Viewing Study NCT02976103


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Study NCT ID: NCT02976103
Status: COMPLETED
Last Update Posted: 2020-03-12
First Post: 2016-11-18
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: Reduction of Post Mastectomy Pain With the Jacki® Recovery Jacket
Sponsor: Dana-Farber Cancer Institute
Organization:

Study Overview

Official Title: Reduction of Post Mastectomy Pain With the Jacki® Recovery Jacket: Randomized Trial
Status: COMPLETED
Status Verified Date: 2020-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This research study is studying a garment called the Jacki® recovery jacket that can be worn after surgery as a possible way to manage pain from surgical drains.

The study intervention involved in this study is:

-"Jacki" recovery jacket
Detailed Description: In this research study, the investigators are studying the Jacki, a garment that can be worn post-mastectomy with pockets that hold post-surgical drains. The Jacki was invented by a cancer survivor who leads A Little Easier Recovery®, a non-profit organization in Massachusetts, and may help participants manage the pain of post-surgical drains to increase comfort and ease of daily living. The jacket has not previously been tested in a research study. The investigators are hoping to learn whether the jacket is effective in reducing pain and discomfort from the time participants leave the hospital until they return to have their drains removed.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: True
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: