Trial Outcomes & Findings for Robotic Harvest of the Latissimus Dorsi (LD) Muscles (NCT NCT02274493)

NCT ID: NCT02274493

Last Updated: 2019-03-26

Results Overview

Muscle flap viability was determined by measuring the blood flow into and out of the muscle flap with a hand held Doppler after muscle harvest was complete

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: Participants were followed for up to a total of 6 months post-operatively
• Results posted on: 2019-03-26

Participant Flow

Participant milestones

Measure	Latissimus Dorsi Muscle Harvest Latissimus dorsi muscle harvest using the DaVinci robotic approach
Overall Study STARTED	15
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Latissimus Dorsi Muscle Harvest Latissimus dorsi muscle harvest using the DaVinci robotic approach
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Robotic Harvest of the Latissimus Dorsi (LD) Muscles

Baseline characteristics by cohort

Measure	Latissimus Dorsi Muscle Harvest n=15 Participants Latissimus dorsi muscle harvest using the DaVinci robotic approach
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	49.2 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants
Latissimus dorsi muscle function	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: Participants were followed for up to a total of 6 months post-operatively

Population: All participants were assessed for the primary measure

Muscle flap viability was determined by measuring the blood flow into and out of the muscle flap with a hand held Doppler after muscle harvest was complete

Outcome measures

Measure	Latissimus Dorsi Muscle Harvest n=15 Participants Latissimus dorsi muscle harvest using the DaVinci robotic approach
Number of Participants Assessed for Donor Site Complications and Muscle Flap Viability	15 Participants

PRIMARY outcome

Timeframe: Participants were followed for up to a total of 6 months post-operatively

Outcome measures

Measure	Latissimus Dorsi Muscle Harvest n=15 Participants Latissimus dorsi muscle harvest using the DaVinci robotic approach
Number of Participants With LD Muscle Flap Viability Following Robotic-Assisted Harvest Procedure	15 Participants

SECONDARY outcome

Timeframe: Participants were followed for up to a total of 6 months post-operatively

Population: 1 participant withdrew study consent prior to post-procedure follow up visits.

The participants listed were evaluated for donor site complication.

Outcome measures

Measure	Latissimus Dorsi Muscle Harvest n=15 Participants Latissimus dorsi muscle harvest using the DaVinci robotic approach
Evaluation of Donor Site Complications Through 6 Months Post-procedure	14 Participants

SECONDARY outcome

Timeframe: Participants were followed for up to a total of 6 months post-operatively

Population: 1 participant withdrew study consent prior to post-procedure follow up visits.

Flap failure is defined as irreversible arterial and venous thrombosis detected by implantable or surface doppler signal.

Outcome measures

Measure	Latissimus Dorsi Muscle Harvest n=15 Participants Latissimus dorsi muscle harvest using the DaVinci robotic approach
LD Muscle Flap Failure Through 6 Months Post-procedure	0 Participants

Adverse Events

Latissimus Dorsi Muscle Harvest

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Latissimus Dorsi Muscle Harvest n=15 participants at risk Latissimus dorsi muscle harvest using the DaVinci robotic approach
Infections and infestations Infection	6.7% 1/15 • Subjects were followed for a total of 6 months post-operatively

Other adverse events

Measure	Latissimus Dorsi Muscle Harvest n=15 participants at risk Latissimus dorsi muscle harvest using the DaVinci robotic approach
Infections and infestations Infection	6.7% 1/15 • Subjects were followed for a total of 6 months post-operatively
Musculoskeletal and connective tissue disorders Seroma	6.7% 1/15 • Subjects were followed for a total of 6 months post-operatively

Additional Information

Dr. Jesse C Selber / Professor, Plastic Surgery

UT MD Anderson Cancer Center

Phone: 713-794-1297

Email: jcselber@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place