Perfusion; Complications
Conditions
Keywords
breast reconstruction, Breast Cancer, Implant Complication
Brief summary
This is a randomized study using a variety of techniques to compare and examine blood flow to the remaining skin after mastectomy. All treatments being used are considered standard of care and are not experimental. The objective is to compare the techniques and the incidence of perfusion related problems in patient's undergoing mastectomy with immediate breast reconstruction.
Detailed description
This study's aim is to evaluate and compare a variety of interventions and their effect on the incidence of perfusion related problems in patients with breast cancer undergoing mastectomy and implant-based immediate breast reconstruction (IBR). The ability to identify, prevent and treat these perfusion related problems can help maximize aesthetic results after breast surgery, improve patient satisfaction with both mastectomy and breast reconstruction, and reduce healthcare cost associated with mastectomy and reconstruction complications.The study team will perform a randomized pilot study comprised of eight groups. All of these groups employ accepted techniques, medications and dressings and therefore are not experimental. Group 1: Breast skin after mastectomy will be clinically examined by the surgeon to determine if there is adequate blood flow to the skin to allow safe coverage of the breast implant. No dye study, ointment, or vacuum dressing will be applied to the breast after implant placement. Group 2 - Breast skin after mastectomy will be clinically examined by the surgeon, and nitroglycerin (NTG) cream will be applied to the breast skin after implant placement. This cream does not have systemic effects but may improve blood flow to the remnant breast skin after mastectomy. Group 3 - Breast skin after mastectomy will be clinically examined by the surgeon, and an incisional vacuum-assisted dressing (iVAC) will be placed over the breast incisions after implant placement, which may improve blood flow to the skin and help wound healing. Group 4 - Breast skin after mastectomy will be clinically examined by the surgeon, and both NTG cream will be applied to the breast skin and an iVAC will be placed over the incisions after implant placement. Group 5 - Blood flow to breast skin after mastectomy will be examined using a fluorescent dye study called fluorescent angiography (FA) to determine if there is adequate blood flow to the skin to allow safe coverage of the breast implant. No further intervention will be used after implant placement. Group 6 - Blood flow to breast skin breast skin will be examined using FA, and NTG cream will be applied to the skin after the implant is placed. Group 7 - Blood flow to breast skin breast skin will be examined using FA, and an iVAC will be placed over breast skin incisions after the implant is placed. Group 8 - Blood flow to breast skin breast skin will be examined using FA, and both NTG cream and iVAC will be used as interventions after the implant is placed. The dosage of indocyanine-green (IC-green) to be used for assessment of mastectomy flaps will be in 10 mg boluses, not to exceed 5 mg/kg. Nitro-Bid® (nitroglycerin ointment, 2%) at a dose of 45 mg (equal to 7.5 cm on the measuring strip provided with packaging) will be used. The paste will be applied to remnant breast skin after skin closure and surgical dressings placed over top. Incisional negative pressure wound therapy will consist of a standard sponge dressing with adhesive drape, either Ioban® 2 (3M ™) or KCI-V.A.C.® Drape (KCI®), to continuous suction at 125 mm Hg while the patient is in hospital and not to exceed 4 days. A physician will see the subjects on a regular weekly basis for up to 30 days once the procedure has been completed. These clinical visits are standard of care and the subject's health and well-being will be monitored rigorously during these visits. If during any of these visits, the physician deems a therapy necessary to prevent impairment/damage and improve well-being, the subject will be treated appropriately.
Interventions
DRUGNitroglycerin
Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 2,4,6, and 8 will include Nitroglycerin cream.
DEVICENegative Pressure Wound Therapy/ Wound VAC
Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 3,4,7,and 8 will receive iVAC therapy.
OTHERFluorescent Angiography with indocyanine-green (not to exceed 5mg/kg)
Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 5,6,7,and 8 will receive angiography.
OTHERNo treatment
Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 1 will include no treatment.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients must be female. * Patients must be between the ages of 18 and 99 years. * Patients must undergo mastectomy with our attending breast oncology surgeons followed by possible implant-based immediate breast reconstruction (IBR) performed by our attending plastic surgeons at WFBMC. * Patients must have the ability to understand and the willingness to sign an IRB-approved informed consent document.
Exclusion criteria
* Patients who are under the age of 18 or over the age of 99. * Patients who are undergoing mastectomy without immediate breast reconstruction including immediate breast reconstruction with autologous tissue (or combination of autologous tissue with tissue expanders or implants), or patients with a history of mastectomy presenting for delayed breast reconstruction. * Patients with pre-existing conditions in which use of indocyanine-green is contraindicated or must be used with caution, including those with a history of allergy to iodides or iodinated dye, those with chronic kidney disease, those with hepatic failure or cirrhosis of the liver, and females who are nursing, pregnant, or may become pregnant. * Pregnant women are excluded from this study because pregnancy precludes immediate breast reconstruction in our patient population. * Patients with pre-existing conditions in which use of nitroglycerin paste is contraindicated, including those with a history of cardiac insufficiency, hypotension, sensitivity to nitrites, severe liver impairment, glaucoma, hyperthyroidism, recent head trauma, severe anemia, or taking certain medication (i.e. alteplase, aspirin, beta-blocker, calcium channel blocker, diuretics or thiazides). * Patients with pre-existing conditions in whom use of incisional negative pressure wound therapy is contraindicated including those with evidence of surgical site infection ( i.e. erythema, purulent drainage), clinical signs of hematoma (i.e. wound swelling, fluctuance, blood drainage), history of persistent cancer, exposed blood vessel on site of proposed therapeutic use, or sensitivity to acrylics and adhesives.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Soft Tissue Ischemia/Loss | Up to 30 days | Number of partial and full thickness soft tissue defects identified postoperatively in clinic follow up |
| Number of Participants With Surgical Site Infection | Up to 30 days | Number of Participants with soft tissue cellulitis or abscess identified postoperatively either clinically or with wound culture |
| Number of Participants With Delayed Wound Healing | Up to 30 days | manifesting as suture dehiscence and opening of an incisional wound |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Operative Intervention Secondary to Perfusion Related Problems | Up to 30 days |
| Number of Participants Requiring Outpatient Prescription for Antibiotics or Requiring Hospital Admission for IV Antibiotics | Up to 30 days |
| Number of Participants Requiring Wound Care Management Modalities for Treatment of Delayed Wound Healing Complications | up to 30 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Breast skin after mastectomy will be clinically examined by the surgeon to determine if there is adequate blood flow to the skin to allow safe coverage of the breast implant. No treatment, including dye study, ointment, or vacuum dressing will be applied to the breast after implant placement.
No treatment: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 1 will include no treatment. | 2 |
| Group 2 Breast skin after mastectomy will be clinically examined by the surgeon, and nitroglycerin (NTG) cream will be applied to the breast skin after implant placement. This cream does not have systemic effects but may improve blood flow to the remnant breast skin after mastectomy.
Nitroglycerin: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 2,4,6, and 8 will include Nitroglycerin cream. | 4 |
| Group 3 Breast skin after mastectomy will be clinically examined by the surgeon, and an incisional vacuum-assisted dressing (iVAC) will be placed over the breast incisions after implant placement, which may improve blood flow to the skin and help wound healing.
Negative Pressure Wound Therapy/ Wound VAC: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 3,4,7,and 8 will receive iVAC therapy. | 1 |
| Group 4 Breast skin after mastectomy will be clinically examined by the surgeon, and both NTG cream will be applied to the breast skin and an iVAC will be placed over the incisions after implant placement.
Nitroglycerin: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 2,4,6, and 8 will include Nitroglycerin cream.
Negative Pressure Wound Therapy/ Wound VAC: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 3,4,7,and 8 will receive iVAC therapy. | 3 |
| Group 5 Blood flow to breast skin after mastectomy will be examined using a fluorescent dye study called fluorescent angiography (FA) to determine if there is adequate blood flow to the skin to allow safe coverage of the breast implant. No further intervention will be used after implant placement.
Fluorescent Angiography with indocyanine-green (not to exceed 5mg/kg): Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 5,6,7,and 8 will receive angiography. | 1 |
| Group 6 Blood flow to breast skin breast skin will be examined using FA, and NTG cream will be applied to the skin after the implant is placed.
Nitroglycerin: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 2,4,6, and 8 will include Nitroglycerin cream.
Fluorescent Angiography with indocyanine-green (not to exceed 5mg/kg): Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 5,6,7,and 8 will receive angiography. | 0 |
| Group 7 Blood flow to breast skin breast skin will be examined using FA, and an iVAC will be placed over breast skin incisions after the implant is placed.
Negative Pressure Wound Therapy/ Wound VAC: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 3,4,7,and 8 will receive iVAC therapy.
Fluorescent Angiography with indocyanine-green (not to exceed 5mg/kg): Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 5,6,7,and 8 will receive angiography. | 4 |
| Group 8 Blood flow to breast skin breast skin will be examined using FA, and both NTG cream and iVAC will be used as interventions after the implant is placed.
Nitroglycerin: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 2,4,6, and 8 will include Nitroglycerin cream.
Negative Pressure Wound Therapy/ Wound VAC: Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 3,4,7,and 8 will receive iVAC therapy.
Fluorescent Angiography with indocyanine-green (not to exceed 5mg/kg): Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 5,6,7,and 8 will receive angiography. | 2 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | Group 2 | Group 1 | Group 3 | Group 4 | Group 5 | Group 6 | Group 7 | Group 8 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 2 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 4 Participants | 2 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 2 Participants | 1 Participants | 3 Participants | 1 Participants | 0 Participants | 4 Participants | 2 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 1 Participants | 3 Participants | 1 Participants | 0 Participants | 4 Participants | 2 Participants | 17 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 4 | 0 / 1 | 0 / 3 | 0 / 1 | 0 / 0 | 0 / 4 | 0 / 2 |
| other Total, other adverse events | 0 / 2 | 0 / 4 | 0 / 1 | 0 / 3 | 0 / 1 | 0 / 0 | 1 / 4 | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 4 | 0 / 1 | 0 / 3 | 0 / 1 | 0 / 0 | 0 / 4 | 0 / 2 |
Outcome results
Primary
Number of Participants With Delayed Wound Healing
manifesting as suture dehiscence and opening of an incisional wound
Time frame: Up to 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 | Number of Participants With Delayed Wound Healing | 0 Participants |
| Group 2 | Number of Participants With Delayed Wound Healing | 0 Participants |
| Group 3 | Number of Participants With Delayed Wound Healing | 0 Participants |
| Group 4 | Number of Participants With Delayed Wound Healing | 0 Participants |
| Group 5 | Number of Participants With Delayed Wound Healing | 0 Participants |
| Group 7 | Number of Participants With Delayed Wound Healing | 0 Participants |
| Group 8 | Number of Participants With Delayed Wound Healing | 0 Participants |
Primary
Number of Participants With Surgical Site Infection
Number of Participants with soft tissue cellulitis or abscess identified postoperatively either clinically or with wound culture
Time frame: Up to 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 | Number of Participants With Surgical Site Infection | 0 Participants |
| Group 2 | Number of Participants With Surgical Site Infection | 0 Participants |
| Group 3 | Number of Participants With Surgical Site Infection | 0 Participants |
| Group 4 | Number of Participants With Surgical Site Infection | 0 Participants |
| Group 5 | Number of Participants With Surgical Site Infection | 0 Participants |
| Group 7 | Number of Participants With Surgical Site Infection | 0 Participants |
| Group 8 | Number of Participants With Surgical Site Infection | 0 Participants |
Primary
Number of Soft Tissue Ischemia/Loss
Number of partial and full thickness soft tissue defects identified postoperatively in clinic follow up
Time frame: Up to 30 days
Population: There were no participants randomized to group 6
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Number of Soft Tissue Ischemia/Loss | 0 number of defects |
| Group 2 | Number of Soft Tissue Ischemia/Loss | 0 number of defects |
| Group 3 | Number of Soft Tissue Ischemia/Loss | 0 number of defects |
| Group 4 | Number of Soft Tissue Ischemia/Loss | 0 number of defects |
| Group 5 | Number of Soft Tissue Ischemia/Loss | 0 number of defects |
| Group 7 | Number of Soft Tissue Ischemia/Loss | 0 number of defects |
| Group 8 | Number of Soft Tissue Ischemia/Loss | 0 number of defects |
Secondary
Number of Participants Requiring Outpatient Prescription for Antibiotics or Requiring Hospital Admission for IV Antibiotics
Time frame: Up to 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 | Number of Participants Requiring Outpatient Prescription for Antibiotics or Requiring Hospital Admission for IV Antibiotics | 0 Participants |
| Group 2 | Number of Participants Requiring Outpatient Prescription for Antibiotics or Requiring Hospital Admission for IV Antibiotics | 0 Participants |
| Group 3 | Number of Participants Requiring Outpatient Prescription for Antibiotics or Requiring Hospital Admission for IV Antibiotics | 0 Participants |
| Group 4 | Number of Participants Requiring Outpatient Prescription for Antibiotics or Requiring Hospital Admission for IV Antibiotics | 0 Participants |
| Group 5 | Number of Participants Requiring Outpatient Prescription for Antibiotics or Requiring Hospital Admission for IV Antibiotics | 0 Participants |
| Group 7 | Number of Participants Requiring Outpatient Prescription for Antibiotics or Requiring Hospital Admission for IV Antibiotics | 0 Participants |
| Group 8 | Number of Participants Requiring Outpatient Prescription for Antibiotics or Requiring Hospital Admission for IV Antibiotics | 0 Participants |
Secondary
Number of Participants Requiring Wound Care Management Modalities for Treatment of Delayed Wound Healing Complications
Time frame: up to 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 | Number of Participants Requiring Wound Care Management Modalities for Treatment of Delayed Wound Healing Complications | 0 Participants |
| Group 2 | Number of Participants Requiring Wound Care Management Modalities for Treatment of Delayed Wound Healing Complications | 0 Participants |
| Group 3 | Number of Participants Requiring Wound Care Management Modalities for Treatment of Delayed Wound Healing Complications | 0 Participants |
| Group 4 | Number of Participants Requiring Wound Care Management Modalities for Treatment of Delayed Wound Healing Complications | 0 Participants |
| Group 5 | Number of Participants Requiring Wound Care Management Modalities for Treatment of Delayed Wound Healing Complications | 0 Participants |
| Group 7 | Number of Participants Requiring Wound Care Management Modalities for Treatment of Delayed Wound Healing Complications | 0 Participants |
| Group 8 | Number of Participants Requiring Wound Care Management Modalities for Treatment of Delayed Wound Healing Complications | 0 Participants |
Secondary
Number of Participants With Operative Intervention Secondary to Perfusion Related Problems
Time frame: Up to 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 | Number of Participants With Operative Intervention Secondary to Perfusion Related Problems | 0 Participants |
| Group 2 | Number of Participants With Operative Intervention Secondary to Perfusion Related Problems | 0 Participants |
| Group 3 | Number of Participants With Operative Intervention Secondary to Perfusion Related Problems | 0 Participants |
| Group 4 | Number of Participants With Operative Intervention Secondary to Perfusion Related Problems | 0 Participants |
| Group 5 | Number of Participants With Operative Intervention Secondary to Perfusion Related Problems | 0 Participants |
| Group 7 | Number of Participants With Operative Intervention Secondary to Perfusion Related Problems | 0 Participants |
| Group 8 | Number of Participants With Operative Intervention Secondary to Perfusion Related Problems | 0 Participants |