Topical Tranexamic Acid Use on Granulating Wounds Following Mohs Micrographic Surgery

Sponsor

University of Missouri-Columbia (Other)

Overall Status

Recruiting

CT.gov ID

NCT04541303

Collaborator

(none)

Enrollment

Location

Arms

13.8

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Wound Haemorrhage	Drug: Tranexamic acid Drug: normal saline	Early Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

One arm will receive topical application of tranexamic acid (intervention). Other arm with receive topical application of normal saline (placebo).One arm will receive topical application of tranexamic acid (intervention). Other arm with receive topical application of normal saline (placebo).

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

Physician/surgeon, nurses, patient, and patient family will be blinded.

Primary Purpose:

Prevention

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

Actual Study Start Date :

Oct 8, 2020

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Rate of postoperative hemorrhagic complications [three days]
number of patients who call with postoperative bleeding
Rate of clinic evaluations of postoperative hemorrhagic complications [three days]
number of patients who return to clinic with postoperative bleeding
Rate of treatment interventions for postoperative hemorrhagic complications [three days]
number of patients who are treated for postoperative bleeding

Secondary Outcome Measures

Types of postoperative hemorrhagic complications [three days]
postoperative bleeding complications will be defined as arterial bleed, venous oozing, or organized blood clot/hematoma

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.