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Nitropaste is a topical agent that contains 2% nitroglycerin. It is an effective vascular smooth dilator, with more powerful effect on venous vasculature than arterial vasculature. While its main indication is for angina pectoris, there have been many studies showing improved survival of axial and random pattern flaps. Furthermore, recent clinical studies highlight significantly decreased mastectomy flap wound complication and need for sharp debridement. Nitropaste has low rates of side effects and is very well tolerated in general. To this date, there's no study that investigates its utility on patients who are undergoing chest masculinizing surgery. The purpose of this study is to investigate the potential utility of nitropaste in reducing rates of wound complications in patients undergoing chest masculinizing surgery.
Nitropaste is a topical agent that contains 2% nitroglycerin. It is an effective vascular smooth dilator, with more powerful effect on venous vasculature than arterial vasculature. While its main indication is for angina pectoris, there have been many studies showing improved survival of axial and random pattern flaps. Furthermore, recent clinical studies highlight significantly decreased mastectomy flap wound complication and need for sharp debridement. Nitropaste has low rates of side effects and is very well tolerated in general. To this date, there's no study that investigates its utility on patients who are undergoing chest masculinizing surgery. The purpose of this study is to investigate the potential utility of nitropaste in reducing rates of wound complications in patients undergoing chest masculinizing surgery utilizing double incision with free nipple grafting technique. The investigators will conduct a prospective, randomized, single-blinded study and compare nitropaste vs. no nitropaste on mastectomy flaps. Nitropaste will be applied intraoperatively and the patients will not have to re-apply it. Follow up will occur on post-op day 5, 2 weeks, and 6 weeks during their routine postop visits. A study coordinator will document the condition of free nipple grafts and any other wounds at surgical site if present, which will be the primary outcome. Any complications including hematoma, seroma, infection, hypertrophic scarring, need for sharp debridement, 30 day ED visit or admission rates will be documented as secondary outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No nitropaste group | No Intervention | Participants get standard of care chest masculinizing surgery utilizing double incision and free nipple grafting surgery. They will get standard dressing applied, which includes Xeroform bolster over the nipple grafts + Tegederm over the bolster and surgical site and instructed not to remove the dressing until they come to clinic on POD5 for bolster take down. | |
| Nitropaste group | Experimental | Participants get standard of care chest masculinizing surgery utilizing double incision and free nipple grafting surgery. They will then get 2 packets of nitropaste applied (1 on each chest) around the free nipple graft and surgical sites. They will then get standard dressing applied, which includes Xeroform bolster over the nipple grafts + Tegederm over the bolster and surgical site and instructed not to remove the dressing until they come to clinic on POD5 for bolster take down. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitro-Bid 2 % Topical Ointment | Drug | Intervention group will get 30mg of Nitro-Bid topical ointment applied over the chest (15mg/ 1 packet on each side) one time intra-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Free Nipple Graft Take | Rate of partial nipple graft loss (0-50%, 50% or more) or Complete nipple graft loss | Will be assessed at 5 days, 2 weeks, 6 weeks post-op |
| Wounds | Rate of superficial wound, deep wound, delayed wound healing | Will be assessed at 5 days, 2 weeks, 6 weeks post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | hematoma, seroma, infection, hypertrophic scarring | Will be tracked up until 3 months post-op |
| Sharp debridement | Need for any sharp debridement (office or OR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel H Park, MD | Contact | 434-327-2140 | rhp7gu@hscmail.mcc.virginia.edu |
| Name | Affiliation | Role |
|---|---|---|
| John T Stranix, MD | UVA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Medical Center | Recruiting | Charlottesville | Virginia | 22902 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41628614 | Derived | Park RH, Pawly J, Grogan G, DeVito RG, Ke BG, Behar BJ, Stranix JT. Topical Nitropaste Reduces Partial Free Nipple Graft Loss in Gender Affirming Mastectomy: A Randomized Controlled Trial. Plast Reconstr Surg. 2026 Feb 2. doi: 10.1097/PRS.0000000000012874. Online ahead of print. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2022 | May 24, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000068116 | Gender Dysphoria |
| ID | Term |
|---|---|
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D005996 | Nitroglycerin |
| D009824 | Ointments |
| ID | Term |
|---|---|
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Will be tracked up until 3 months post-op |
| Revision | Need for any revision | Will be tracked up until 3 months post-op |
| Readmission | 30 day ED or inpatient admission rate | Will be tracked 30 days |