Robotic Harvest of the Latissimus Dorsi (LD) Muscles (NCT02274493) | Clinical Trial Compass
CompletedNot Applicable
Robotic Harvest of the Latissimus Dorsi (LD) Muscles
United States15 participantsStarted 2015-07-08
Plain-language 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 muscle below your shoulder) for reconstructive procedures.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
Number of Participants Assessed for Donor Site Complications and Muscle Flap Viability
Timeframe: Participants were followed for up to a total of 6 months post-operatively
2
Number of Participants With LD Muscle Flap Viability Following Robotic-Assisted Harvest Procedure
Timeframe: Participants were followed for up to a total of 6 months post-operatively