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

NCT03716050 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: IRB00038262
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Perfusion; Complications

Keywords

breast reconstruction; Breast Cancer; Implant Complication

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• 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

Study Arms (8)

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.

Other: No treatment

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.

Drug: Nitroglycerin

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.

Device: Negative Pressure Wound Therapy/ Wound VAC

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.

Drug: Nitroglycerin; Device: Negative Pressure Wound Therapy/ Wound VAC

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.

Other: Fluorescent Angiography with indocyanine-green (not to exceed 5mg/kg)

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.

Drug: Nitroglycerin; Other: Fluorescent Angiography with indocyanine-green (not to exceed 5mg/kg)

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.

Device: Negative Pressure Wound Therapy/ Wound VAC; Other: Fluorescent Angiography with indocyanine-green (not to exceed 5mg/kg)

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.

Drug: Nitroglycerin; Device: Negative Pressure Wound Therapy/ Wound VAC; Other: Fluorescent Angiography with indocyanine-green (not to exceed 5mg/kg)

Interventions

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.

Also known as: Nitro-Bid 2%

Group 2; Group 4; Group 6; Group 8

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.

Also known as: iVAC

Group 3; Group 4; Group 7; Group 8

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.

Group 5; Group 6; Group 7; Group 8

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.

Group 1

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Patient's must be females, diagnosed with breast cancer and desiring breast reconstruction
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Nitroglycerin; Negative-Pressure Wound Therapy; Indocyanine Green

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals; Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Ivo Pestana
• Organization: Wake Forest Baptist Health

ipestana@wakehealth.edu

336-716-4171

Study Officials

• Ivo A Pestana, MD

  WFUHS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: October 23, 2018
• Study Start: January 30, 2018
• Primary Completion: March 12, 2019
• Study Completion: March 12, 2019
• Last Updated: May 21, 2020
• Results First Posted: December 18, 2019

Record last verified: 2019-09

Locations

US (1)