Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fat grafting | Experimental | Following liposuction the fat is decanted and used for fat grafting to the area of pain after breast cancer surgery. |
|
| Sham grafting | Sham Comparator | Following liposuction the fat is discarded. Instead approximately 50mL of saline is used instead of fat and injected into the area of pain after breast cancer surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposuction | Procedure | Liposuction is performed on the abdomen or thighs as determined before randomization by the surgeon. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain on visual analog scale (VAS) 0-10 | Pain on visual analog scale (VAS) 0-10 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropathic Pain Symptom Inventory | Questionnaire | 3 and 6 months |
| Use of pain medication | pain medication used is registered on questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Any complications following treatment | 3 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jens A Sørensen, MD PhD | Odense University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Odense | 5000 | Denmark |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015187 | Lipectomy |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
Not provided
Not provided
Not provided
Not provided
Not provided
During general anesthesia, patients are randomized to either fat grafting or sham grafting with only saline. All patients undergo the same liposuction. Participants are blinded, care providers postoperatively are blinded. The surgeon performing the procedure is not blinded. The outcome assessors 3 and 6 months postoperatively are blinded.
| Fat graft | Procedure | The harvested lipoaspirate is injected at the site of pain. |
|
|
| Sham graft (saline injection) | Procedure | Saline will be injected at the site of pain instead of fat |
|
| 3 and 6 months |
| Pain on visual analog scale (VAS) 0-10 | Pain on visual analog scale (VAS) 0-10 | 3 months |
| D000073319 |
| Obesity Management |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |