Topical Tranexamic Acid Use on Granulating Wounds Following Mohs Micrographic Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative Wound Haemorrhage

Intervention / Treatment
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* Drug: Tranexamic acid
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One arm will receive topical application of tranexamic acid (intervention). Other arm with receive topical application of normal saline (placebo).
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Topical application of tranexamic acid to granulating wound defect status post Mohs micrographic surgery. | Drug: Tranexamic acid<br>* tranexamic acid diluted to concentration of 25ml/mg<br>* Other names: Cyclokapron;|
| Placebo Comparator: Placebo<br>Topical application of normal saline to granulating wound defect status post Mohs micrographic surgery. | Drug: normal saline<br>* 0.9% sodium chloride<br>* Other names: 0.9% sodium chloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of postoperative hemorrhagic complications | number of patients who call with postoperative bleeding | three days | 
| Rate of clinic evaluations of postoperative hemorrhagic complications | number of patients who return to clinic with postoperative bleeding | three days | 
| Rate of treatment interventions for postoperative hemorrhagic complications | 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 | postoperative bleeding complications will be defined as arterial bleed, venous oozing, or organized blood clot/hematoma | three days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tranexamic acid, hemostasis, hemorrhagic complication, bleeding complication, Mohs micrographic surgery, granulating wound, granulating defect