Clinical trial · Interventional
Efficacy and Safety of a Nanofat-seeded Biological Scaffold in Healing Lower Limb Surgical Defects
Efficacy and Safety of a Nanofat-seeded Biological Scaffold in Healing Lower Limb Surgical Defects: A Randomized, Controlled Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): None of the screened subjects were interested / eligible for enrollment.
Summary
Brief summary (as posted)
Large full-thickness skin defects, such as those resulting from trauma, large and giant congenital nevi, disfiguring scars, or tumor resection remain major clinical problems to patients and physicians. Skin flaps and grafts represent the current standard of care (SOC), but often present limitations associated with surgical morbidity and donor site availability. The investigators will enroll 64 patients who have their skin cancer surgically removed and require reconstructive procedure such as a skin flap/graft. To objective of this study is to assess the efficacy and safety of a nanofat-seeded biological scaffold versus the SOC in healing larger surgical defects (\>1.5cm) involving the lower limb that cannot be closed by direct suture and thus need a reconstructive procedure such as a skin flap/graft.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-melanoma Skin Cancer | Skin Carcinoma | ALIAS | 0.90 |
| Skin Graft Complications | — | UNRESOLVED | — |
| Wound of Knee | — | UNRESOLVED | — |
| Wound of Lower Leg | — | UNRESOLVED | — |
| Wound of Skin | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nanofat-seeded biological scaffold on surgical defect | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nanofat-seeded biological scaffold on surgical defect
- description
- Nanofat is obtained via lipoaspiration of 10cc of fat from abdomen under moderate local tumescent anesthesia w/ saline. Cannula access point is anesthetized by local lidocaine infiltration. Lipoaspirate is processed into nanofat using the Tonnard method, after 3-minute decantation. Aspiration is performed using a multihole 3mm cannula. Wound margin + bed is treated w/ topical \& local injections of nanofat, then covered w/ a biological scaffold, the inferior surface of which is soaked in nanofat; scaffold is fixed w/ external dressings or resorbable sutures; external covering includes polyurethane film \& 3 layers of dressings. Topical application creates a fine \<1mm nanofat layer. Scaffold (Puracol Plus) is left in place to integrate w/ surrounding skin, while external dressings changed at 7 \& 15 days. Lipoaspirate donor site needs mild to moderate compression for 24 hours \& suture removal (if not absorbed) at 7 days.
- interventionNames
- Other: Nanofat-seeded biological scaffold on surgical defect
- type
- NO_INTERVENTION
- label
- Standard of Care dressings
- description
- Immediately after surgical resection, each patient will be treated following the SOC, therefore with a local skin flap, rather than with a skin graft, based on surgeon assessment. Sutures, and moulage, if present, will be removed at 7 days and patient instructed to apply a daily silicone cream and sunscreen for 2 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects who need to undergo a surgical intervention resulting in complex lower limb surgical defects that cannot be closed primarily, and thus need a reconstructive phase * Willing to undertake all study procedures, including nanofat harvesting from stomach site * Willing to sign an informed consent form Exclusion Criteria: * Age less than 18 years of age * Pregnant women * Any contraindications to use of nanofat or collagen scaffold
References
Publications (8)
- BACKGROUNDKlar AS, Zimoch J, Biedermann T. Skin Tissue Engineering: Application of Adipose-Derived Stem Cells. Biomed Res Int. 2017;2017:9747010. doi: 10.1155/2017/9747010. Epub 2017 Feb 27. PMID 28337463
- BACKGROUNDTonnard P, Verpaele A, Peeters G, Hamdi M, Cornelissen M, Declercq H. Nanofat grafting: basic research and clinical applications. Plast Reconstr Surg. 2013 Oct;132(4):1017-1026. doi: 10.1097/PRS.0b013e31829fe1b0. PMID 23783059
- BACKGROUNDCervelli V, Gentile P, De Angelis B, Calabrese C, Di Stefani A, Scioli MG, Curcio BC, Felici M, Orlandi A. Application of enhanced stromal vascular fraction and fat grafting mixed with PRP in post-traumatic lower extremity ulcers. Stem Cell Res. 2011 Mar;6(2):103-11. doi: 10.1016/j.scr.2010.11.003. Epub 2010 Nov 30. PMID 21195687
- BACKGROUNDYou HJ, Han SK. Cell therapy for wound healing. J Korean Med Sci. 2014 Mar;29(3):311-9. doi: 10.3346/jkms.2014.29.3.311. Epub 2014 Feb 27. PMID 24616577
- BACKGROUNDKonstantinow A, Arnold A, Djabali K, Kempf W, Gutermuth J, Fischer T, Biedermann T. Therapy of ulcus cruris of venous and mixed venous arterial origin with autologous, adult, native progenitor cells from subcutaneous adipose tissue: a prospective clinical pilot study. J Eur Acad Dermatol Venereol. 2017 Dec;31(12):2104-2118. doi: 10.1111/jdv.14489. Epub 2017 Sep 4. PMID 28750144
- BACKGROUNDBrett E, Chung N, Leavitt WT, Momeni A, Longaker MT, Wan DC. A Review of Cell-Based Strategies for Soft Tissue Reconstruction. Tissue Eng Part B Rev. 2017 Aug;23(4):336-346. doi: 10.1089/ten.TEB.2016.0455. Epub 2017 Apr 27. PMID 28372485
- BACKGROUNDKlinger A, Kawata M, Villalobos M, Jones RB, Pike S, Wu N, Chang S, Zhang P, DiMuzio P, Vernengo J, Benvenuto P, Goldfarb RD, Hunter K, Liu Y, Carpenter JP, Tulenko TN. Living scaffolds: surgical repair using scaffolds seeded with human adipose-derived stem cells. Hernia. 2016 Feb;20(1):161-70. doi: 10.1007/s10029-015-1415-0. Epub 2015 Nov 6.