Surgical harvesting of the Latissimus Dorsi (LD) Muscles using da Vinci® robotic surgical system in participants undergoing LD muscle flap harvest procedures in conjunction with breast, scalp, upper extremity and lower extremity reconstructive surgery procedures.

Da Vinci Robotic Surgical system to be used in procedures that harvest the latissimus dorsi muscle for reconstructive procedures

da Vinci® Robotic Surgical System

Latissimus dorsi muscle flap harvest procedure using da Vinci® Robotic Surgical System for use in reconstructive surgery.

LD muscle flap harvest procedure

Reconstructive surgery is considered to be standard of care.

Reconstructive surgery

Questionnaire about pain, as well as participant's shoulder, arm, and hand range of motion completed at baseline, and at follow up visits 3-6.

Questionnaires

Jesse C. Selber, MD

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.

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 visits, as listed in this consent form. All procedures will be performed on days in which standard of care procedures would already be performed.

If it is determined that participant is eligible, the following will be performed before the surgery:

* The study doctor or a member of the research team will review participant's medical information and ask participant questions about participant's medical history and demographic information.
* Participant will have a physical exam.
* Participant will be evaluated by a Physical Therapist to test participant's range of motion and strength.
* Participant will complete a questionnaire about pain, as well as participant's shoulder, arm, and hand range of motion. This information will be used to compare with the results after the surgery. This will take about 5 minutes to complete.
* Photographs and/or videos of the surgical site will be taken.
* If participant can become pregnant, participant will have a urine pregnancy test. To take part in this study, participant must not be pregnant.

Surgery Study Visit (2):

At this visit, participant's reconstructive surgery will be performed using a robot, called the Da Vinci® Robotic Surgical System. The reconstructive surgery is considered to be standard of care. Participant will be asked to sign a separate consent form that discusses the possible benefits and risks of the standard of care surgical procedure in more detail, including information about any anesthetic participant will be given for the surgery.

A standard muscle harvest procedure takes about 2 hours. A muscle harvest procedure with the robotic system is expected to take longer than the standard surgery. The total procedure time will vary for each patient depending on the type of muscle harvest procedure and other factors in the operating room. The total time to complete the muscle harvest and reconstruction will take about 4 hours. Photographs and/or videos of the surgical site will be taken.

Participant will remain in the hospital for 3-4 days after the surgery is complete for observation. After participant is discharged from the hospital, participant will need to return within 2 weeks for participant's first follow-up examination.

Follow-Up Study Visits (3-6):

After participant has been discharged from the hospital, participant will have 4 follow-up visits.

The first follow up visit will take place within two weeks after participant is discharged . The second follow-up visit will be between 2-4 weeks, the third follow up visit will be between 1-3 months and the fourth follow up will be between 3-6 months after participant is discharged.

The following tests and procedures will be performed at each follow-up visit:

* The study doctor will check the surgery site(s).
* Participant's overall health status will be checked.
* Participant will be evaluated by a Physical Therapist to test participant's range of motion and strength.
* Photographs and/or videos of the surgical site may be taken.
* Participant will complete the questionnaire about pain and participant's shoulder, arm, and hand range of motion. This information will be used to compare with the results from before the surgery.

Length of Study Participation:

Participation on the study will be over after the follow-up visits.

This is an investigational study. The use of the Da Vinci® Robotic Surgical System for surgery in the thorax (part of the upper body) is FDA approved and commercially available at this time. However, the system has not been FDA cleared specifically for use in latissimus dorsi muscle harvest procedures. The use of the DaVinci Robotic Surgical System for this type of reconstructive surgery has not been performed in live humans and is what researchers are investigating for this study.

Up to 15 patients will take part in this study. All will be enrolled at MD Anderson.

Robotic Harvest of the Latissimus Dorsi (LD) Muscles

Pilot Study of Robotic-Assisted Harvest of the Latissimus Dorsi Muscles

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

The participants listed were evaluated for donor site complication.

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

M.D. Anderson Cancer Center

Latissimus dorsi muscle harvest using the DaVinci robotic approach

Latissimus Dorsi Muscle Harvest

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Latissimus dorsi muscle function

Dr. Jesse C Selber / Professor, Plastic Surgery

All participants were assessed for the primary measure

Number of Participants Assessed for Donor Site Complications and Muscle Flap Viability

Number of Participants With LD Muscle Flap Viability Following Robotic-Assisted Harvest Procedure

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

Evaluation of Donor Site Complications Through 6 Months Post-procedure

LD Muscle Flap Failure Through 6 Months Post-procedure

Overall Study

Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Diseases and Abnormalities at or Before Birth

Breast Neoplasms

Congenital Abnormalities

Skin Abnormalities

Breast Diseases

Skin Diseases

adipose SVF cell transfer to the half of irradiated breast

Normal saline inject to the half of irradiated breast

Adipose SVF cell

Normal saline

Chanyeong Heo, Ph.D

The aim of this study is to evaluate the skin quality of using adipose-drived stromal vascular fraction (SVF) cell taken by automatic centrifuge for adipose-drived cell isolation system into irradiated breasts.

10 participants who taken conservative mastectomy will be enrolled

1. Process

   * adipose tissue is obtained from the subject's thigh or abdomen
   * adipose-drived stromal vascular fraction(SVF)cell isolation using automatic centrifuge system
   * adipose-drived stromal vascular fraction(SVF)cell graft into the irradiated breast.
2. Duration of study

   * entire duration: approximate 30weeks
   * Follow-up period: 12 weeks
   * Enrollment period: 12 weeks
3. Study design - Randomized, prospective, pilot study

Pilot Study of Skin Quality Improvement After Adipose-drived Stem Cell Transfer in Irradiated Breasts

The efficacy is assessed by breast skin thickness measured by radiologist using breast ultrasonography

Seoul National University Hospital

Symptoms and General Pathology

Heart and Blood Diseases

Ischemia

Head and Neck Neoplasms

Reperfusion Injury

Vascular Diseases

Postoperative Complications

Remote ischemic preconditioning (RIPC) consisted of 4 cycles of 5-min ischemia using pneumatic cuff pressure of 200 mmHg and 5-min reperfusion is applied to the upper arm of the patients in the RIPC group.

Sham-RIPC consisted of 4 cycles of 5-min ischemia using pneumatic cuff pressure of \< 10 mmHg and 5-min reperfusion is applied to the upper arm of the patients in the Sham-RIPC group.

RIPC consists of 4 cycles of 5-min ischemia using pneumatic cuff pressure of 200 mmHg and 5-min reperfusion.

remote ischemic preconditioning (RIPC)

Sham-RIPC consists of 4 cycles of 5-min ischemia using pneumatic cuff pressure of \< 10 mmHg and 5-min reperfusion.

Sham-RIPC

Youn Joung Cho, MD

Remote ischemic preconditioning (RIPC) has shown organ-protective effects in many clinical settings including patients with ischemic heart disease. However its protective role in head and neck cancer patients with preoperative radiotherapy undergoing free flap reconstructive surgery has not yet been evaluated. The purpose of the current study is to evaluate the effect of RIPC on tissue oxygen saturation and skin temperature of the flap.

Patients undergoing free flap reconstructive surgery for head and neck cancer with preoperative radiotherapy will be randomized to either remote ischemic preconditioning (RIPC) group or control group. On the day of surgery, after induction of anesthesia, RIPC, consisting of 4 cycles of 5-min ischemia (using pneumatic cuff pressure of 200 mmHg) followed by 5-min reperfusion at the upper arm, or sham-RIPC (pressure \< 10 mmHg) will be induced in the RIPC or control group, respectively. Before completion of surgery, RIPC or sham-RIPC will be repeated. Tissue oxygen saturation and skin temperature of the flap will be recorded until postoperative day 1.

RIPC During Free Flap With Preoperative Radiotherapy

Effects of Remote Ischemic Preconditioning During Free Flap Reconstruction in Head and Neck Cancer Patients With Preoperative Radiotherapy

skin temperature of the flap and the adjacent tissue

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Robotic Harvest of the Latissimus Dorsi (LD) Muscles	NCT02274493	Other Reconstru... Failure of Musc... Cancer Complications Surgical Proced...	da Vinci® Robot... LD muscle flap ... Reconstructive ... Questionnaires	18 Years -	M.D. Anderson Cancer Center
Pilot Study of Skin Quality Improvement After Adipose-drived Stem Cell Transfer in Irradiated Breasts	NCT01801878	Breast Neoplasm... Skin Abnormalit...	Adipose SVF cel... Normal saline	40 Years - 60 Years	Seoul National University Hospital
RIPC During Free Flap With Preoperative Radiotherapy	NCT03535623	Ischemic Reperf... Other Reconstru... Radiotherapy	remote ischemic... Sham-RIPC	20 Years -	Seoul National University Hospital

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