Topical Tranexamic Acid Use on Granulating Wounds Following Mohs Micrographic Surgery

Early Phase 1

Completed

• Conditions: Postoperative Wound Haemorrhage
• Interventions: Drug: normal saline; Drug: Tranexamic acid

• Registration Number: NCT04541303
• Lead Sponsor: University of Missouri-Columbia

Brief 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.

Study Timeline

• Study First Submitted: 2020-08-28
• Study First Submitted QC: 2020-09-03
• Study First Posted: 2020-09-09
• Study Start: 2020-10-08
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30
• Results First Submitted: 2023-05-16
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-09
• Last Update Submitted: 2024-10-09
• Results First Posted: 2024-11-21
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• All adult (18 years or older) patients presenting for Mohs micrographic surgery (MMS) for the treatment of melanoma or nonmelanoma skin cancer (NMSC) with a wound that will be healing by granulation

Exclusion Criteria

• Patients must not be pregnant or breastfeeding.
• Patients must not have a known allergic reaction or sensitivity to TXA
• Patient must not have an international normalized ratio (INR) out of therapeutic range if on warfarin.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	normal saline	Topical application of normal saline to granulating wound defect status post Mohs micrographic surgery.
Intervention	Tranexamic acid	Topical application of tranexamic acid to granulating wound defect status post Mohs micrographic surgery.

Primary Outcome Measures

Name	Time	Method
Frequency of Postoperative Hemorrhagic Complications	three days	Number of patients who call to report postoperative bleeding
Rate of Clinic Evaluations of Postoperative Hemorrhagic Complications	three days	The number of patients who return to clinic with postoperative bleeding
Rate of Treatment Interventions for Postoperative Hemorrhagic Complications	three days	The number of patients who are treated for postoperative bleeding

Secondary Outcome Measures

Name	Time	Method
Types of Postoperative Hemorrhagic Complications	three days	postoperative bleeding complications will be defined as arterial bleed, venous oozing, or organized blood clot/hematoma

Trial Locations

Locations (1)

University of Missouri-Columbia; 🇺🇸 Columbia, Missouri, United States