Robotic Harvest of the Latissimus Dorsi (LD) Muscles

Completed · Not applicable

Conditions studied: Other Reconstructive Surgery, Failure of Muscle Graft, Cancer, Complications, Surgical Procedure, Unspecified

In brief

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 muscle below your shoulder) for reconstructive procedures.

Key facts

Study ID

NCT02274493

Run by

M.D. Anderson Cancer Center

People needed

15

Starts

2015-07-08

Expected to finish

2018-03-07

Last updated by the study team

2019-03-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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