BurnsNCT06857448
Autologous Point-of-Care Adipose Therapy: Recent Injury
A study testing Split Thickness Skin Graft (STSG) and Base of wound fat graft with 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 full-thickness soft-tissue trauma 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?
- Split Thickness Skin Graft (STSG) and Base of wound fat graft with 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
- 68 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Nov 2025to 30 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 unilateral or bilateral fasciotomy of the extremity at any level necessary
- secondary to non-infectious etiology,
- unilateral or bilateral traumatic full-thickness skin loss of the face, head, neck or extremities necessitating reconstruction, and/or
- full or partial thickness burn injury of the face, neck, or extremity requiring excision and/or reconstruction.
- 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: Recent Injury
The goal of this study is to explore if an adipose-based therapeutic strategy can treat full-thickness soft-tissue trauma wounds in injured individuals, especially those with severe burns or soft-tissue loss. The main question it aims to answer are:
- Can immediate autologous adipose and autologous layered composite grafting be effective for acute functional soft-tissue reconstruction?
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 immediate fat grafting into the wound.
- 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 efficacy of immediate autologous adipose and autologous layered Composite Grafting in acute functional soft-tissue reconstruction.
Evaluators including dedicated observers will be blinded to treatment group/strategy.
- Conditions
- Burns, Contracture Scar, Surgical Injury
- Being tested
- Split Thickness Skin Graft (STSG), Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Grafting).
- Keywords
- fasciotomy, trauma
- Medical subject headings
- Burns, Intraoperative Complications, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Split Thickness Skin Graft (STSG)Procedure or surgery
Partial thickness skin in STSGs are performed by harvesting via dermatome the donor site. Donor sites are typically taken from a flat surface on the thigh, lower back, or gluteal region to allow for a graft of even thickness and the selection of donor site is to be based on clinical standard practice. These grafts are placed on the prepared recipient site.
Base of wound fat graft with 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 |
|---|---|---|
| Acute Split Thickness Skin Graft (STSG) Reconstruction | Active comparator | In this Arm, the investigators will evaluate full thickness defects generated after fasciotomy, trauma debridement, and/or burn excision of the face, neck, or extremities. These wounds represent common, full-thickness injuries, which require prolonged recovery and dressing changes as bridge to either skin graft or delayed closure and commonly are associated with contour irregularities, adhesions, and contracture. The investigators will assess current standard of care dressing changes followed by immediate STSG. Receives: Procedure: Split Thickness Skin Graft (STSG) |
| Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Grafting). | Experimental | In this Arm, the investigators will evaluate full thickness defects generated after fasciotomy, trauma debridement, and/or burn excision of the face, neck, or extremities. These wounds represent common, full-thickness injuries, which require prolonged recovery and dressing changes as bridge to either skin graft or delayed closure and commonly are associated with contour irregularities, adhesions, and contracture. The investigators will assess current standard of care dressing changes followed by base of wound fat graft with STSG reconstruction (Autologous Layered Composite Grafting). Receives: Procedure: Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Grafting). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Secondary outcomes (9)
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.
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.
Photographic Appearance of Wound
Photographic evaluation for wound appearance. This is gross appearance.
Measured: From surgery to 9-month clinical endpoint.
Area of Wound
Photographic evaluation for size of wound area. This is measured in cm2
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 Mobility (Resistance to Adhesion)
The investigators will measure tissue mobility under non-invasive tissue stretch. Measurement is achieved by the mm of stretch achievable from a given point under a standardized stress.
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 quality of acute reconstruction across two treatment arms after fasciotomy, trauma and/or burn defects (68 subjects). * Group 1: Split Thickness Skin Graft (STSG) Reconstruction; * Group 2: Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Grafting).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 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
- NCT06857448
- Sponsor's protocol ID
- STUDY24080150 - Recent 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Point-of-Care Adipose Therapy for Reconstruction and Regeneration of Traumatized Skin: Recent Injury
- ClinicalTrials.gov ID
- NCT06857448
- Acronym / sponsor ID
- STUDY24080150 - Recent Injury
- Conditions
- Burns, Contracture Scar, Surgical Injury
- Keywords
- fasciotomy, trauma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Armed Forces Institute of Regenerative Medicine
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to explore if an adipose-based therapeutic strategy can treat full-thickness soft-tissue trauma wounds in injured individuals, especially those with severe burns or soft-tissue loss. The main question it aims to answer are:
- Can immediate autologous adipose and autologous layered composite grafting be effective for acute functional soft-tissue reconstruction?
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 immediate fat grafting into the wound.
- Undergo simultaneous split-thickness skin grafting for full soft-tissue reconstruction.
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 efficacy of immediate autologous adipose and autologous layered Composite Grafting in acute functional soft-tissue reconstruction.
Evaluators including dedicated observers will be blinded to treatment group/strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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 quality of acute reconstruction across two treatment arms after fasciotomy, trauma and/or burn defects (68 subjects). * Group 1: Split Thickness Skin Graft (STSG) Reconstruction; * Group 2: Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Grafting).
| Arm | Type | Receives |
|---|---|---|
| Acute Split Thickness Skin Graft (STSG) Reconstruction | Active comparator | Procedure: Split Thickness Skin Graft (STSG)In this Arm, the investigators will evaluate full thickness defects generated after fasciotomy, trauma debridement, and/or burn excision of the face, neck, or extremities. These wounds represent common, full-thickness injuries, which require prolonged recovery and dressing changes as bridge to either skin graft or delayed closure and commonly are associated with contour irregularities, adhesions, and contracture. The investigators will assess current standard of care dressing changes followed by immediate STSG. |
| Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Grafting). | Experimental | Procedure: Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Grafting).In this Arm, the investigators will evaluate full thickness defects generated after fasciotomy, trauma debridement, and/or burn excision of the face, neck, or extremities. These wounds represent common, full-thickness injuries, which require prolonged recovery and dressing changes as bridge to either skin graft or delayed closure and commonly are associated with contour irregularities, adhesions, and contracture. The investigators will assess current standard of care dressing changes followed by base of wound fat graft with STSG reconstruction (Autologous Layered Composite Grafting). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 unilateral or bilateral fasciotomy of the extremity at any level necessary
- secondary to non-infectious etiology,
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Split Thickness Skin Graft (STSG)Partial thickness skin in STSGs are performed by harvesting via dermatome the donor site. Donor sites are typically taken from a flat surface on the thigh, lower back, or gluteal region to allow for a graft of even thickness and the selection of donor site is to be based on clinical standard practice. These grafts are placed on the prepared recipient site. | Procedure or surgery | Acute Split Thickness Skin Graft (STSG) Reconstruction |
| Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Grafting).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. | Procedure or surgery | Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Grafting). |
Primary outcome
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.
Time frame: From surgery to 9-month clinical endpoint.
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.
9 secondary outcomes
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability).
Time frame: From surgery to 9-month clinical endpoint.
Number of Operative Encounters
Time frame: From surgery to 9-month clinical endpoint.
Percent Graft Take
Time frame: From surgery to 9-month clinical endpoint.
Time to Final Healing/Graft Take
Time frame: From surgery to 9-month clinical endpoint.
Photographic Appearance of Wound
Time frame: From surgery to 9-month clinical endpoint.
Area of Wound
Time frame: From surgery to 9-month clinical endpoint.
Tissue Thickness
Time frame: From surgery to 9-month clinical endpoint.
Pliability (Tensiometry/Cutometry)
Time frame: From surgery to 9-month clinical endpoint.
Tissue Mobility (Resistance to Adhesion)
Time frame: From surgery to 9-month clinical endpoint.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Background: PubMed 25827568Piccolo 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.
- Background: PubMed 28702187Simonacci 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.
- Background: PubMed 32802628Evans 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.
- Background: PubMed 29450855Woodruff 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.
- Background: PubMed 28676850Mokos 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.
- Background: PubMed 27707499Finnerty 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.
- Background: PubMed 29392092Marshall 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.
- Background: PubMed 20415403Wolf 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.
- Background: PubMed 23676968Harrison 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.
- Background: PubMed 29847675Le 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.
- Background: PubMed 35385552D'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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francesco Egro principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Split Thickness Skin Graft (STSG) and Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Grafting). in people with Burns and Contracture Scar, run by University of Pittsburgh at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eleanor Shirley (412-641-8676, shirleye@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: From surgery to 9-month clinical endpoint.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06857448, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.