Autologous Fat Transfer for Scar Prevention and Remodeling

NCT01119326 | Completed Phase 1 DMC

• 1 other identifier: 503-2012
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this research study is to find out if it is safe and feasible to improve the appearance and quality of a scar by using a procedure in which adipose tissue (fat) is taken from other parts of your body and injected, or transplanted into a scar. This procedure is called autologous fat transfer (AFT). The main goal of this study is to see if AFT is safe and can improve the quality and appearance of scar tissue. Another main goal is to determine how much tissue should be transplanted to get the best results.

Conditions

Wound

Keywords

scar prevention; healing; tissue; AFT; scar analysis

Outcome Measures

Primary Outcomes (1)

• To determine the safety and feasibility of using AFT in early and delayed treatment settings to positively enhance the quality and appearance of overlying scar and to determine the safety and impact of AFT "dose" on scar quality and appearance.

  If no Dose Limiting Toxicity (DLT) is observed ,dose escalation will occur. Study sites/scars will be delineated by tracings, digital photography,scar assessment scale,and measures of scar elasticity and color. To correlate efficacy with graft quality, a sample of each adipose harvest will be sent to the laboratory for quantitative analysis of the stromal vascular fraction (SVF) with the adipose sample.

  4 times for a year

Secondary Outcomes (1)

• To determine the correlation of subjective and objective scar assessment tools for serial, prospective scar analysis.

  4 times for a year

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo procedure

Procedure: Autologous Fat Transfer

Autologous Fat Transfer (AFT) group

EXPERIMENTAL

Subjects will be registered in the context of either the Early AFT subgroup, or the Delayed AFT subgroup based on the timing of their wound closure: early AFT subgroup will contain subjects who are medically stable such that study sites are amenable to AFT within 2-4 weeks of definitive closure (STSG) or healing (secondary closure) and the delayed AFT subgroup will contain subjects who are medically stable such that study sites are amenable to AFT within 6 months or more of definitive closure (STSG) or healing (secondary closure

Procedure: Autologous Fat Transfer

Interventions

Autologous Fat Transfer PROCEDURE

one site will be treated with AFT For placebo treated (control) sites, an equal number of empty cannula passes will be administered using a similar technique described for the AFT.

Autologous Fat Transfer (AFT) group; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 2 separate (i.e. non-contiguous) wounds/scars previously healed by placement of a STSG and/or by secondary intention ("study sites"), each ≤ 50cm2 in size (area).
• o The study sites should be similar in size and anatomical location (e.g. upper arms; trunk; legs) to the extent practically possible
• Adequate adipose depot for tissue harvest
• For Early AFT Subgroup:
• o medically stable such that study sites are amenable to AFT within 2-4 weeks after definitive closure(STSG) or healing (secondary closure)
• For Delayed AFT Subgroup:
• o medically stable such that study sites are amenable to AFT at least 6 months after definitive closure(STSG) or healing (secondary closure)
• Age range: 18-65 years
• Negative pregnancy test
• Able and willing to provide verbal and written informed consent.
• Subject should begin protocol initiation within 2 weeks of being enrolled.

You may not qualify if:

• Sepsis
• Life or limb-threatening injury/disease
• Prior history of non-compliance
• Active drug use/abuse
• Active psychiatric illness
• Pregnancy
• Active cancer, or new diagnosis of cancer within the past 5 years, with the exception of basal cell and squamous cell carcinomas, as long as the subject is disease free at the time of enrollment and that the previous diagnosis was not at a site to be treated by AFT.
• History of bleeding tendency/inability to clot, and/or International normalized ratio(INR) ≥ 2.2
• Life-threatening allergic reaction to one of the medications/agents to be used in the study with no acceptable alternative/substitute identifiable
• Use of steroid injections, pressure garments, silicone sheeting or other similar scar management modalities and cannot be discontinued during study participation.
• Incarceration.
• Active duty military personnel (at UF site only)

Sponsors & Collaborators

• University of Florida: lead
• United States Department of Defense: collaborator

Study Sites (3)

University of Florida

Gainesville, Florida, 32610, United States

Location

Institute of Surgical Research (ISR)/Brooke Army Medical Center (BAMC)

Fort Sam Houston, Texas, 78234, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Adam Katz, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2010
• First Posted: May 7, 2010
• Study Start: April 1, 2010
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 21, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)