Clinical trial · Interventional
The Effect of Nitroglycerin Ointment, Fluorescent Angiography, and Incisional Negative Pressure Wound Therapy on Mastectomy Skin Flap Perfusion-Related Problems
NCT03716050CI-TRIAL-00045201terminatedPhase 2 / Phase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI decision due to slow accrual
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Perfusion; Complications | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorescent Angiography with indocyanine-green (not to exceed 5mg/kg) | Other | — | UNRESOLVED |
| Negative Pressure Wound Therapy/ Wound VAC | Device | — | UNRESOLVED |
| Nitroglycerin | Drug | — | UNRESOLVED |
| No treatment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (8)
- type
- OTHER
- label
- Group 1
- description
- 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.
- interventionNames
- Other: No treatment
- type
- ACTIVE_COMPARATOR
- label
- Group 2
- description
- 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.
- interventionNames
- Drug: Nitroglycerin
- type
- ACTIVE_COMPARATOR
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.