Using Nitropaste to Improve Healing After Chest Masculinizing Surgery
The Effect of Nitropaste in Chest Masculinizing Surgery: Randomized, Prospective Trial
This study is testing if using Nitropaste can help adults heal better and have fewer problems after chest masculinizing surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 256 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Virginia Academic / other |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT06428669 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of Nitropaste, a topical agent containing 2% nitroglycerin, to reduce wound complications in patients undergoing chest masculinizing surgery. The research will be conducted as a prospective, randomized, single-blinded trial comparing outcomes between patients receiving Nitropaste and those who do not. Participants will be adults undergoing surgery with a double incision and free nipple grafting technique, and follow-up assessments will occur at specified intervals post-operation. The primary outcome will focus on the condition of the surgical site and any complications that arise.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older who are undergoing chest masculinizing surgery with double incision and free nipple grafting.
Not a fit: Patients who are minors, not undergoing free nipple grafting, or those with specific contraindications such as allergies to nitropaste will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce wound complications and improve recovery for patients undergoing chest masculinizing surgery.
How similar studies have performed: While there have been studies showing the effectiveness of Nitropaste in other surgical contexts, this specific application in chest masculinizing surgery is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Charlottesville, Virginia
- University of Virginia Medical Center — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: John T Stranix, MD — Uva
- Study coordinator: Rachel H Park, MD
- Email: rhp7gu@hscmail.mcc.virginia.edu
- Phone: 434-327-2140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.