NCT02976103

Reduction of Post Mastectomy Pain With the Jacki® Recovery Jacket

Reduction of Post Mastectomy Pain With the Jacki® Recovery Jacket: Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mastectomy

Interventions

Type	Name	Description
DEVICE	Jacki Recovery jacket	An outer jacket that holds surgical drains and allows access for blood draws
OTHER	Standard Care Pain medicine/management	Standard care pain medicine and management in hospitals where the study enrolls

Timeline

• Start date: 2017-03-07
• Primary completion: 2018-01-11
• Completion: 2018-01-11
• First posted: 2016-11-29
• Last updated: 2020-03-12
• Results posted: 2020-03-12

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study