Effect of Nitropaste in Chest Masculinizing Surgery
ConditionGender Dysphoria
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Virginia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Any adult (18 or older) patients of any gender identity who are undergoing chest masculinizing surgery with double incision and free nipple grafting.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Nitro-Bid 2 % Topical Ointment
DrugIntervention group will get 30mg of Nitro-Bid topical ointment applied over the chest (15mg/ 1 packet on each side) one time intra-operatively
Treatment groups
256 Participants
are divided into 2 treatment groupsGroup A: No nitropaste groupNo intervention 0 interventions
Group B: Nitropaste groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Free Nipple Graft Take
Rate of partial nipple graft loss (0-50%, 50% or more) or Complete nipple graft loss
Time frame
Will be assessed at 5 days, 2 weeks, 6 weeks post-op2
Wounds
Rate of superficial wound, deep wound, delayed wound healing
Time frame
Will be assessed at 5 days, 2 weeks, 6 weeks post-opSecondary outcomes
1
Complications
hematoma, seroma, infection, hypertrophic scarring
Time frame
Will be tracked up until 3 months post-op2
Sharp debridement
Need for any sharp debridement (office or OR)
Time frame
Will be tracked up until 3 months post-op3
Revision
Need for any revision
Time frame
Will be tracked up until 3 months post-op4
Readmission
30 day ED or inpatient admission rate
Time frame
Will be tracked 30 daysSponsors and contacts
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Source ClinicalTrials.gov