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Trial record 87 of 648 for:    NAC

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

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ClinicalTrials.gov Identifier: NCT03197103
Recruitment Status : Unknown
Verified July 2017 by Bartłomiej Noszczyk, Centre of Postgraduate Medical Education.
Recruitment status was:  Active, not recruiting
First Posted : June 23, 2017
Last Update Posted : July 6, 2017
Sponsor:
Information provided by (Responsible Party):
Bartłomiej Noszczyk, Centre of Postgraduate Medical Education

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.

Condition or disease Intervention/treatment Phase
Breast; Deformity, Congenital Graft Loss Adipose Tissue Atrophy Breast; Atrophy Drug: N-Acetylcysteine (NAC) Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Impact of N-Acetylcysteine on Volumetric Retention of Autologous Fat Graft for Breast Asymmetry Correction
Actual Study Start Date : July 4, 2017
Estimated Primary Completion Date : March 1, 2018
Estimated Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: N-Acetylcysteine (NAC)
Breast enlargement with autologous fat graft obtained by liposuction with Pietruski solution (tumescent solution with NAC).
Drug: N-Acetylcysteine (NAC)
For more information read Experimental Arm description
Other Name: Acetylcysteine

No Intervention: Control
Contralateral breast enlargement with autologous fat graft obtained by liposuction with standard tumescent solution.



Primary Outcome Measures :
  1. Autologous fat graft volumetric analysis [ Time Frame: 6 months following the intervention in the last enrolled participant ]
    Volumetric analysis of fat graft six months after operation (postoperative breast adipose tissue volume in comparison to preoperative volume).


Secondary Outcome Measures :
  1. Intraoperative complications [ Time Frame: During intervention (operation) ]
    Any complication that occurred during the lipofilling procedure.

  2. Postoperative complications [ Time Frame: 6 months following the intervention ]
    Any complication or adverse effect of the lipofilling procedure that occurred in the six-month time frame following the operation.

  3. Immunohistochemical and genetic analysis of lipoaspirates. [ Time Frame: Immediately after intervention ]
    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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03197103


Locations
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Poland
Centre of Postgraduate Medical Education, Prof. W. Orlowski Memorial Hospital
Warsaw, Mazowiecki, Poland, 00416
Sponsors and Collaborators
Centre of Postgraduate Medical Education
Investigators
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Study Director: Bartłomiej Noszczyk, Ph.D., M.D. Centre of Postgraduate Medical Education
Principal Investigator: Piotr Pietruski, M.D. Centre of Postgraduate Medical Education

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Responsible Party: Bartłomiej Noszczyk, Ph.D., M.D., Centre of Postgraduate Medical Education
ClinicalTrials.gov Identifier: NCT03197103     History of Changes
Other Study ID Numbers: 58/IX/PB/Noszczyk/16
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bartłomiej Noszczyk, Centre of Postgraduate Medical Education:
Autologous fat grafting
Breast
Deformity
Asymmetry
Tuberous breast
Acetylcysteine

Additional relevant MeSH terms:
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Acetylcysteine
N-monoacetylcystine
Atrophy
Congenital Abnormalities
Pathological Conditions, Anatomical
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes