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NCT03716050

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

Terminated Phase 2, PHASE3 Results posted Last updated 21 May 2020
What this trial tests

Phase 2, PHASE3 trial testing Nitroglycerin in Perfusion; Complications in 17 participants. Terminated before completion.

Timeline
30 January 2018
Primary endpoint
12 March 2019
12 March 2019

Quick facts

Lead sponsorWake Forest University Health Sciences
PhasePhase 2, PHASE3
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designfactorial
Maskingnone
Primary purposeprevention
Enrollment17
Start date30 January 2018
Primary completion12 March 2019
Estimated completion12 March 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Wake Forest University Health Sciences

Who can join

Adults 18 to 99, female only, with Perfusion; Complications. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Soft Tissue Ischemia/Loss Primary · Up to 30 days

Number of partial and full thickness soft tissue defects identified postoperatively in clinic follow up

GroupValue95% CI
Group 10
Group 20
Group 30
Group 40
Group 50
Group 70
Group 80
Number of Participants With Surgical Site Infection Primary · Up to 30 days

Number of Participants with soft tissue cellulitis or abscess identified postoperatively either clinically or with wound culture

GroupValue95% CI
Group 10
Group 20
Group 30
Group 40
Group 50
Group 70
Group 80
Number of Participants With Delayed Wound Healing Primary · Up to 30 days

manifesting as suture dehiscence and opening of an incisional wound

GroupValue95% CI
Group 10
Group 20
Group 30
Group 40
Group 50
Group 70
Group 80
Number of Participants With Operative Intervention Secondary to Perfusion Related Problems Secondary · Up to 30 days
GroupValue95% CI
Group 10
Group 20
Group 30
Group 40
Group 50
Group 70
Group 80
Number of Participants Requiring Outpatient Prescription for Antibiotics or Requiring Hospital Admission for IV Antibiotics Secondary · Up to 30 days
GroupValue95% CI
Group 10
Group 20
Group 30
Group 40
Group 50
Group 70
Group 80
Number of Participants Requiring Wound Care Management Modalities for Treatment of Delayed Wound Healing Complications Secondary · up to 30 days
GroupValue95% CI
Group 10
Group 20
Group 30
Group 40
Group 50
Group 70
Group 80

Adverse events — posted to ClinicalTrials.gov

Time frame: From the time subjects sign consent through Week 4 (30 days). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group 1
Serious: 0/2 (0%)
Deaths: 0/2
Group 2
Serious: 0/4 (0%)
Deaths: 0/4
Group 3
Serious: 0/1 (0%)
Deaths: 0/1
Group 4
Serious: 0/3 (0%)
Deaths: 0/3
Group 5
Serious: 0/1 (0%)
Deaths: 0/1
Group 6
Serious: 0
Deaths: 0
Group 7
Serious: 0/4 (0%)
Deaths: 0/4
Group 8
Serious: 0/2 (0%)
Deaths: 0/2
Other adverse events (1 terms — click to expand)

ReactionSystemGroup 1Group 2Group 3Group 4Group 5Group 6Group 7Group 8
PainSurgical and medical procedures————————

Data from ClinicalTrials.gov NCT03716050 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Clinical research nurse predictions of trial failure, recruitment and retention: a case for their early inclusion in trial design.
    Shiely F, Murphy D, Millar SR. · · 2023 · cited 5× · PMID 37464255 · DOI 10.1186/s13063-023-07504-9

Verify or expand the search:

Other trials of Nitroglycerin

Trials testing the same drug.

Other recruiting trials for Perfusion; Complications

Currently open trials in the same condition.

Other Wake Forest University Health Sciences trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03716050.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing