Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-02-27 @ 12:49 AM
Study NCT ID:
NCT06857435
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-05
First Post:
2025-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Point-of-Care Adipose Therapy: Delayed Injury/Scar
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}, {'id': 'D007431', 'term': 'Intraoperative Complications'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019651', 'term': 'Plastic Surgery Procedures'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.\n\nInvestigators will compare delayed reconstruction of scar contracture across two treatment arms (40 subjects).\n\n* Group 1: Full thickness skin graft (FTSG) Reconstruction;\n* Group 2: Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Grafting).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-03', 'studyFirstSubmitDate': '2025-02-04', 'studyFirstSubmitQcDate': '2025-02-26', 'lastUpdatePostDateStruct': {'date': '2025-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in scar contracture, as measured by change in scar surface area size', 'timeFrame': 'From surgery to 9-month clinical endpoint.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability).', 'timeFrame': 'From surgery to 9-month clinical endpoint.', 'description': 'Incidence of adverse events will be reported for all study participants.'}, {'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. Remove', 'timeFrame': 'From surgery to 9-month clinical endpoint.', 'description': '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.'}, {'measure': 'Number of Operative Encounters', 'timeFrame': 'From surgery to 9-month clinical endpoint.', 'description': 'The investigators will additionally assess early outcome metrics including number of operative encounters.'}, {'measure': 'Percent Graft Take', 'timeFrame': 'From surgery to 9-month clinical endpoint.', 'description': 'The investigators will additionally assess early outcome metrics including percent graft take (% of surface area).'}, {'measure': 'Time to Final Healing/Graft Take', 'timeFrame': 'From surgery to 9-month clinical endpoint.', 'description': 'The investigators will additionally assess early outcome metrics including, time to final healing/graft take in days.'}, {'measure': 'Tissue Thickness', 'timeFrame': 'From surgery to 9-month clinical endpoint.', 'description': 'The investigators will measure tissue thickness as determined by ultrasound.'}, {'measure': 'Pliability (Tensiometry/Cutometry)', 'timeFrame': 'From surgery to 9-month clinical endpoint.', 'description': 'The investigators will utilize a noninvasive cutometer/tensiometer to determine tissue pliability.'}, {'measure': 'Tissue Adhesion/Mobility', 'timeFrame': 'From surgery to 9-month clinical endpoint.', 'description': 'The investigators will measure tissue mobility/resistance to adhesion under non-invasive tissue stretch.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['burns', 'scar contracture'], 'conditions': ['Burns', 'Contracture Scar', 'Surgical Injury']}, 'referencesModule': {'references': [{'pmid': '25827568', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28702187', 'type': 'BACKGROUND', 'citation': 'Simonacci 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.'}, {'pmid': '32802628', 'type': 'BACKGROUND', 'citation': 'Evans 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.'}, {'pmid': '29450855', 'type': 'BACKGROUND', 'citation': 'Woodruff 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.'}, {'pmid': '28676850', 'type': 'BACKGROUND', 'citation': 'Mokos 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.'}, {'pmid': '27707499', 'type': 'BACKGROUND', 'citation': 'Finnerty 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.'}, {'pmid': '29392092', 'type': 'BACKGROUND', 'citation': 'Marshall 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.'}, {'pmid': '20415403', 'type': 'BACKGROUND', 'citation': 'Wolf 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.'}, {'pmid': '23676968', 'type': 'BACKGROUND', 'citation': 'Harrison 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.'}, {'pmid': '29847675', 'type': 'BACKGROUND', 'citation': 'Le 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.'}, {'pmid': '35385552', 'type': 'BACKGROUND', 'citation': "D'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."}]}, 'descriptionModule': {'briefSummary': '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:\n\n\\- Can autologous layered composite grafting demonstrate non-inferiority compared to full-thickness skin grafting for delayed reconstruction of post-burn or trauma scar contracture?\n\nResearchers 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.\n\nParticipants will:\n\n* Receive fat grafting at time of scar revision.\n* Undergo simultaneous split-thickness skin grafting for full soft-tissue reconstruction.', 'detailedDescription': "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:\n\n• Demonstrate non-inferiority of autologous layered composite grafting to full-thickness skin grafting for delayed reconstruction of post-burn/trauma scar contracture.\n\nEvaluators including dedicated observers will be blinded to treatment group/strategy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The proposed study will include adult patients 18 years of age or older,\n* male or female,\n* civilian, military, active duty or retired veterans\n* presenting for scar contracture release and reconstruction at any level.\n* Additional inclusion criteria includes willingness to be randomized to receive a fat graft.\n\nExclusion Criteria:\n\n* Age \\< 18 years of age,\n* active infection,\n* medical co-morbidities or anatomic configuration deemed by the physician to be a concern for safety,\n* unwilling or unable to comply with study procedures,\n* radiation to the site of interest,\n* prisoners and/or vulnerable populations.\n* In addition, candidates that are pregnant or plan to become pregnant in the next year, will be excluded.'}, 'identificationModule': {'nctId': 'NCT06857435', 'briefTitle': 'Autologous Point-of-Care Adipose Therapy: Delayed Injury/Scar', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Autologous Point-of-Care Adipose Therapy for Reconstruction and Regeneration of Traumatized Skin: Delayed Injury/Scar', 'orgStudyIdInfo': {'id': 'STUDY24080150 - Delayed Injury'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Delayed Full Thickness Skin Graft (FTSG) Reconstruction', 'description': '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.', 'interventionNames': ['Procedure: Full Thickness Skin Graft (FTSG)']}, {'type': 'EXPERIMENTAL', 'label': 'Delayed Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Graft)', 'description': '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.', 'interventionNames': ['Procedure: Base of wound fat graft with Split Thickness Skin Graft (STSG) Reconstruction (Autologous Layered Composite Grafting).']}], 'interventions': [{'name': 'Full Thickness Skin Graft (FTSG)', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Delayed Full Thickness Skin Graft (FTSG) Reconstruction']}, {'name': 'Base of wound fat graft with Split Thickness Skin Graft (STSG) Reconstruction (Autologous Layered Composite Grafting).', 'type': 'PROCEDURE', '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 a split thickness skin graft by dermatome and applied over the layer of adipose tissue.', 'armGroupLabels': ['Delayed Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Graft)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15219', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'contacts': [{'name': 'Eleanor Shirley', 'role': 'CONTACT', 'email': 'shirleye@upmc.edu', 'phone': '412-641-8676'}, {'name': 'Francesco Egro', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mercy Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15219', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'contacts': [{'name': 'Eleanor Shirley', 'role': 'CONTACT', 'email': 'shirleye@upmc.edu', 'phone': '412-641-8676'}, {'name': 'Teun Teunis', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Presbyterian Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'centralContacts': [{'name': 'Eleanor Shirley', 'role': 'CONTACT', 'email': 'shirleye@upmc.edu', 'phone': '412-641-8676'}, {'name': 'Patsy Simon', 'role': 'CONTACT', 'email': 'simopa@UPMC.EDU', 'phone': '412-641-8676'}], 'overallOfficials': [{'name': 'Francesco Egro', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'Armed Forces Institute of Regenerative Medicine', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Burn Reconstruction', 'investigatorFullName': 'Francesco Egro', 'investigatorAffiliation': 'University of Pittsburgh'}}}}