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The Impact of N-Acetylcysteine on Volumetric Retention of Autologous Fat Graft for Breast Asymmetry Correction

The Impact of N-Acetylcysteine on Volumetric Retention of Autologous Fat Graft for Breast Asymmetry Correction

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03197103
Enrollment
15
Registered
2017-06-23
Start date
2017-07-04
Completion date
2018-05-01
Last updated
2017-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adipose Tissue Atrophy, Breast; Atrophy, Breast; Deformity, Congenital, Graft Loss

Keywords

Autologous fat grafting, Breast, Deformity, Asymmetry, Tuberous breast, Acetylcysteine

Brief summary

The aim of this study is to assess the effect of new tumescent solution for liposuction containing N-Acetylcysteine (Pietruski solution) on the autologous fat graft volumetric retention used for healthy women breast asymmetry correction by means of lipofilling.

Detailed description

Lipofilling is the process of relocating autologous fat to change the volume, shape, and profile of tissues. It is considered a simple, inexpensive and minimally invasive technique indicated for both congenital and acquired soft tissue defects in many sites. Success is heavily dependent on the harvesting technique, preparing and injection of the fat. The main limitation of the abovementioned surgical procedure is a loss of transplanted adipose tissue which is believed to be caused mainly by cells injury in oxidative, ischemic, and mechanical stress mechanism. High graft resorption rate results in undercorrection and requirement for multiple-stage treatment. The aim of this study is to assess the effect of new tumescent solution for liposuction containing N-Acetylcysteine (NAC) on the autologous fat graft volumetric retention used for healthy women breast asymmetry correction by means of lipofilling. NAC reduces free radicals using a sulfhydryl chemical group. In authors opinion, this antioxidant effect may decrease oxidative stress experienced by adipose graft cells during the harvest procedure, therefore potentially improving the long-term survivability of the fat graft, lowering the number of re-operations and even maybe the total volume of fat graft needed to achieve satisfactory results. The results of this study may justify the usage of novel tumescent solution (Pietruski solution) for autologous adipose tissue graft harvest in the routine clinical setting. The subjects for this project will consist of the group of women who are candidates for hypoplastic, asymmetric breasts correction with at least two-staged lipofilling procedure. The bilateral character of such defect allows for each patient to serve as her own control. In the first lipofilling procedure one breast will be enlarged with autologous fat graft harvested from one thigh region after its infiltration with Pietruski solution. The contralateral breast will be enlarged with adipose tissue collected from contralateral thigh area by performing lipoaspiration after standard tumescent solution infiltration. Only the first stage of breasts defect correction is included in this study. Additional, future lipofilling procedures will utilize fat graft obtained with a standard tumescent solution only. The hypothesis that addition of NAC to the tumescent solution used for the fat graft harvest procedure will decrease its long-term resorption in breast region will be tested in comparison to the fat graft obtained with liposuction using standard tumescent solution. For each subject, a breast magnetic resonance imaging (MRI) will be performed before and six months after the first fat graft transfer enabling quantitative, volumetric analysis of the transplanted adipose tissue resorption. In addition, a volume of 50 ml of each harvested fat graft will be intended for genetic and immunohistochemical analysis. The results will be compared using two-tailed t-tests with statistical significance set at p\<0.05. The study will be conducted at the Plastic Surgery Department, Centre of Postgraduate Medical Education, Warsaw, Poland.

Interventions

DRUGN-Acetylcysteine (NAC)

For more information read Experimental Arm description

Sponsors

Centre of Postgraduate Medical Education
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* Female * Age 18-40 years * BMI \> 20 * Breasts asymmetry (including tuberous breasts deformity) with indications for treatment with autologous fat grafting * ASA PS I

Exclusion criteria

* Asthma * A history of allergic reaction to NAC * Peptic ulcer disease * Contraindications to MRI imaging * A history of breast surgery or radiotherapy * A history of hip/thigh surgery or injury * Breastfeeding, pregnancy or planned pregnancy within a year * Ilness or general state of health precluding general anesthesia

Design outcomes

Primary

MeasureTime frameDescription
Autologous fat graft volumetric analysis6 months following the intervention in the last enrolled participantVolumetric analysis of fat graft six months after operation (postoperative breast adipose tissue volume in comparison to preoperative volume).

Secondary

MeasureTime frameDescription
Intraoperative complicationsDuring intervention (operation)Any complication that occurred during the lipofilling procedure.
Postoperative complications6 months following the interventionAny complication or adverse effect of the lipofilling procedure that occurred in the six-month time frame following the operation.
Immunohistochemical and genetic analysis of lipoaspirates.Immediately after interventionA volume of at least 50 ml of each harvested fat graft (control tumescent solution vs Pietruski tumescent solution) will be intended for genetic and immunohistochemical analysis. The immediate analysis will include oxidative stress markers quantification (Nitric Oxide, Superoxide dismutase, Reactive Oxygen Species), dead cell count evaluation (flow cytometry) and RNA isolation for the future qRT-PCR analysis of chosen targets expression related to cells' stress response. Additional, an attempt will be taken to isolate adipose-derived stem cells (ASC) from each lipoaspirate for the purpose of hydrogen peroxide exposure test, ELISA test, flow cytometry, Colony Forming Unit-Fibroblastic Assay (CFU-F) and Cell Proliferation Assay.

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026