Clinical Trial: The Effect of Topical Tranexamic Acid on Postoperative Bleeding and Effusions From Superficial Wounds

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: The Effect of Topical Application of Tranexamic Acid on Postoperative Bleeding and Wound Effusions in Patients Undergoing Tangential Skin Excision

Brief 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 and wound effusions 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.

Detailed Summary:
Sponsor: St. Olavs Hospital

Current Primary Outcome: Postoperative bleeding as defined by bandage weight increase after the first 24 hours [ Time Frame: 24 hours postoperatively ]

Bleeding/wound oozing will be determined by weighing the bandages at predefined time intervals


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Wound [ Time Frame: 3 days ]
    effusion as defined by bandage weight increase from 24 hours to 72 hours postoperatively
  • Time to re-epithelialization [ Time Frame: 3 days ]
    Time to re-epithelialization of the wound
  • Other postoperative complications [ Time Frame: 3 days ]
    Other postoperative complications related to the wound
  • Possible adverse effects [ Time Frame: 3 days ]
    Possible adverse effects reported by the patient


Original Secondary Outcome:

  • Wound effusion as defined by bandage weight increase from 24 hours to 72 hours postoperatively [ Time Frame: 3 days ]
  • Time to re-epithelialization of the wound [ Time Frame: 3 days ]
  • Other postoperative complications related to the wound [ Time Frame: 3 days ]
  • Possible adverse effects reported by the patient [ Time Frame: 3 days ]


Information By: St. Olavs Hospital

Dates:
Date Received: September 27, 2016
Date Started: June 2017
Date Completion: August 2018
Last Updated: March 6, 2017
Last Verified: March 2017