NCT02918201

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
3.3 years until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

2.5 years

First QC Date

September 27, 2016

Last Update Submit

November 22, 2023

Conditions

Postoperative HemorrhageInjuries and Wounds

Keywords

Administration, topicalTranexamic AcidPostoperative CareBandagesOcclusive Dressings

Outcome Measures

Primary Outcomes (1)

  • Postoperative bleeding

    Bleeding will be determined by bandage weight increase

    24 hours postoperatively

Secondary Outcomes (5)

  • Area of innermost blood stain / area wound (ratio)

    24 hours

  • Number of layers with blood staining in the bandage

    24 hours

  • Time to re-epithelialization (complete healing) of the wound

    4 weeks

  • Postoperative complications related to the wound such as infection, allergic reactions or abnormal pain

    3 days

  • Possible adverse effects reported by the patient

    3 days

Study Arms (2)

topical tranexamic acid

EXPERIMENTAL

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.

Drug: Tranexamic Acid

placebo control

PLACEBO COMPARATOR

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.

Drug: saline

Interventions

Tranexamic AcidDRUG

TXA 25 mg/ml applied topically to moisten the wound

Also known as: Cyklokapron, TXA
topical tranexamic acid
salineDRUG

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

Also known as: NaCl
placebo control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to undergo split skin graft harvesting
  • two equally large and symmetrically distributed wounds can be defined in the donor area

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Haukeland University Hospital, Burn Unit & Dept of Plastic Surgery

Bergen, Norway

Location

St Olavs Hospital, Kirurgisk klinikk

Trondheim, Norway

Location

MeSH Terms

Conditions

Postoperative HemorrhageWounds and Injuries

Interventions

Tranexamic AcidSodium Chloride

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Birger Henning Endreseth, MD PhD

    St Olavs Hospital Dept of Surgery

    STUDY DIRECTOR

  • Hans Christian Sylvester Jensen, md phd

    Haukeland University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2016

First Posted

September 28, 2016

Study Start

January 1, 2020

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

The results are to be pulished in a suitable peer-reviewed international journal and to be presented at national and international relevant scientific meetings

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
During up to 3 years after publication
Access Criteria
On request and in cooperation with senior author for adequate interpretation of the material.

Locations

NO(2)