Effect of N-Acetylcysteine on Autologous Fat Graft Survival

NCT02788292 | Withdrawn Phase 4

• 1 other identifier: 1021326
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

A single-centre triple-blind study looking at the addition of NAC to tumescent solution for liposuction and fat grafting in healthy patient volunteers already undergoing bilateral breast reduction. Three-dimensional reconstructions and volumetric analysis will be performed based on CT scans at 0, 1 and 3 months and then histological analysis will be performed after fat graft explantation at 3 months to determine fat graft vascularity and quality.

Conditions

Adipose Tissue Atrophy; Deformity of Reconstructed Breast; Graft Loss

Keywords

acetylcysteine; three-dimensional reconstruction; autologous fat grafting

Outcome Measures

Primary Outcomes (1)

• Change in fat graft volume over time

  Based on CT scans of fat grafts and three-dimensional reconstructions/volumetric analysis

  0, 1 and 3 months

Secondary Outcomes (4)

• Weight of fat graft

  3 months

• Fat graft vascularity

  3 months

• Fat graft quality

  3 months

• Adverse effects or complications

  1 year

Study Arms (2)

Acetylcysteine (NAC)

EXPERIMENTAL

NAC added to tumescent solution for liposuction and eventual fat grafting.

Drug: Acetylcysteine

Control

NO INTERVENTION

Just tumescent solution for liposuction and fat grafting.

Interventions

Acetylcysteine DRUG

See arm description

Also known as: N-acetylcysteine

Acetylcysteine (NAC)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women
• Desire and surgical indication for liposuction of the thigh/hip region for women already undergoing elective breast reduction surgery
• Age 18-45 years
• BMI of 20-30
• ASA Class I

You may not qualify if:

• Known chronic illnesses: Diabetes, HIV, renal/liver failure, metabolic disease, history of cancer or family pre-disposition of cancer, peripheral vascular disease, illness that would preclude a general anaesthetic
• Pregnancy or planned pregnancy within 1 year
• Contraindications to CT
• Previous hip/thigh surgery or injury
• Previous lower leg surgery/injury
• Smoker
• Breastfeeding
• Other disease according to investigator's judgment

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

MeSH Terms

Interventions

Acetylcysteine

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

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: SPONSOR

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: June 2, 2016
• Study Start: August 15, 2016
• Primary Completion: November 16, 2020
• Study Completion: November 16, 2020
• Last Updated: August 21, 2024

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share