Wound of SkinNCT03548610
Efficacy and Safety of a Nanofat-seeded Biological Scaffold in Healing Lower Limb Surgical Defects
A study testing Nanofat-seeded biological scaffold on surgical defect in people with Wound of Skin and Non-melanoma Skin Cancer, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wound of Skin, Non-melanoma Skin Cancer, Skin Graft Complications
- What is being tested?
- Nanofat-seeded biological scaffold on surgical defect
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2019to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age less than 18 years of age
- Pregnant women
- Any contraindications to use of nanofat or collagen scaffold
Trial locations and contacts
1 site in 1 country.
United States1 site
Mohs and Dermatologic Surgery Center, Brigham and Women's Hospital
Boston, Massachusetts, 02130
About this study
Official title: Efficacy and Safety of a Nanofat-seeded Biological Scaffold in Healing Lower Limb Surgical Defects: A Randomized, Controlled Study
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.
Read the detailed description
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. To overcome these limitations, cultured epidermal autografts consisting of keratinocytes were developed to provide enough autologous skin. However, the routine use of these cultured epidermal autografts was hampered by its high risk of recurrent wound opening, long-term fragility, and increased rates of scar contractures.
Tissue-engineered dermal skin substitutes containing complex dermal layers have also been developed to produce large, near-natural skin substitutes. They promote healing and avoid scar contracture; however, the healing times are long as they lack the active cellular and paracrine components of healing, and they often need a second delayed surgical procedure, a split-thickness skin graft, to obtain complete epithelization.
The term "nanofat grafting" was first used by Tonnard et al. and constitutes a rich reservoir of regenerative precursor cells (including stromal vascular fraction cells, among which adipose-derived stem cells) with pro-angiogenic capabilities. The many proprieties of nanofat and the stromal vascular fraction in regenerative and aesthetic surgery are just being discovered. In particular, numerous in vitro and in vivo studies have demonstrated the ability of these cells to differentiate into various skin cell lineages. Moreover, they are recognized as a powerful source for tissue regeneration because of their capability to secrete paracrine factors, initiating tissue repair and accelerating wound closure by skin regeneration instead of fibrotic scar formation.
Few anecdotal reports have documented the efficacy of the stromal vascular fraction in acute as well as chronic wounds. However, no observation has explored the efficacy of nanofat in healing surgical defects. Of note, nanofat is substantially easier, faster, and remarkably less expensive to obtain when compared to the mechanically- or enzymatically-isolated stromal vascular fraction. At present, there is a noticeable lack of randomized-controlled evidence in the international literature. Thus, this would represent the most comprehensive and the first randomized, controlled experience documenting the use of nanofat for wound healing.
- Conditions
- Wound of Skin, Non-melanoma Skin Cancer, Skin Graft Complications, Wound of Lower Leg, Wound of Knee
- Being tested
- Nanofat-seeded biological scaffold on surgical defect
- Keywords
- nanofat, tumor defect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanofat-seeded biological scaffold on surgical defectOther
Nanofat-seeded biological scaffold in healing larger surgical defects (>1.5cm) involving the lower limbs
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Histogram planimetry is a way to objectively assess wound area changes over time. It is based on the pixel count of a selected irregular area which is divided by the pixel count of 1cm^2 to find a result in terms of cm^2 or mm^2
Measured: 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
A physician blinded to the treatment group the subject is in will self-administer the Vancouver Scar Scale (VSS) which documents change in scar appearance over time. The VSS ranges from 0 (most desirable outcome) to 13 (least desirable outcome), thus, a lower score is considered to have a better outcome and a higher score is considered a worse outcome. The VSS consists of four sub-scales, with each sub-scale reporting a value. The "pigmentation sub-scale" ranges from 0 (normal pigmentation) to 2 (hyperpigmentation); the "vascularity sub-scale" ranges from 0 (normal appearance) to 3 (purple appearance); the "pliability sub-scale" ranges from 0 (normal pliability) to 5 (contracture); and the "height sub-scale" ranges from 0 (normal [flat]) to 3 (>5mm). Sub-scale scores are totaled to give an overall VSS assessment score.
Measured: 3 months' post-surgery, 6 months' post-surgery
Study subject completes the Patient Scar Assessment Scale
Subjects will be asked to complete a Visual Analogue Scale (Patient Scar Assessment Scale, PSAS) for scar assessment to rate how they think their wound site appears cosmetically compared to normal skin, and any complaints about how painful the site is, and how itchy it feels. Each question ranges from 1 (no complaints with itch or pain/as normal skin) to 10 (worst imaginable itch or pain/very different from normal skin). The PSAS ranges from 6 (best outcome score) to 66 (worst outcome score), thus a lower score is considered to have a better outcome and a higher score is considered a worse outcome.
Measured: 3 months' post-surgery, 6 months' post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study start30 Jan 2019
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Why it stopped: None of the screened subjects were interested / eligible for enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Wound of SkinStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abigail Waldman,M.D., Brigham and Women's Hospital
- Investigators
- Chrysalyne D Schmults, MD, MSCE, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03548610
- Sponsor's protocol ID
- 2018P001086
- Status last verified
- Feb 2020
- First submitted
- 17 May 2018
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28337463Tonnard 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.
PubMed 23783059Cervelli 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.
PubMed 21195687You 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.
PubMed 24616577Konstantinow 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.
PubMed 28750144Brett 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.
PubMed 28372485Klinger 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.
PubMed 26545361Uyulmaz 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.
PubMed 29365061
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Nanofat-seeded Biological Scaffold in Healing Lower Limb Surgical Defects: A Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT03548610
- Acronym / sponsor ID
- 2018P001086
- Conditions
- Wound of Skin, Non-melanoma Skin Cancer, Skin Graft Complications, Wound of Lower Leg, Wound of Knee
- Keywords
- nanofat, tumor defect
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: None of the screened subjects were interested / eligible for enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 7 Jun 2018 (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.
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.
Detailed description
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. To overcome these limitations, cultured epidermal autografts consisting of keratinocytes were developed to provide enough autologous skin. However, the routine use of these cultured epidermal autografts was hampered by its high risk of recurrent wound opening, long-term fragility, and increased rates of scar contractures.
Tissue-engineered dermal skin substitutes containing complex dermal layers have also been developed to produce large, near-natural skin substitutes. They promote healing and avoid scar contracture; however, the healing times are long as they lack the active cellular and paracrine components of healing, and they often need a second delayed surgical procedure, a split-thickness skin graft, to obtain complete epithelization.
The term "nanofat grafting" was first used by Tonnard et al. and constitutes a rich reservoir of regenerative precursor cells (including stromal vascular fraction cells, among which adipose-derived stem cells) with pro-angiogenic capabilities. The many proprieties of nanofat and the stromal vascular fraction in regenerative and aesthetic surgery are just being discovered. In particular, numerous in vitro and in vivo studies have demonstrated the ability of these cells to differentiate into various skin cell lineages. Moreover, they are recognized as a powerful source for tissue regeneration because of their capability to secrete paracrine factors, initiating tissue repair and accelerating wound closure by skin regeneration instead of fibrotic scar formation.
Few anecdotal reports have documented the efficacy of the stromal vascular fraction in acute as well as chronic wounds. However, no observation has explored the efficacy of nanofat in healing surgical defects. Of note, nanofat is substantially easier, faster, and remarkably less expensive to obtain when compared to the mechanically- or enzymatically-isolated stromal vascular fraction. At present, there is a noticeable lack of randomized-controlled evidence in the international literature. Thus, this would represent the most comprehensive and the first randomized, controlled experience documenting the use of nanofat for wound healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model 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 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.
| Arm | Type | Receives |
|---|---|---|
| Nanofat-seeded biological scaffold on surgical defect | Experimental | Other: Nanofat-seeded biological scaffold on surgical defectNanofat 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Age less than 18 years of age
- Pregnant women
- Any contraindications to use of nanofat or collagen scaffold
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 |
|---|---|---|
| Nanofat-seeded biological scaffold on surgical defectNanofat-seeded biological scaffold in healing larger surgical defects (>1.5cm) involving the lower limbs | Other | Nanofat-seeded biological scaffold on surgical defect |
Primary outcome
Change in healing response to treatment (>95% healed in surface by physician assessment)
Time frame: 7 days post-surgery, 15 days post-surgery, 30 days post-surgery, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery
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.
3 secondary outcomes
Change in histogram planimetry for surgical site
Time frame: 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
Time frame: 3 months' post-surgery, 6 months' post-surgery
Study subject completes the Patient Scar Assessment Scale
Time frame: 3 months' post-surgery, 6 months' post-surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Background: PubMed 28337463Klar 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.
- Background: PubMed 23783059Tonnard 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.
- Background: PubMed 21195687Cervelli 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.
- Background: PubMed 24616577You 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.
- Background: PubMed 28750144Konstantinow 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.
- Background: PubMed 28372485Brett 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.
- Background: PubMed 26545361Klinger 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.
- Background: PubMed 29365061Uyulmaz 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.
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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. This study is not recruiting at the moment.
Chrysalyne D Schmults, MD, MSCE principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nanofat-seeded biological scaffold on surgical defect in people with Wound of Skin and Non-melanoma Skin Cancer, run by Brigham and Women's Hospital at 1 site 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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in healing response to treatment (>95% healed in surface by physician assessment) (time frame: 7 days post-surgery, 15 days post-surgery, 30 days post-surgery, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery). 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 NCT03548610, which also lists 8 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 11 Feb 2020; AzTrials last refreshed its copy on 8 Nov 2026.