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

Primary Purpose

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

Status
Unknown status
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
N-Acetylcysteine (NAC)
Sponsored by
Centre of Postgraduate Medical Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast; Deformity, Congenital focused on measuring Autologous fat grafting, Breast, Deformity, Asymmetry, Tuberous breast, Acetylcysteine

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre of Postgraduate Medical Education, Prof. W. Orlowski Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

N-Acetylcysteine (NAC)

Control

Arm Description

Breast enlargement with autologous fat graft obtained by liposuction with Pietruski solution (tumescent solution with NAC).

Contralateral breast enlargement with autologous fat graft obtained by liposuction with standard tumescent solution.

Outcomes

Primary Outcome Measures

Autologous fat graft volumetric analysis
Volumetric analysis of fat graft six months after operation (postoperative breast adipose tissue volume in comparison to preoperative volume).

Secondary Outcome Measures

Intraoperative complications
Any complication that occurred during the lipofilling procedure.
Postoperative complications
Any 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.
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.

Full Information

First Posted
June 21, 2017
Last Updated
July 4, 2017
Sponsor
Centre of Postgraduate Medical Education
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1. Study Identification

Unique Protocol Identification Number
NCT03197103
Brief Title
The Impact of N-Acetylcysteine on Volumetric Retention of Autologous Fat Graft for Breast Asymmetry Correction
Official Title
The Impact of N-Acetylcysteine on Volumetric Retention of Autologous Fat Graft for Breast Asymmetry Correction
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 4, 2017 (Actual)
Primary Completion Date
March 1, 2018 (Anticipated)
Study Completion Date
May 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre of Postgraduate Medical Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast; Deformity, Congenital, Graft Loss, Adipose Tissue Atrophy, Breast; Atrophy
Keywords
Autologous fat grafting, Breast, Deformity, Asymmetry, Tuberous breast, Acetylcysteine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
N-Acetylcysteine (NAC)
Arm Type
Experimental
Arm Description
Breast enlargement with autologous fat graft obtained by liposuction with Pietruski solution (tumescent solution with NAC).
Arm Title
Control
Arm Type
No Intervention
Arm Description
Contralateral breast enlargement with autologous fat graft obtained by liposuction with standard tumescent solution.
Intervention Type
Drug
Intervention Name(s)
N-Acetylcysteine (NAC)
Other Intervention Name(s)
Acetylcysteine
Intervention Description
For more information read Experimental Arm description
Primary Outcome Measure Information:
Title
Autologous fat graft volumetric analysis
Description
Volumetric analysis of fat graft six months after operation (postoperative breast adipose tissue volume in comparison to preoperative volume).
Time Frame
6 months following the intervention in the last enrolled participant
Secondary Outcome Measure Information:
Title
Intraoperative complications
Description
Any complication that occurred during the lipofilling procedure.
Time Frame
During intervention (operation)
Title
Postoperative complications
Description
Any complication or adverse effect of the lipofilling procedure that occurred in the six-month time frame following the operation.
Time Frame
6 months following the intervention
Title
Immunohistochemical and genetic analysis of lipoaspirates.
Description
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.
Time Frame
Immediately after intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bartłomiej Noszczyk, Ph.D., M.D.
Organizational Affiliation
Centre of Postgraduate Medical Education
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Piotr Pietruski, M.D.
Organizational Affiliation
Centre of Postgraduate Medical Education
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre of Postgraduate Medical Education, Prof. W. Orlowski Memorial Hospital
City
Warsaw
State/Province
Mazowiecki
ZIP/Postal Code
00416
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32424535
Citation
Pietruski P, Paskal W, Paluch L, Paskal AM, Nitek Z, Wlodarski P, Walecki J, Noszczyk B. The Impact of N-Acetylcysteine on Autologous Fat Graft: First-in-Human Pilot Study. Aesthetic Plast Surg. 2020 May 18. doi: 10.1007/s00266-020-01730-1. Online ahead of print.
Results Reference
derived
PubMed Identifier
32221675
Citation
Pietruski P, Paskal W, Paluch L, Paskal AM, Nitek Z, Wlodarski P, Walecki J, Noszczyk B. The Impact of N-Acetylcysteine on Autologous Fat Graft: First-in-Human Pilot Study. Aesthetic Plast Surg. 2021 Oct;45(5):2397-2405. doi: 10.1007/s00266-020-01633-1. Epub 2020 Mar 27.
Results Reference
derived

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

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