GynecomastiaPhase 3NCT04321967
Nitropaste in Breast Reduction
A Phase 3 study testing Nitroglycerin Paste and Dermabond in people with Gynecomastia and Delayed Wound Healing, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The purpose of this study is evaluate the effect of Nitroglycerin paste on wound healing and scarring. Previous research has shown that Nitroglycerin paste can improve the blood flow to a wound, which may be associated with better wound healing, and ultimately, better scarring. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Gynecomastia, Delayed Wound Healing
- What is being tested?
- Nitroglycerin Paste and Dermabond
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2019to 1 Nov 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients who are female and transmen
- Undergoing bilateral breast reduction via Mount Sinai Plastic Surgery Clinic
- Reduction must be performed via Wise incisional pattern
Who cannot join
- Patients who are male or transwomen
- Patients who are under 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topical Nitroglycerin as a Mechanism for Cutaneous Vaso-modulation and Improved Wound Healing After Breast Reduction
The purpose of this study is evaluate the effect of Nitroglycerin paste on wound healing and scarring. Previous research has shown that Nitroglycerin paste can improve the blood flow to a wound, which may be associated with better wound healing, and ultimately, better scarring.
Read the detailed description
This will be a single-center, patient-blinded, (breast) randomized trial utilizing nitroglycerin paste on their breast reduction scar. The study team aims to randomize 100 patients, or 200 breasts. Each patient will receive treatment, but the breast that received treatment will be random. This will allow for a control breast to compare to. Patients will be followed for 12 months postoperatively to observe wound healing.
- Conditions
- Gynecomastia, Delayed Wound Healing
- Being tested
- Nitroglycerin Paste, Dermabond
- Keywords
- Nitroglycerin paste, Scarring, Necrosis, Wound healing, Breast, Breast reduction
- Medical subject headings
- Gynecomastia, Cicatrix, Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitroglycerin PasteDrug
1g of 2% Nitroglycerin paste topical application
DermabondDrug
Topical skin adhesive
| Study group | Role | What they receive |
|---|---|---|
| Nitroglycerine paste | Experimental | The randomized breast will receive Nitroglycerine paste and Dermabond. Receives: Drug: Nitroglycerin Paste; Drug: Dermabond |
| Dermabond | Placebo comparator | The control breast will receive Dermabond only Receives: Drug: Dermabond |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vancouver Scar Scoring (VSS)
Change in Vancouver Scar Scoring at 12 as compared to first post visit. VSS is a standardized scar appearance protocol - full score from 0-13, with higher score indicating poorer health outcomes.
Measured: First post-op visit (0 weeks post op) and last visit at 12 months
Secondary outcomes (2)
Number of occurrences of wound breakdown
Change in number of occurrence of necrosis and/or wound breakdown at 12 months as compared to the first post-op visit
Measured: 12 months
Number of side-effects of Nitroglycerin use
Side effects of nitroglycerine use measured as a composite of side effects which includes pre-syncope, syncope, chest pains and headache.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start20 Aug 2019
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Why it stopped: Unable to recruit patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GynecomastiaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients who agree to participate will be randomized during their bilateral breast reduction procedure. Each patient will be randomized to "LEFT BREAST" or "RIGHT BREAST." The randomization result will determine which breast receives the nitroglycerin paste. Their breast reduction will be done using the Wise pattern, and all incisions will be sealed with Dermabond. At the conclusion of the procedure, 1g of topical nitroglycerin (2%) will be placed on the breast which the randomizer indicated. Patients will be monitored for AEs during the remainder of their hospital stay.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter J. Taub, Icahn School of Medicine at Mount Sinai
- Investigators
- Peter Taub, M.D., Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321967
- Sponsor's protocol ID
- GCO 19-0387
- Status last verified
- Jan 2021
- First submitted
- 24 Mar 2020
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD and related data dictionaries available. The PI does not plan to share data at the conclusion of the study beyond what is published
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Nitroglycerin as a Mechanism for Cutaneous Vaso-modulation and Improved Wound Healing After Breast Reduction
- ClinicalTrials.gov ID
- NCT04321967
- Acronym / sponsor ID
- GCO 19-0387
- Conditions
- Gynecomastia, Delayed Wound Healing
- Keywords
- Nitroglycerin paste, Scarring, Necrosis, Wound healing, Breast, Breast reduction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is evaluate the effect of Nitroglycerin paste on wound healing and scarring. Previous research has shown that Nitroglycerin paste can improve the blood flow to a wound, which may be associated with better wound healing, and ultimately, better scarring.
Detailed description
This will be a single-center, patient-blinded, (breast) randomized trial utilizing nitroglycerin paste on their breast reduction scar. The study team aims to randomize 100 patients, or 200 breasts. Each patient will receive treatment, but the breast that received treatment will be random. This will allow for a control breast to compare to. Patients will be followed for 12 months postoperatively to observe wound healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Patients who agree to participate will be randomized during their bilateral breast reduction procedure. Each patient will be randomized to "LEFT BREAST" or "RIGHT BREAST." The randomization result will determine which breast receives the nitroglycerin paste. Their breast reduction will be done using the Wise pattern, and all incisions will be sealed with Dermabond. At the conclusion of the procedure, 1g of topical nitroglycerin (2%) will be placed on the breast which the randomizer indicated. Patients will be monitored for AEs during the remainder of their hospital stay.
| Arm | Type | Receives |
|---|---|---|
| Nitroglycerine paste | Experimental | Drug: Nitroglycerin Paste, Drug: DermabondThe randomized breast will receive Nitroglycerine paste and Dermabond. |
| Dermabond | Placebo comparator | Drug: DermabondThe control breast will receive Dermabond only |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients who are female and transmen
- Undergoing bilateral breast reduction via Mount Sinai Plastic Surgery Clinic
- Reduction must be performed via Wise incisional pattern
Key exclusion criteria (2 listed)
- Patients who are male or transwomen
- Patients who are under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitroglycerin Paste1g of 2% Nitroglycerin paste topical application | Drug | Nitroglycerine paste |
| DermabondTopical skin adhesive | Drug | Dermabond, Nitroglycerine paste |
Primary outcome
Change in Vancouver Scar Scoring (VSS)
Time frame: First post-op visit (0 weeks post op) and last visit at 12 months
Change in Vancouver Scar Scoring at 12 as compared to first post visit. VSS is a standardized scar appearance protocol - full score from 0-13, with higher score indicating poorer health outcomes.
2 secondary outcomes
Number of occurrences of wound breakdown
Time frame: 12 months
Number of side-effects of Nitroglycerin use
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Individual participant dataSharing planned: No. There is not a plan to make IPD and related data dictionaries available. The PI does not plan to share data at the conclusion of the study beyond what is published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Taub, M.D. principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nitroglycerin Paste and Dermabond in people with Gynecomastia and Delayed Wound Healing, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Vancouver Scar Scoring (VSS) (time frame: First post-op visit (0 weeks post op) and last visit at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.