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

Primary Purpose

Postoperative Hemorrhage, Injuries and Wounds

Status
Active
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Tranexamic Acid
saline
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Hemorrhage focused on measuring Administration, topical, Tranexamic Acid, Postoperative Care, Bandages, Occlusive Dressings

Eligibility Criteria

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

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. For those not capable of giving informed consent at the time of inclusion but included via next-of-kin, consent will be obtained or withdrawn when the patient is able to independently consider the inclusion

Exclusion Criteria:

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

Sites / Locations

  • Haukeland University Hospital, Burn Unit & Dept of Plastic Surgery
  • St Olavs Hospital, Kirurgisk klinikk

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

topical tranexamic acid

placebo control

Arm Description

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 Burn Unit at Haukeland University Hospital.

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 Burn Unit at Haukeland University Hospital.

Outcomes

Primary Outcome Measures

Postoperative bleeding
Bleeding will be determined by bandage weight increase

Secondary Outcome Measures

Area of innermost blood stain / area wound (ratio)
Number of layers with blood staining in the bandage
Time to re-epithelialization (complete healing) of the wound
to be registered as the wound change where there was no oozing in the bandages. This information will be extracted from the patient's medical record or from a patient telephone interview 3-4 weeks postoperatively if the wounds were followed elsewhere.
Postoperative complications related to the wound such as infection, allergic reactions or abnormal pain
Possible adverse effects reported by the patient

Full Information

First Posted
September 27, 2016
Last Updated
June 15, 2022
Sponsor
St. Olavs Hospital
Collaborators
Haukeland University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02918201
Brief Title
The Effect of Topical Tranexamic Acid on Postoperative Bleeding From Superficial Wounds
Official Title
The Effect of Topical Application of Tranexamic Acid on Postoperative Bleeding in Patients Undergoing Tangential Skin Excision
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
April 16, 2022 (Actual)
Study Completion Date
October 13, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Haukeland University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Hemorrhage, Injuries and Wounds
Keywords
Administration, topical, Tranexamic Acid, Postoperative Care, Bandages, Occlusive Dressings

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
topical tranexamic acid
Arm Type
Experimental
Arm Description
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 Burn Unit at Haukeland University Hospital.
Arm Title
placebo control
Arm Type
Placebo Comparator
Arm Description
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 Burn Unit at Haukeland University Hospital.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
Cyklokapron, TXA
Intervention Description
TXA 25 mg/ml applied topically to moisten the wound
Intervention Type
Drug
Intervention Name(s)
saline
Other Intervention Name(s)
NaCl
Intervention Description
Saline solution (0.9% NaCl) applied topically to moisten the wound
Primary Outcome Measure Information:
Title
Postoperative bleeding
Description
Bleeding will be determined by bandage weight increase
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
Area of innermost blood stain / area wound (ratio)
Time Frame
24 hours
Title
Number of layers with blood staining in the bandage
Time Frame
24 hours
Title
Time to re-epithelialization (complete healing) of the wound
Description
to be registered as the wound change where there was no oozing in the bandages. This information will be extracted from the patient's medical record or from a patient telephone interview 3-4 weeks postoperatively if the wounds were followed elsewhere.
Time Frame
4 weeks
Title
Postoperative complications related to the wound such as infection, allergic reactions or abnormal pain
Time Frame
3 days
Title
Possible adverse effects reported by the patient
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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. For those not capable of giving informed consent at the time of inclusion but included via next-of-kin, consent will be obtained or withdrawn when the patient is able to independently consider the inclusion Exclusion Criteria: pregnant or breastfeeding known allergy to tranexamic acid/Cyklokapron®
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birger Henning Endreseth, MD PhD
Organizational Affiliation
St Olavs Hospital Dept of Surgery
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hans Christian Sylvester Jensen, md phd
Organizational Affiliation
Haukeland University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Haukeland University Hospital, Burn Unit & Dept of Plastic Surgery
City
Bergen
Country
Norway
Facility Name
St Olavs Hospital, Kirurgisk klinikk
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
During up to 3 years after publication
IPD Sharing Access Criteria
On request and in cooperation with senior author for adequate interpretation of the material.

Learn more about this trial

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

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