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

Graft Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03197103
• Other study ID #: 58/IX/PB/Noszczyk/16
• Status: Active, not recruiting
• Phase: Phase 4
• First received: June 21, 2017
• Last updated: July 4, 2017
• Start date: July 4, 2017
• Est. completion date: May 1, 2018

Study information

• Verified date: July 2017
• Source: Centre of Postgraduate Medical Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: May 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• N-Acetylcysteine (NAC)
For more information read Experimental Arm description

Locations

Country	Name	City	State
Poland	Centre of Postgraduate Medical Education, Prof. W. Orlowski Memorial Hospital	Warsaw	Mazowiecki

Sponsors (1)

Lead Sponsor	Collaborator
Centre of Postgraduate Medical Education

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Autologous fat graft volumetric analysis	Volumetric analysis of fat graft six months after operation (postoperative breast adipose tissue volume in comparison to preoperative volume).	6 months following the intervention in the last enrolled participant
Secondary	Intraoperative complications	Any complication that occurred during the lipofilling procedure.	During intervention (operation)
Secondary	Postoperative complications	Any complication or adverse effect of the lipofilling procedure that occurred in the six-month time frame following the operation.	6 months following the intervention
Secondary	Immunohistochemical and genetic analysis of lipoaspirates.	A 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.	Immediately after intervention