- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02788292
Effect of N-Acetylcysteine on Autologous Fat Graft Survival
Study Overview
Status
Intervention / Treatment
Detailed Description
Autologous fat grafting is an increasingly popular technique for soft tissue reconstruction; however, the surgical technique is limited by inconsistent graft take, undercorrection, and requirement for repeat procedures. The authors previously examined whether a widely available, clinically safe anti-oxidant, N-acetylcysteine (NAC), could improve adipose-derived stem cell survival and subsequent graft take when added to tumescent solution at the time of fat harvest in mice. The addition of NAC to tumescent fluid during fat harvest in mice protects ADSCs against oxidative stress, increases their survival and proliferation, and inhibits their early differentiation into mature adipocytes in vitro. In an in vivo model, NAC treatment at the time of harvest improved survival and quality of autologous fat grafts. These observations provide proof-of-principle for the use of NAC in the clinical setting to optimize fat graft yields.
Hypothesis: The addition of NAC to the tumescent solution used in fat grafting will improve fat graft survival in humans to potentially decrease the amount of re-operations and undercorrection that occurs.
Plan: The study will be conducted as a single-centre, randomized, triple-blind placebo-controlled trial to be performed at the QEII Health Sciences Centre, Halifax, Nova Scotia. Subjects will be chosen as healthy female patients already presenting to the operating room for elective breast reduction surgery. These patients will be enrolled and booked for surgery as they present to clinic and will not be expedited in receiving their elective surgery if enrolled in the study. Each subject will serve as her own control. The hypothesis will be tested by performing lipoaspiration of the thigh/hip region of healthy patients after the addition of tumescent solution with or without NAC. Approximately 10 millilitres of the fat graft will be injected into each pre-tibial area depending on the randomization allocation, as described by Kolle et al. (1) The volume of fat graft will be measured at 0, 1 and 3 months using computed tomographic (CT) scans according to institutional standards. The CT images will be exported into Materialise Interactive Medical Image Control System (MIMICS) and volumetric three-dimensional reconstructions will be made to measure the size and volume of the grafts at each of the time points. The grafts will then be explanted at 3 months and weighed. The histologic appearance, graded on the amount of inflammation, cysts/vacuoles, integrity and vascularity with CD31 staining will be assessed. The results will be compared using two-tailed t-tests. Statistical significance will be set at p<0.05.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Michael Bezuhly, MD
- Phone Number: (902) 470-8168
- Email: mbezuhly@dal.ca
Study Contact Backup
- Name: Joshua A Gillis, MD
- Phone Number: (902) 452-4880
- Email: jgillis@dal.ca
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women
- Desire and surgical indication for liposuction of the thigh/hip region for women already undergoing elective breast reduction surgery
- Age 18-45 years
- BMI of 20-30
- ASA Class I
Exclusion Criteria:
- Known chronic illnesses: Diabetes, HIV, renal/liver failure, metabolic disease, history of cancer or family pre-disposition of cancer, peripheral vascular disease, illness that would preclude a general anaesthetic
- Pregnancy or planned pregnancy within 1 year
- Contraindications to CT
- Previous hip/thigh surgery or injury
- Previous lower leg surgery/injury
- Smoker
- Breastfeeding
- Other disease according to investigator's judgment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acetylcysteine (NAC)
NAC added to tumescent solution for liposuction and eventual fat grafting.
|
See arm description
Other Names:
|
No Intervention: Control
Just tumescent solution for liposuction and fat grafting.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in fat graft volume over time
Time Frame: 0, 1 and 3 months
|
Based on CT scans of fat grafts and three-dimensional reconstructions/volumetric analysis
|
0, 1 and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight of fat graft
Time Frame: 3 months
|
Fat grafts will be explanted and weighed at 3 months.
|
3 months
|
Fat graft vascularity
Time Frame: 3 months
|
Vascularity of fat graft with CD31 staining.
|
3 months
|
Fat graft quality
Time Frame: 3 months
|
Quality of fat graft through histological analysis of cysts/vacuoles/intact fat cells/fibrosis and also through adipocyte slide coverage analysis.
|
3 months
|
Adverse effects or complications
Time Frame: 1 year
|
Collecting data regarding any adverse complications of the fat grafting procedure and subsequent recovery.
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NSHA-RS/2016-2961
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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