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Trial record 34 of 420 for:    TRANEXAMIC ACID

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

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ClinicalTrials.gov Identifier: NCT02918201
Recruitment Status : Not yet recruiting
First Posted : September 28, 2016
Last Update Posted : October 21, 2019
Sponsor:
Collaborator:
Haukeland University Hospital
Information provided by (Responsible Party):
St. Olavs Hospital

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.

Condition or disease Intervention/treatment Phase
Postoperative Hemorrhage Injuries and Wounds Drug: Tranexamic Acid Drug: saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Topical Application of Tranexamic Acid on Postoperative Bleeding and Wound Effusions in Patients Undergoing Tangential Skin Excision
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: topical tranexamic acid
bandages wetted in tranexamic acid solution to be applied on one of two superficial donor wounds on each participant. Potential candidates will be consecutively identified by the trial investigators among patients admitted to the plastic surgical department at St Olav's University Hospital and the burn unit at Haukeland University Hospital.
Drug: Tranexamic Acid
To moisten the innermost wound dressing with diluted tranexamic acid 5 mg/ml.
Other Name: Cyklokapron

Placebo Comparator: placebo control
bandages wetted in saline solution to be applied on one of two superficial donor wounds on each participant. Potential candidates will be consecutively identified by the trial investigators among patients admitted to the plastic surgical department at St Olav's University Hospital and the burn unit at Haukeland University Hospital.
Drug: saline
To moisten the innermost wound dressing with saline (0.9% NaCl)
Other Name: Cyklokapron




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Wound [ Time Frame: 3 days ]
    effusion as defined by bandage weight increase from 24 hours to 72 hours postoperatively

  2. Time to re-epithelialization [ Time Frame: 3 days ]
    Time to re-epithelialization of the wound

  3. Other postoperative complications [ Time Frame: 3 days ]
    Other postoperative complications related to the wound

  4. Possible adverse effects [ Time Frame: 3 days ]
    Possible adverse effects reported by the patient



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • to undergo split skin graft harvesting
  • two equally large and symmetrically distributed wounds can be defined in the donor area
  • received adequate oral and written information about the study and signed an informed-consent form

Exclusion Criteria:

  • pregnant or breastfeeding
  • known allergy to tranexamic acid/Cyklokapron®

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918201


Contacts
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Contact: Kjersti Ausen, MD +47 92249693 kjerstiausen@gmail.com
Contact: Hilde Pleym, MD PhD +47 90844763 hilde.pleym@stolav.no

Locations
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Norway
Haukeland University Hospital, Burn Unit & Dept of Plastic Surgery Not yet recruiting
Bergen, Norway
Contact: Ragnvald Brekke, md    +47 55975000      
Contact: Stian Almeland, md    +47 55975000      
St Olavs University Hospital, Plastic Surgery Dept Not yet recruiting
Trondheim, Norway, 7006
Contact: Kjersti Ausen, MD    +47 92249693    kjerstiausen@gmail.com   
Contact: Håvard Nordgård, md    +47 91717994      
Sponsors and Collaborators
St. Olavs Hospital
Haukeland University Hospital
Investigators
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Study Director: Petter Aadahl, MD PhD St. Olavs Hospital

Publications:
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Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT02918201     History of Changes
Other Study ID Numbers: 2016/831
2015-004342-26 ( EudraCT Number )
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Olavs Hospital:
Administration, topical
Tranexamic Acid
Postoperative Care
Bandages
Occlusive Dressings
Additional relevant MeSH terms:
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Tranexamic Acid
Hemorrhage
Postoperative Hemorrhage
Wounds and Injuries
Pathologic Processes
Postoperative Complications
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants