Skip to main content
OpenTrials
Completed

NCT Number: NCT04541303

Topical Tranexamic Acid Use on Granulating Wounds Following Mohs Micrographic Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Wound Haemorrhage

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Missouri-Columbia

Columbia, Missouri, 65212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tranexamic Acid

Drug

tranexamic acid diluted to concentration of 25ml/mg

Other names: Lysteda, Cyclokapron

normal saline

Drug

0.9% sodium chloride

Other names: 0.9% sodium chloride

Primary outcomes

  1. Frequency of Postoperative Hemorrhagic Complications

    Time frame: three days

    Number of patients who call to report postoperative bleeding

  2. Rate of Clinic Evaluations of Postoperative Hemorrhagic Complications

    Time frame: three days

    The number of patients who return to clinic with postoperative bleeding

  3. Rate of Treatment Interventions for Postoperative Hemorrhagic Complications

    Time frame: three days

    The number of patients who are treated for postoperative bleeding

Secondary outcomes

  1. Types of Postoperative Hemorrhagic Complications

    Time frame: three days

    postoperative bleeding complications will be defined as arterial bleed, venous oozing, or organized blood clot/hematoma

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 9, 2020
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.