Efficacy and Safety of a Nanofat-seeded Biological Scaffold in Healing Lower Limb Surgical Defects

NCT03548610 | Withdrawn

• 1 other identifier: 2018P001086
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Wound of Skin; Non-melanoma Skin Cancer; Skin Graft Complications; Wound of Lower Leg; Wound of Knee

Keywords

nanofat; tumor defect

Outcome Measures

Primary Outcomes (1)

• Change in healing response to treatment (>95% healed in surface by physician assessment)

  A blinded study physician will assess the healing surface area at each visit. A wound is considered "healed" when the wound has healed \>95% in surface by the physician assessment. Wounds in the intervention group are expected to have faster healing compared to the standard of care group.

  7 days post-surgery, 15 days post-surgery, 30 days post-surgery, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery

Secondary Outcomes (3)

• Change in histogram planimetry for surgical site

  7 days' post-surgery, 15 days' post-surgery, 30 days' post-surgery, 3 months' post-surgery, 6 months' post-surgery, 12 months' post-surgery

• Cosmetic outcomes of surgical site by blinded physician Vancouver Scar Scale assessment

  3 months' post-surgery, 6 months' post-surgery

• Study subject completes the Patient Scar Assessment Scale

  3 months' post-surgery, 6 months' post-surgery

Study Arms (2)

Nanofat-seeded biological scaffold on surgical defect

EXPERIMENTAL

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.

Other: Nanofat-seeded biological scaffold on surgical defect

Standard of Care dressings

NO INTERVENTION

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.

Interventions

Nanofat-seeded biological scaffold on surgical defect OTHER

Nanofat-seeded biological scaffold in healing larger surgical defects (\>1.5cm) involving the lower limbs

Nanofat-seeded biological scaffold on surgical defect

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age less than 18 years of age
• Pregnant women
• Any contraindications to use of nanofat or collagen scaffold

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Mohs and Dermatologic Surgery Center, Brigham and Women's Hospital

Boston, Massachusetts, 02130, United States

Location

Related Publications (8)

• Klar 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 BACKGROUND

• Tonnard 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 BACKGROUND

• Cervelli 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 BACKGROUND

• You 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 BACKGROUND

• Konstantinow 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 BACKGROUND

• Brett 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 BACKGROUND

• Klinger 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.

  PMID: 26545361 BACKGROUND

• Uyulmaz S, Sanchez Macedo N, Rezaeian F, Giovanoli P, Lindenblatt N. Nanofat Grafting for Scar Treatment and Skin Quality Improvement. Aesthet Surg J. 2018 Mar 14;38(4):421-428. doi: 10.1093/asj/sjx183.

  PMID: 29365061 BACKGROUND

Study Officials

• Chrysalyne D Schmults, MD, MSCE

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded physician will evaluate standardized photographs.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MOHS Physician

Model Details: 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 the 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.

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: June 7, 2018
• Study Start: January 30, 2019
• Primary Completion: March 31, 2021
• Study Completion: July 31, 2021
• Last Updated: February 11, 2020

Record last verified: 2020-02

Locations

US (1)