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The Effect of Nitroglycerin Ointment, Fluorescent Angiography, and Incisional Negative Pressure Wound Therapy on Mastectomy Skin Flap Perfusion-Related Problems

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ClinicalTrials.gov Identifier: NCT03716050
Recruitment Status : Terminated (PI decision due to slow accrual)
First Posted : October 23, 2018
Results First Posted : December 18, 2019
Last Update Posted : December 18, 2019
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Perfusion; Complications Drug: Nitroglycerin Device: Negative Pressure Wound Therapy/ Wound VAC Other: Fluorescent Angiography with indocyanine-green (not to exceed 5mg/kg) Other: No treatment Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Nitroglycerin Ointment, Fluorescent Angiography, and Incisional Negative Pressure Wound Therapy on Mastectomy Skin Flap Perfusion-Related Problems
Actual Study Start Date : January 30, 2018
Actual Primary Completion Date : March 12, 2019
Actual Study Completion Date : March 12, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: 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.

Active Comparator: 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.
Drug: 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.
Other Name: Nitro-Bid 2%

Active Comparator: 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.
Device: 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.
Other Name: iVAC

Active Comparator: 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.
Drug: 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.
Other Name: Nitro-Bid 2%

Device: 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.
Other Name: iVAC

Active Comparator: 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.
Other: 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.

Active Comparator: 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.
Drug: 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.
Other Name: Nitro-Bid 2%

Other: 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.

Active Comparator: 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.
Device: 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.
Other Name: iVAC

Other: 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.

Active Comparator: 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.
Drug: 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.
Other Name: Nitro-Bid 2%

Device: 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.
Other Name: iVAC

Other: 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.




Primary Outcome Measures :
  1. Number of Soft Tissue Ischemia/Loss [ Time Frame: Up to 30 days ]
    Number of partial and full thickness soft tissue defects identified postoperatively in clinic follow up

  2. Number of Participants With Surgical Site Infection [ Time Frame: Up to 30 days ]
    Number of Participants with soft tissue cellulitis or abscess identified postoperatively either clinically or with wound culture

  3. Number of Participants With Delayed Wound Healing [ Time Frame: Up to 30 days ]
    manifesting as suture dehiscence and opening of an incisional wound


Secondary Outcome Measures :
  1. Number of Participants With Operative Intervention Secondary to Perfusion Related Problems [ Time Frame: Up to 30 days ]
  2. Number of Participants Requiring Outpatient Prescription for Antibiotics or Requiring Hospital Admission for IV Antibiotics [ Time Frame: Up to 30 days ]
  3. Number of Participants Requiring Wound Care Management Modalities for Treatment of Delayed Wound Healing Complications [ Time Frame: up to 30 days ]


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Patient's must be females, diagnosed with breast cancer and desiring breast reconstruction
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716050


Locations
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United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Ivo A Pestana, MD WFUHS
  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03716050    
Other Study ID Numbers: IRB00038262
First Posted: October 23, 2018    Key Record Dates
Results First Posted: December 18, 2019
Last Update Posted: December 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Wake Forest University Health Sciences:
breast reconstruction
Breast Cancer
Implant Complication
Additional relevant MeSH terms:
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Nitroglycerin
Vasodilator Agents