Postoperative Wound Haemorrhage Clinical Trial
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
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.
| Status | Recruiting |
| Enrollment | 62 |
| Est. completion date | December 2021 |
| Est. primary completion date | December 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Missouri-Columbia | Columbia | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| University of Missouri-Columbia |
United States,
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Teoh WY, Tan TG, Ng KT, Ong KX, Chan XL, Hung Tsan SE, Wang CY. Prophylactic Topical Tranexamic Acid Versus Placebo in Surgical Patients: A Systematic Review and Meta-analysis*. Ann Surg. 2021 Apr 1;273(4):676-683. doi: 10.1097/SLA.0000000000003896. — View Citation
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* Note: There are 13 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of postoperative hemorrhagic complications | number of patients who call with postoperative bleeding | three days | |
| Primary | Rate of clinic evaluations of postoperative hemorrhagic complications | number of patients who return to clinic with postoperative bleeding | three days | |
| Primary | Rate of treatment interventions for postoperative hemorrhagic complications | number of patients who are treated for postoperative bleeding | three days | |
| Secondary | Types of postoperative hemorrhagic complications | postoperative bleeding complications will be defined as arterial bleed, venous oozing, or organized blood clot/hematoma | three days |