NCT03197103

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 23, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

July 4, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

July 6, 2017

Status Verified

July 1, 2017

Enrollment Period

8 months

First QC Date

June 21, 2017

Last Update Submit

July 4, 2017

Conditions

Breast; Deformity, CongenitalGraft LossAdipose Tissue AtrophyBreast; Atrophy

Keywords

Autologous fat graftingBreastDeformityAsymmetryTuberous breastAcetylcysteine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Intraoperative complications

    During intervention (operation)

  • Postoperative complications

    6 months following the intervention

  • Immunohistochemical and genetic analysis of lipoaspirates.

    Immediately after intervention

Study Arms (2)

N-Acetylcysteine (NAC)

EXPERIMENTAL

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

Drug: N-Acetylcysteine (NAC)

Control

NO INTERVENTION

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

Interventions

N-Acetylcysteine (NAC)DRUG

For more information read Experimental Arm description

Also known as: Acetylcysteine
N-Acetylcysteine (NAC)

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Warsaw, Mazowiecki, 00416, Poland

Location

Related Publications (2)

  • 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.

    PMID: 32424535DERIVED

  • 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.

    PMID: 32221675DERIVED

MeSH Terms

Conditions

Congenital AbnormalitiesAtrophy

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Bartłomiej Noszczyk, Ph.D., M.D.

    Centre of Postgraduate Medical Education

    STUDY DIRECTOR

  • Piotr Pietruski, M.D.

    Centre of Postgraduate Medical Education

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D., M.D.

Study Record Dates

First Submitted

June 21, 2017

First Posted

June 23, 2017

Study Start

July 4, 2017

Primary Completion

March 1, 2018

Study Completion

May 1, 2018

Last Updated

July 6, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)