NCT03081286

Treatment of Postmastectomy Pain Syndrome With Fat Grafting

Treatment of Postmastectomy Pain Syndrome With Fat Grafting: A Double-blinded Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the possible beneficial effect of fat grafting for post mastectomy pain syndrome. Half of patients will receive fat grafting and the other half of patients will receive sham.

Detailed description

Several studies have suggested that fat grafting can alleviate pain in post mastectomy pain syndrome. These studies however have either been in the form of case series or unblinded studies with great risk of bias. It is believed that fat grafting with its content of adipose-derived stem cells can modulate the scar tissue upon grafting and hereby decrease pain. In this study patients will be randomized to either fat grafting or a sham procedure where they undergo the same liposuction but no fat grafting, only injection of saline instead of fat.

Conditions

• Post-Mastectomy Chronic Pain Syndrome (Disorder)

Interventions

Type	Name	Description
PROCEDURE	Liposuction	Liposuction is performed on the abdomen or thighs as determined before randomization by the surgeon.
PROCEDURE	Fat graft	The harvested lipoaspirate is injected at the site of pain.
PROCEDURE	Sham graft (saline injection)	Saline will be injected at the site of pain instead of fat

Timeline

• Start date: 2017-08-01
• Primary completion: 2020-07-31
• Completion: 2020-07-31
• First posted: 2017-03-16
• Last updated: 2020-09-16

Locations

1 site across 1 country: Denmark