Clinical trial NCT04541303: Topical Tranexamic Acid Use on Granulating Wounds Following Mohs Micrographic Surgery
Official title: Randomized Study on the Topical Application of Tranexamic Acid to Wound Bed for Hemostasis in the Setting Granulating Wounds Following Mohs Micrographic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Postoperative Wound Haemorrhage
Keywords: tranexamic acid
hemostasis
hemorrhagic complication
bleeding complication
Mohs micrographic surgery
granulating wound
granulating defect
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One arm will receive topical application of tranexamic acid (intervention). Other arm with receive topical application of normal saline (placebo).
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of Postoperative Hemorrhagic Complications
timeFrame: three days
measure: Rate of Clinic Evaluations of Postoperative Hemorrhagic Complications
timeFrame: three days
measure: Rate of Treatment Interventions for Postoperative Hemorrhagic Complications
timeFrame: three days
Secondary outcomes:
measure: Types of Postoperative Hemorrhagic Complications
timeFrame: three days
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Nicholas Golda, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tolkachjov SN, Brodland DG, Coldiron BM, Fazio MJ, Hruza GJ, Roenigk RK, Rogers HW, Zitelli JA, Winchester DS, Harmon CB. Understanding Mohs Micrographic Surgery: A Review and Practical Guide for the Nondermatologist. Mayo Clin Proc. 2017 Aug;92(8):1261-1271. doi: 10.1016/j.mayocp.2017.04.009.
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