Topical Tranexamic Acid Use on Granulating Wounds Following Mohs Micrographic Surgery

October 9, 2024 updated by: Nicholas J Golda, University of Missouri-Columbia

Randomized Study on the Topical Application of Tranexamic Acid to Wound Bed for Hemostasis in the Setting 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

124

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri-Columbia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Topical application of tranexamic acid to granulating wound defect status post Mohs micrographic surgery.
Drug: Tranexamic acid
tranexamic acid diluted to concentration of 25ml/mg
Other Names:
  • Lysteda
  • Cyclokapron
Placebo Comparator: Placebo
Topical application of normal saline to granulating wound defect status post Mohs micrographic surgery.
Drug: normal saline
0.9% sodium chloride
Other Names:
  • 0.9% sodium chloride

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
three days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri-Columbia

Investigators

  • Principal Investigator: Nicholas Golda, MD, University of Missouri-Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2020

Primary Completion (Actual)

December 30, 2021

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

August 28, 2020

First Submitted That Met QC Criteria

September 3, 2020

First Posted (Actual)

September 9, 2020

Study Record Updates

Last Update Posted (Actual)

November 21, 2024

Last Update Submitted That Met QC Criteria

October 9, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025444

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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