Trials / Completed
CompletedNCT01969448
Study to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction
A Prospective Randomized Trial to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 79 (actual)
- Sponsor
- Washington University School of Medicine · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The investigators hypothesize that nipple-areola skin sparing mastectomy (NASSM) performed through an inframammary incision has a superior blood supply relative to a lateral oblique incision. Moreover, by minimizing complications and optimizing aesthetic outcomes, the investigators believe it will be associated with significantly higher patient reported outcome scores. The addition of information gained by use of intraoperative laser-assisted fluorescent angiography (measured with the Spy Elite imaging device) will reduce complication rates by directing intraoperative resection of ischemic tissue and limiting the volume of immediate implant placement in instances where real time imaging would suggest compromised perfusion. These quantifiable, objective measures will justify the use of NASSM and immediate implant placement coupled with intraoperative laser-assisted fluorescent angiography in prosthetic based breast reconstruction despite longer operative times.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Inframammary Fold Incision or Lateral Radial Incision | |
| PROCEDURE | Lateral Radial Incision | |
| PROCEDURE | Inframammary Fold Incision | |
| DEVICE | Laser-assisted fluorescence angiography | |
| DRUG | Indocyanine Green |
Timeline
- Start date
- 2013-03-28
- Primary completion
- 2016-04-27
- Completion
- 2017-04-17
- First posted
- 2013-10-25
- Last updated
- 2018-04-18
- Results posted
- 2018-04-18
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT01969448. Inclusion in this directory is not an endorsement.