- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02918201
The Effect of Topical Tranexamic Acid on Postoperative Bleeding From Superficial Wounds
The Effect of Topical Application of Tranexamic Acid on Postoperative Bleeding in Patients Undergoing Tangential Skin Excision
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
One or more paired donor sites will be created for each patient using the Zimmer dermatome. Paired wounds withcomparable size, depth, and location and will be labeled "A" and "B." A study nurse not involved in the operation will prepare two identical vials of 20 ml saline, marking them "A" and "B." A sealed numbered study envelope will state which vial should receive TXA. In the study drug vial, 5 ml will be replaced with 5 ml of 100 mg/ml TXA, yielding a solution of 25 mg/ml TXA. Both vials will receive 0,1 ml epinephrine 1 mg/ml, yielding an epinephrine concentration of 5 µg/ml to match the hemostatic saline-epinephrine solution applied topically to donor wounds at the burn center. The sets of vials and the corresponding study ID numbers will be delivered to the operating theatre. Prior to bandaging, the respective study wounds will be moistened with the corresponding study fluid. Gloves will be changed between each application to avoid cross-contamination. The study wounds will then be covered with an innermost non-absorbent layer of Vaseline gauze and five dry surgical gauzes to absorb the blood and exudate. The weight of a single dry gauze is consistent (27.5 g). The dressings will be marked "A" and "B" according to the drug vials used.
On the first postoperative day, the dressings will be removed except for the innermost Vaseline gauze. The wound surface area and the area of the blood stain on the innermost gauze will be measured. Dressing weight gain will be calculated by weighing the five dry gauzes and subtracting the dry weight (137.5 g). The paired gauzes will be visually compared for bleeding.and photo documented for later direct comparison.
During the first 24 h and over the following days and weeks, the participants will be monitored for possible adverse events, postoperative complications, and time to re-epithelialization.
Randomization Computer-generated randomization, production of corresponding sealed study envelopes, and organization of electronic case report forms will be provided by the Clinical Research Unit of St. Olav's University Hospital, Trondheim, Norway. Randomization instructions will be executed by a study nurse who was otherwise not connected to surgical procedures or patient follow-ups. All participants and personnel involved in surgery, follow-up, data collection, and statistical analysis will be blinded to the randomization.
Study end points The primary endpoint will be postoperative bleeding, defined as the net weight gain of the dressings per wound area. The secondary endpoints will be blood stain to wound area ratio and visual comparison of the amount of blood between paired dressings. All variables will be recorded on the first postoperative day. Additional secondary outcomes will be time to re-epithelialization, defined as no oozing in the dressings, and the occurrence of complications, such as wound infections and thromboembolic events.
Statistical analysis A ≥ 25 % reduction in bleeding in TXA donor wounds will be considered clinically significant. A delay in healing time or an increase in infection rate of ≥ 25 % will be considered clinically significant. The standard deviation (SD) was uncertain, as few similar studies exist but were estimated to be 0.4, based on previous effect studies22,23. As each patient will be his or her own control, using a paired samples t-test to detect a difference of 0.25, and a standard deviation of 0.4, α of 0.05, and power of 0.80, a sample size of 23 wound pairs is needed (power calculation. http://www.biomath.info/power/prt.htm25). We choose to include a total of 36 wound pairs for additional power in case of technical difficulties, since previous effect studies do not use the surrogate variables for bleeding used in this study. Continuous data will be analyzed using the paired samples t-test for normally distributed data and Wilcoxon signed rank test for non-normally distributed data. Categorical data will be analyzed using the chi-squared test.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Bergen, Norway
- Haukeland University Hospital, Burn Unit & Dept of Plastic Surgery
-
Trondheim, Norway
- St Olavs Hospital, Kirurgisk klinikk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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®
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: topical tranexamic acid
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.
|
TXA 25 mg/ml applied topically to moisten the wound
Other Names:
|
Placebo Comparator: placebo control
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.
|
Saline solution (0.9% NaCl) applied topically to moisten the wound
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative bleeding
Time Frame: 24 hours postoperatively
|
Bleeding will be determined by bandage weight increase
|
24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to re-epithelialization (complete healing) of the wound
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Area of innermost blood stain / area wound (ratio)
Time Frame: 24 hours
|
The area of the innermost blood stain and the wound area will be measured in cm2, and the ratio between the two areas will be calculated.
|
24 hours
|
Number of layers with blood staining in the bandage
Time Frame: 24 hours
|
One will count the number of bandage layers with oozing
|
24 hours
|
Postoperative complications related to the wound such as infection, allergic reactions or abnormal pain
Time Frame: 3 days
|
Any of the mentioned events will be registeres as a postoperative complication
|
3 days
|
Possible adverse effects reported by the patient
Time Frame: 3 days
|
Any possible adverse effects reported by the patient will be registered.
|
3 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Birger Henning Endreseth, MD PhD, St Olavs Hospital Dept of Surgery
- Study Director: Hans Christian Sylvester Jensen, md phd, Haukeland University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/6808
- 2015-004342-26 (EudraCT Number)
- 2016/831 (Other Identifier: REK-midt)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postoperative Hemorrhage
-
CytoSorbents, IncCompletedBlood Loss, Surgical | Blood Loss, Postoperative | Hemorrhage, Surgical | Hemorrhage PostoperativeUnited States, Canada
-
CytoSorbents, IncTerminatedBlood Loss, Surgical | Blood Loss, Postoperative | Hemorrhage, Surgical | Hemorrhage PostoperativeUnited States
-
CytoSorbents, IncRecruitingBlood Loss, Surgical | Blood Loss, Postoperative | Hemorrhage, Surgical | Hemorrhage PostoperativeGermany, Belgium, United Kingdom, Austria, Sweden
-
University of LiegeCompletedArthroplasty Complications | Hemorrhage Postoperative | Total Blood LossBelgium
-
Johann Wolfgang Goethe University HospitalCompletedPostoperative BloodlossGermany
-
San Filippo Neri General HospitalCompletedPostoperative Hemorrhages
-
St. Mary's Research Center, CanadaNot yet recruiting
-
Firat UniversityCompleted
-
Medical University of GrazCompletedPostoperative BleedingAustria
-
Chiang Mai UniversityCompletedBlood Loss, Postoperative
Clinical Trials on Tranexamic Acid
-
Icahn School of Medicine at Mount SinaiRecruiting
-
Samsung Medical CenterUnknownBleeding | Transfusion Related ComplicationKorea, Republic of
-
University of LiegeCompletedArthroplasty Complications | Hemorrhage Postoperative | Total Blood LossBelgium
-
London School of Hygiene and Tropical MedicineCompleted
-
Assiut UniversityCompleted
-
Thammasat UniversityCompleted
-
Ferring PharmaceuticalsCompleted
-
Ain Shams UniversityCompleted
-
Aswan University HospitalCompletedCesarean Section ComplicationsEgypt
-
London School of Hygiene and Tropical MedicineRawalpindi Medical CollegeCompletedPregnancy, High RiskPakistan, Zambia