CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 5 enrolled
Drug / intervention
Insertion of Tissue Expander with Fluid Reservoirdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03784859
NCT03784859N/ACompleted

Tissue Expansion in Breast Reconstruction Without Drains: A Study Using a Tissue Expander That Collects Periprosthetic Fluid

Cedars-Sinai Medical Center·observational·Posted Dec 24, 2018·Updated Oct 6, 2020

In Brief

An observational study evaluating Insertion of Tissue Expander with Fluid Reservoir for Breast Cancer and 2 related conditions. Completed, enrolled 5 participants across 1 site.

Detailed Summary

The primary objective of this small feasibility pilot study is to demonstrate that implant-based breast reconstruction (after treatment for cancer) can successfully be performed without prolonged drain placement, using a tissue expander with a reservoir and in-office transcutaneous fluid aspiration. Secondly, the investigators aim to provide enough confidence in this technique that a larger study can be performed to demonstrate fewer complications (infection, drain-related pain and re-operation rates) when compared to the use of conventional tissue expanders and/or implants with prolonged drain placement.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedDec 24, 2018
Enrollment StartFeb 25, 2019
Primary CompletionJul 13, 2020
Study CompletionOct 2, 2020
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 7.5 years ago

Interventions

Insertion of Tissue Expander with Fluid Reservoirdevice

Use of unique expander type in first stage of a two-stage breast reconstruction, without prolonged drain placement.