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Topical Tranexamic Acid Use on Granulating Wounds Following Mohs Micrographic Surgery

Primary Purpose

Postoperative Wound Haemorrhage

Status
Unknown status
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tranexamic acid
normal saline
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Wound Haemorrhage focused on measuring tranexamic acid, hemostasis, hemorrhagic complication, bleeding complication, Mohs micrographic surgery, granulating wound, granulating defect

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Missouri-ColumbiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 28, 2020
Last Updated
September 27, 2021
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT04541303
Brief Title
Topical Tranexamic Acid Use on Granulating Wounds Following Mohs Micrographic Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 8, 2020 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Wound Haemorrhage
Keywords
tranexamic acid, hemostasis, hemorrhagic complication, bleeding complication, Mohs micrographic surgery, granulating wound, granulating defect

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
One arm will receive topical application of tranexamic acid (intervention). Other arm with receive topical application of normal saline (placebo).
Masking
ParticipantCare ProviderInvestigator
Masking Description
Physician/surgeon, nurses, patient, and patient family will be blinded.
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Topical application of tranexamic acid to granulating wound defect status post Mohs micrographic surgery.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Topical application of normal saline to granulating wound defect status post Mohs micrographic surgery.
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Other Intervention Name(s)
Lysteda, Cyclokapron
Intervention Description
tranexamic acid diluted to concentration of 25ml/mg
Intervention Type
Drug
Intervention Name(s)
normal saline
Other Intervention Name(s)
0.9% sodium chloride
Intervention Description
0.9% sodium chloride
Primary Outcome Measure Information:
Title
Rate of postoperative hemorrhagic complications
Description
number of patients who call with postoperative bleeding
Time Frame
three days
Title
Rate of clinic evaluations of postoperative hemorrhagic complications
Description
number of patients who return to clinic with postoperative bleeding
Time Frame
three days
Title
Rate of treatment interventions for postoperative hemorrhagic complications
Description
number of patients who are treated for postoperative bleeding
Time Frame
three days
Secondary Outcome Measure Information:
Title
Types of postoperative hemorrhagic complications
Description
postoperative bleeding complications will be defined as arterial bleed, venous oozing, or organized blood clot/hematoma
Time Frame
three days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brianna Castillo, MD
Phone
5738824800
Email
bch4b@health.missouri.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Golda, MD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri-Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dyann Helming, APRN
Phone
573-882-8030
Email
helmingd@health.missouri.edu
First Name & Middle Initial & Last Name & Degree
Hope Gole, PhD
Phone
573-882-8030
Email
golehk@health.missouri.edu

12. IPD Sharing Statement

Citations:
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Citation
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Links:
URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022430s004lbl.pdf
Description
Ferring Pharmaceuticals Incorporated. Lysteda (tranexamic acid) [package insert]. Revised October 2013. Accessed May 2020.

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Topical Tranexamic Acid Use on Granulating Wounds Following Mohs Micrographic Surgery

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