NCT04541303

Topical Tranexamic Acid Use on Granulating Wounds Following Mohs Micrographic Surgery

Randomized Study on the Topical Application of Tranexamic Acid to Wound Bed for Hemostasis in the Setting Granulating Wounds Following Mohs Micrographic Surgery

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Bleeding after Mohs micrographic surgery for skin cancer is a low risk complication that can occur. This study aims to determine the effect of a drug, often used to reduce bleeding, called tranexamic acid when applied topically to the skin wound after surgery.

Detailed description

To perform a prospective randomized controlled trial to determine the hemostatic effect of TXA soaked gauze (intervention) versus normal saline soaked gauze (control) when applied to granulating defects in the setting of Mohs micrographic surgery. Patients meeting inclusion criteria will be randomized into two arms once enrolled in the study on the day of their Mohs micrographic surgery (MMS). One arm will serve as the control group and will receive normal saline soaked telfa pads to the wound bed upon completion of MMS. A second arm will receive TXA 25mg/ml at a volume of 1ml/cm2 soaked telfa pads to wound bed upon completion of MMS. In both arms, the telfa pads will have a standard pressure dressing placed overtop.

Conditions

• Postoperative Wound Haemorrhage

Interventions

Type	Name	Description
DRUG	Tranexamic acid	tranexamic acid diluted to concentration of 25ml/mg
DRUG	normal saline	0.9% sodium chloride

Timeline

• Start date: 2020-10-08
• Primary completion: 2021-12-30
• Completion: 2021-12-30
• First posted: 2020-09-09
• Last updated: 2024-11-21
• Results posted: 2024-11-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study