Topical Tranexamic Acid Use on Granulating Wounds Following Mohs Micrographic Surgery

University of Missouri (MU)

Status and phase: Completed; Early Phase 1

Conditions: Postoperative Wound Haemorrhage

Treatments: Drug: Tranexamic acid; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04541303

2025444

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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124 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

Topical application of tranexamic acid to granulating wound defect status post Mohs micrographic surgery.

Treatment:

Drug: Tranexamic acid

Placebo

Placebo Comparator group

Description:

Topical application of normal saline to granulating wound defect status post Mohs micrographic surgery.

Treatment:

Drug: normal saline