## Protocol Section
### Identification Module
**NCT ID:** NCT06428669

**Brief Title:** Effect of Nitropaste in Chest Masculinizing Surgery: Randomized, Prospective Trial

**Official Title:** The Effect of Nitropaste in Chest Masculinizing Surgery: Randomized, Prospective Trial

#### Organization Study ID Info
**ID:** HSR220217
#### Organization
**Class:** OTHER
**Full Name:** University of Virginia
### Status Module
#### Completion Date
**Date:** 2025-11

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-08-15

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Virginia

#### Responsible Party

**Investigator Affiliation:** University of Virginia

**Investigator Full Name:** John Stranix

**Investigator Title:** Assistant Professor, Department of Plastic Surgery

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** True

### Description Module

**Brief Summary:** 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.

**Detailed Description:** 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. We will conduct a prospective, randomized, single-blinded study where we will compare nitropaste vs. no nitropaste on mastectomy flaps. Nitropaste will be applied intraoperatively and 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.

### Conditions Module

**Conditions:**

- Gender Dysphoria

**Keywords:**

- Gender affirming surgery

- Chest masculinizing Surgery

- Nitropaste

- Wound healing

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 256

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Label:** No nitropaste group

**Type:** NO_INTERVENTION

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Drug: Nitro-Bid 2 % Topical Ointment

**Label:** Nitropaste group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Nitropaste group

**Description:** Intervention group will get 30mg of Nitro-Bid topical ointment applied over the chest (15mg/ 1 packet on each side) one time intra-operatively

**Name:** Nitro-Bid 2 % Topical Ointment

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Partial nipple graft loss (0-50%, 50% or more), Complete nipple graft loss

**Measure:** Free Nipple Graft

**Time Frame:** Will be assessed at 5 days, 2 weeks, 6 weeks post-op

**Description:** Superficial wound, deep wound, delayed wound healing

**Measure:** Wounds

**Time Frame:** Will be assessed at 5 days, 2 weeks, 6 weeks post-op

#### Secondary Outcomes

**Description:** hematoma, seroma, infection, hypertrophic scarring

**Measure:** Complications

**Time Frame:** Will be tracked up until 3 months post-op

**Description:** Need for any sharp debridement (office or OR)

**Measure:** Sharp debridement

**Time Frame:** Will be tracked up until 3 months post-op

**Description:** Need for any revision

**Measure:** Revision

**Time Frame:** Will be tracked up until 3 months post-op

**Description:** 30 day ED or inpatient admission rate

**Measure:** Readmission

**Time Frame:** Will be tracked 30 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Any adult (18 or older) patients of any gender identity who are undergoing chest masculinizing surgery with double incision and free nipple grafting.

Exclusion Criteria:

* Minor patients (younger than 18), anyone who's not getting free nipple grafting, anyone who's not utilizing double incision pattern, prisoners, anyone who is allergic to nitropaste, anyone who is taking phosphodiesterase inhibitor (ex)Sildenafil, tadalafil, vardenafil), anyone who's taking soluble guanylate cyclase stimulator riociguatdz

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** rhp7gu@hscmail.mcc.virginia.edu

**Name:** Rachel H Park, MD

**Phone:** 434-327-2140

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Charlottesville

**Contacts:**

***Contact 1:***

- **Email:** rhp7gu@hscmail.mcc.virginia.edu

- **Name:** Rachel H Park, MD

- **Phone:** 571-428-7278

- **Role:** CONTACT

**Country:** United States

**Facility:** University of Virginia Medical Center

**State:** Virginia

**Status:** RECRUITING

**Zip:** 22902

#### Overall Officials

**Official 1:**

**Affiliation:** UVA

**Name:** John T Stranix, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020018

- Term: Sexual Dysfunctions, Psychological

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M227

- Name: Gender Dysphoria

- Relevance: HIGH

- As Found: Gender Dysphoria

- ID: M21873

- Name: Sexual Dysfunctions, Psychological

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000068116

- Term: Gender Dysphoria

### Intervention Browse Module - Ancestors

- ID: D000014665

- Term: Vasodilator Agents

### Intervention Browse Module - Browse Branches

- Abbrev: VaDiAg

- Name: Vasodilator Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M9102

- Name: Nitroglycerin

- Relevance: HIGH

- As Found: Pre-natal

- ID: M17412

- Name: Vasodilator Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000005996

- Term: Nitroglycerin

### Misc Info Module

- Version Holder: 2024-05-31
