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PI decision due to slow accrual
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Other | 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. |
|
| Group 2 | Active Comparator | 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 | Active Comparator | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitroglycerin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Soft Tissue Ischemia/Loss | Number of partial and full thickness soft tissue defects identified postoperatively in clinic follow up | Up to 30 days |
| Number of Participants With Surgical Site Infection | Number of Participants with soft tissue cellulitis or abscess identified postoperatively either clinically or with wound culture | Up to 30 days |
| Number of Participants With Delayed Wound Healing | manifesting as suture dehiscence and opening of an incisional wound | Up to 30 days |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Patient's must be females, diagnosed with breast cancer and desiring breast reconstruction
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| Name | Affiliation | Role |
|---|---|---|
| Ivo A Pestana, MD | WFUHS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 7, 2019 |
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| Group 5 |
| Active Comparator |
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 | Active Comparator | 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 | Active Comparator | 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 | Active Comparator | 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. |
|
|
| Negative Pressure Wound Therapy/ Wound VAC | Device | 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) | Other | 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. |
|
| No treatment | Other | 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. |
|
| Number of Participants Requiring Wound Care Management Modalities for Treatment of Delayed Wound Healing Complications | up to 30 days |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| FG006 | 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. |
| FG007 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
There were no participants randomized to group 6
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | 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. |
| BG007 | 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. |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Soft Tissue Ischemia/Loss | Number of partial and full thickness soft tissue defects identified postoperatively in clinic follow up | There were no participants randomized to group 6 | Posted | Number | number of defects | Up to 30 days |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||
| 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 | Posted | Count of Participants | Participants | Up to 30 days |
| |||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Delayed Wound Healing | manifesting as suture dehiscence and opening of an incisional wound | Posted | Count of Participants | Participants | Up to 30 days |
| |||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Operative Intervention Secondary to Perfusion Related Problems | Posted | Count of Participants | Participants | Up to 30 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Requiring Outpatient Prescription for Antibiotics or Requiring Hospital Admission for IV Antibiotics | Posted | Count of Participants | Participants | Up to 30 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Requiring Wound Care Management Modalities for Treatment of Delayed Wound Healing Complications | Posted | Count of Participants | Participants | up to 30 days |
|
From the time subjects sign consent through Week 4 (30 days)
There were no subjects randomized to group 6
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG001 | 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. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG002 | 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. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG003 | 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. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG004 | 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. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG005 | 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 | 0 | 0 | 0 | 0 | 0 |
| EG006 | 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. | 0 | 4 | 0 | 4 | 1 | 4 |
| EG007 | 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. | 0 | 2 | 0 | 2 | 0 | 2 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Surgical and medical procedures | Systematic Assessment | Pain with removal of wound VAC |
|
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ivo Pestana | Wake Forest Baptist Health | 336-716-4171 | ipestana@wakehealth.edu |
| Dec 2, 2019 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 17, 2019 | May 8, 2020 | ICF_001.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005996 | Nitroglycerin |
| D054843 | Negative-Pressure Wound Therapy |
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
|
|
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
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| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
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| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
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| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
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