Trial intelligence / Profile preview

NAC-Enriched Tumescent Solution for Breast Lipofilling

NCT03197103Phase 4

Key facts

Status: Unknown
Start: Jul 2017
Primary completion: Mar 2018
Countries: 1
Sponsor: Centrum Medyczne Kształcenia Podyplomowego
Modality: Small Molecules

Drugs: acetylcysteine
Conditions: breast asymmetry

Overview

Phase 4, randomised, open-label trial of acetylcysteine in breast asymmetry (2 arms), sponsored by Centrum Medyczne Kształcenia Podyplomowego. Primary endpoint: Autologous fat graft volumetric analysis at 6 months. Status: unknown.

Design

2 arms

Study design: RandomizedOpen-label

N-Acetylcysteine (NAC)
Fat graft harvested with Pietruski solution (NAC).
Control
Fat graft harvested with standard tumescent solution.

Endpoints

Primary

Autologous fat graft volumetric analysis6 months

Secondary

Intraoperative complicationsDuring intervention
Postoperative complications6 months
Immunohistochemical and genetic analysis of lipoaspiratesImmediately after intervention

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