STSG) Reconstruction (Autologous Layered Composite Grafting). in people with Burns and Contracture Scar, run by University of Pittsburgh at 2 sites in United States.
Trial summary
The goal of this study is to explore if an adipose-based therapeutic strategy can treat contracted scars secondary to soft-tissue burn wounds in injured individuals, especially those with severe burns or soft-tissue loss. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns, Contracture Scar, Surgical Injury
- What is being tested?
- Full Thickness Skin Graft (FTSG) and Base of wound fat graft with Split Thickness Skin Graft (STSG) Reconstruction (Autologous Layered Composite Grafting).
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Nov 2025to 30 Oct 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The proposed study will include adult patients 18 years of age or older,
- male or female,
- civilian, military, active duty or retired veterans
- presenting for scar contracture release and reconstruction at any level.
- Additional inclusion criteria includes willingness to be randomized to receive a fat graft.
Who cannot join
- Age < 18 years of age,
- active infection,
- medical co-morbidities or anatomic configuration deemed by the physician to be a concern for safety,
- unwilling or unable to comply with study procedures,
- radiation to the site of interest,
- prisoners and/or vulnerable populations.
- In addition, candidates that are pregnant or plan to become pregnant in the next year, will be excluded.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Mercy Hospital
Pittsburgh, Pennsylvania, 15219
Eleanor Shirley, 412-641-8676, shirleye@upmc.edu
Francesco Egro
- Recruiting
Presbyterian Hospital
Pittsburgh, Pennsylvania, 15219
Eleanor Shirley, 412-641-8676, shirleye@upmc.edu
Teun Teunis
About this study
Official title: Autologous Point-of-Care Adipose Therapy for Reconstruction and Regeneration of Traumatized Skin: Delayed Injury/Scar
The goal of this study is to explore if an adipose-based therapeutic strategy can treat contracted scars secondary to soft-tissue burn wounds in injured individuals, especially those with severe burns or soft-tissue loss. The main question it aims to answer are:
- Can autologous layered composite grafting demonstrate non-inferiority compared to full-thickness skin grafting for delayed reconstruction of post-burn or trauma scar contracture?
Read more
Researchers will compare the single-stage autologous layered composite grafting method to traditional methods to see if it improves healing outcomes, minimizes scarring, and reduces infection risk.
Participants will:
- Receive fat grafting at time of scar revision.
- Undergo simultaneous split-thickness skin grafting for full soft-tissue reconstruction.
Read the detailed description
Soft-tissue injuries from blasts, burns, or multiple traumas can cause severe damage, leading to loss of function, lower quality of life, long recovery times, and inability to work. When these injuries involve deep burns or full-thickness tissue loss in areas that move a lot, they are especially difficult to treat due to the risk of scarring, stiffness, and tissue sticking together. There is a need for a reliable, single-stage treatment that can provide soft, flexible tissue reconstruction with minimal risk, cost, and, complexity. To address this issue, the investigators propose a fat-based approach to reconstruction. Fat tissue is easily available from the patient's own body and carries many benefits in reconstructive surgery. Our team has shown that using a layer of fat immediately in treatment creates a soft, vascular layer that reduces scarring, improves tissue volume, and supports a one-stage, multi-layer reconstruction without the need for complex surgery or causing harm to the donor area. The purpose of this study is to compare this reconstructive approach under the following conditions:
- Demonstrate non-inferiority of autologous layered composite grafting to full-thickness skin grafting for delayed reconstruction of post-burn/trauma scar contracture.
Evaluators including dedicated observers will be blinded to treatment group/strategy.
- Conditions
- Burns, Contracture Scar, Surgical Injury
- Being tested
- Full Thickness Skin Graft (FTSG), Base of wound fat graft with Split Thickness Skin Graft (STSG) Reconstruction (Autologous Layered Composite Grafting).
- Keywords
- burns, scar contracture
- Medical subject headings
- Burns, Intraoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full Thickness Skin Graft (FTSG)Procedure or surgery
Full thickness skin in FTSGs are harvested by different means by surgeon preference and standard of care. Typically an area of skin with matching color and texture to the site which needs reconstruction is identified from a hidden and/or non-cosmetic area and collected via excision. After excision the donor site is closed and the graft is thinned by using a scalpel or scissors to remove excess fat or other soft tissues from the deep surface before being placed in the donor site.
Base of wound fat graft with Split Thickness Skin Graft (STSG) Reconstruction (Autologous Layered Composite Grafting).Procedure or surgery
Autologous Layered Composite Grafting consists of the layered strategy of simultaneous fat and skin grafting. Fat is harvested by minimally invasive liposuction and applied directly to the wound base without any chemical or biologic processing. Skin is harvested as a split thickness skin graft by dermatome and applied over the layer of adipose tissue.
| Study group | Role | What they receive |
|---|---|---|
| Delayed Full Thickness Skin Graft (FTSG) Reconstruction | Active comparator | In this Arm, the investigators will assess FTSGs for reconstruction of defects after burn scar revision of the face, neck, or extremities. Participants will receive any release and/or preparation of the scar/wound bed as would be standard of care and will then receive reconstruction with a FTSG. Receives: Procedure: Full Thickness Skin Graft (FTSG) |
| Delayed Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Graft) | Experimental | In this Arm, the investigators will assess Autologous Layered Composite Grafting for reconstruction of defects after burn scar revision of the face, neck, or extremities. Participants will receive any release and/or preparation of the scar/wound bed as would be standard of care and will then receive reconstruction with a Autologous Layered Composite Graft. Receives: Procedure: Base of wound fat graft with Split Thickness Skin Graft (STSG) Reconstruction (Autologous Layered Composite Grafting). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in scar contracture, as measured by change in scar surface area size
Contracture as measured by change in surface area of reconstruction between time of surgery and 9-month clinical endpoint/maturation of reconstruction. These data will be derived by serial photography.
Measured: From surgery to 9-month clinical endpoint.
Secondary outcomes (8)
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability).
Incidence of adverse events will be reported for all study participants.
Measured: From surgery to 9-month clinical endpoint.
Total score on the Patient and Observer Scar Assessment Scale (POSAS): Pigmentation, Pliability, Vascularity, Thickness, Relief, and Surface Area, collected at the 9 month follow up visit. Remove
POSAS measures subjective assessment on a 1-10 scale from normal skin to worst scar imaginable across 6 metrics (surface area, vascularity, pigmentation, thickness, pliability and relief). The lowest sum score, reflecting normal skin, is 6 and the highest score, reflecting the worst imaginable scar, is 60.
Measured: From surgery to 9-month clinical endpoint.
Number of Operative Encounters
The investigators will additionally assess early outcome metrics including number of operative encounters.
Measured: From surgery to 9-month clinical endpoint.
Percent Graft Take
The investigators will additionally assess early outcome metrics including percent graft take (% of surface area).
Measured: From surgery to 9-month clinical endpoint.
Time to Final Healing/Graft Take
The investigators will additionally assess early outcome metrics including, time to final healing/graft take in days.
Measured: From surgery to 9-month clinical endpoint.
Tissue Thickness
The investigators will measure tissue thickness as determined by ultrasound.
Measured: From surgery to 9-month clinical endpoint.
Pliability (Tensiometry/Cutometry)
The investigators will utilize a noninvasive cutometer/tensiometer to determine tissue pliability.
Measured: From surgery to 9-month clinical endpoint.
Tissue Adhesion/Mobility
The investigators will measure tissue mobility/resistance to adhesion under non-invasive tissue stretch.
Measured: From surgery to 9-month clinical endpoint.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start4 Nov 2025
- Primary completion31 Jan 2028 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Autologous Layered Composite Grafting consists of the layered strategy of simultaneous fat and skin grafting. Fat is harvested by minimally invasive liposuction and applied directly to the wound base without any chemical or biologic processing. Skin is harvested as per standard of care and applied either to the wound bed directly as per controls or to the layer of adipose tissue. Investigators will compare delayed reconstruction of scar contracture across two treatment arms (40 subjects). * Group 1: Full thickness skin graft (FTSG) Reconstruction; * Group 2: Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Grafting).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Armed Forces Institute of Regenerative Medicine
- Responsible party
- Principal investigator, Francesco Egro, University of Pittsburgh
- Investigators
- Francesco Egro, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857435
- Sponsor's protocol ID
- STUDY24080150 - Delayed Injury
- Status last verified
- Jul 2026
- First submitted
- 4 Feb 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Piccolo NS, Piccolo MS, Piccolo MT. Fat grafting for treatment of burns, burn scars, and other difficult wounds. Clin Plast Surg. 2015 Apr;42(2):263-83. doi: 10.1016/j.cps.2014.12.009. Epub 2015 Feb 21.
PubMed 25827568Simonacci F, Bertozzi N, Grieco MP, Grignaffini E, Raposio E. Procedure, applications, and outcomes of autologous fat grafting. Ann Med Surg (Lond). 2017 Jun 27;20:49-60. doi: 10.1016/j.amsu.2017.06.059. eCollection 2017 Aug.
PubMed 28702187Evans BGA, Gronet EM, Saint-Cyr MH. How Fat Grafting Works. Plast Reconstr Surg Glob Open. 2020 Jul 14;8(7):e2705. doi: 10.1097/GOX.0000000000002705. eCollection 2020 Jul.
PubMed 32802628Woodruff SI, Galarneau MR, McCabe CT, Sack DI, Clouser MC. Health-related quality of life among US military personnel injured in combat: findings from the Wounded Warrior Recovery Project. Qual Life Res. 2018 May;27(5):1393-1402. doi: 10.1007/s11136-018-1806-7. Epub 2018 Feb 15.
PubMed 29450855Mokos ZB, Jovic A, Grgurevic L, Dumic-Cule I, Kostovic K, Ceovic R, Marinovic B. Current Therapeutic Approach to Hypertrophic Scars. Front Med (Lausanne). 2017 Jun 20;4:83. doi: 10.3389/fmed.2017.00083. eCollection 2017.
PubMed 28676850Finnerty CC, Jeschke MG, Branski LK, Barret JP, Dziewulski P, Herndon DN. Hypertrophic scarring: the greatest unmet challenge after burn injury. Lancet. 2016 Oct 1;388(10052):1427-1436. doi: 10.1016/S0140-6736(16)31406-4.
PubMed 27707499Marshall CD, Hu MS, Leavitt T, Barnes LA, Lorenz HP, Longaker MT. Cutaneous Scarring: Basic Science, Current Treatments, and Future Directions. Adv Wound Care (New Rochelle). 2018 Feb 1;7(2):29-45. doi: 10.1089/wound.2016.0696.
PubMed 29392092Wolf JM, Athwal GS, Shin AY, Dennison DG. Acute trauma to the upper extremity: what to do and when to do it. Instr Course Lect. 2010;59:525-38.
PubMed 20415403Harrison BL, Lakhiani C, Lee MR, Saint-Cyr M. Timing of traumatic upper extremity free flap reconstruction: a systematic review and progress report. Plast Reconstr Surg. 2013 Sep;132(3):591-596. doi: 10.1097/PRS.0b013e31829ad012.
PubMed 23676968Le TD, Gurney JM, Nnamani NS, Gross KR, Chung KK, Stockinger ZT, Nessen SC, Pusateri AE, Akers KS. A 12-Year Analysis of Nonbattle Injury Among US Service Members Deployed to Iraq and Afghanistan. JAMA Surg. 2018 Sep 1;153(9):800-807. doi: 10.1001/jamasurg.2018.1166.
PubMed 29847675D'Souza EW, MacGregor AJ, Dougherty AL, Olson AS, Champion HR, Galarneau MR. Combat injury profiles among U.S. military personnel who survived serious wounds in Iraq and Afghanistan: A latent class analysis. PLoS One. 2022 Apr 6;17(4):e0266588. doi: 10.1371/journal.pone.0266588. eCollection 2022.
PubMed 35385552