Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06428669
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-20
Brief Title:
Effect of Nitropaste in Chest Masculinizing Surgery
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
The Effect of Nitropaste in Chest Masculinizing Surgery Randomized Prospective Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 theres 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 theres 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None