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The Effect of Topical Tranexamic Acid on Postoperative Bleeding From Superficial Wounds

NCT02918201 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-11-28

No results posted yet for this study

Summary

After surgical procedures, interventions to reduce postoperative bleeding are of great importance. In this study, the effect will be investigated of administering tranexamic acid, which is designed for injection, directly onto the raw wound surface (topical application) created during surgery. In this way only a small amount of drug is to reach a large wound area. There will be a higher drug concentration of it in the exposed wound surface than after injection, but only a very low concentration in the body, and no risk of injury from needles. The researchers have recently shown that topically applicated tranexamic acid reduces bleeding in women who had two-sided breast reduction surgery. Now it will be studied whether topically applicated tranexamic acid reduces bleeding from superficial wounds, using as a study model the homogenous wounds created by tangential skin excision when harvesting split skin grafts for skin transplants. Two identical wound surfaces in the same patient will serve as case and control.

Conditions

  • Postoperative Hemorrhage
  • Injuries and Wounds

Interventions

DRUG

Tranexamic Acid

TXA 25 mg/ml applied topically to moisten the wound

DRUG

saline

Saline solution (0.9% NaCl) applied topically to moisten the wound

Sponsors & Collaborators

  • Haukeland University Hospital

    collaborator OTHER

  • St. Olavs Hospital

    lead OTHER

Principal Investigators

  • Birger Henning Endreseth, MD PhD · St Olavs Hospital Dept of Surgery

  • Hans Christian Sylvester Jensen, md phd · Haukeland University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02918201 on ClinicalTrials.gov