Status:
COMPLETED
Robotic Harvest of the Latissimus Dorsi (LD) Muscles
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Other Reconstructive Surgery
Failure of Muscle Graft
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical research study is to learn more about the safety and feasibility of using the Da Vinci Robotic Surgical system in procedures that harvest the latissimus dorsi muscle (a back ...
Detailed Description
If participant is found to be eligible to take part in this study, and participant agrees, participant's screening, reconstructive surgery, and follow-up appointments will be scheduled over multiple v...
Eligibility Criteria
Inclusion
- The subject must be equal to or greater than 18 years of age.
- The subject must be willing and able to provide informed consent.
- The subject is willing and able to comply with the study protocol.
- The subject is undergoing one of the following reconstructive procedures that requires latissimus dorsi muscle harvest: a. Post-mastectomy breast reconstruction procedure (either nipple or skin sparing) in which a female subject needs additional muscle coverage over an implant, but does not need additional skin (i.e., patient is a candidate for a pedicled latissimus dorsi muscle flap procedure); b. Scalp reconstruction procedure in which the subject needs a free latissimus dorsi muscle flap for wound coverage; c. Upper extremity reconstruction procedure in which the subject needs a free latissimus dorsi muscle flap for wound coverage; or, d. Lower extremity reconstruction procedure in which the subject needs a free latissimus dorsi muscle flap for wound coverage.
- The subject agrees to follow-up examinations out to 6 months post-treatment.
Exclusion
- The subject has a BMI \> 35.
- The subject has a history of significant bleeding disorders.
- The subject is diabetic.
- The subject is known or suspected to be pregnant or lactating.
- The subject has a history of peripheral vascular disease.
- The subject is a current smoker (has smoked within 4 weeks prior to surgery).
- The subject has had prior back or axillary surgeries which could compromise the blood supply of the flap.
Key Trial Info
Start Date :
July 8 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2018
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02274493
Start Date
July 8 2015
End Date
March 7 2018
Last Update
March 26 2019
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030