Early Phase 1
N=124
Topical Tranexamic Acid Use on Granulating Wounds Following Mohs Micrographic Surgery
Postoperative Wound Haemorrhage
Bottom Line
View on ClinicalTrials.gov: NCT04541303 ↗Enrolled (actual)
124
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Frequency of Postoperative Hemorrhagic Complications — 0; 6 Participants — p=.028
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Tranexamic acid (Drug); normal saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Missouri-Columbia
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Postoperative Hemorrhagic Complications |
0; 6 | .028 sig |
| PRIMARY Rate of Clinic Evaluations of Postoperative Hemorrhagic Complications |
0; 0 | — |
| PRIMARY Rate of Treatment Interventions for Postoperative Hemorrhagic Complications |
0; 1 | — |
| SECONDARY Types of Postoperative Hemorrhagic Complications |
0; 0 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04541303). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.