External use of tranexamic acid to improve wound healing

Topical use of tranexamic acid for optimisation of wound healing in a novel, acute wound model

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001381-38-DK

Enrollment

Registered

2021-03-22

Start date

2021-08-30

Completion date

Unknown

Last updated

2023-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunomodulation of postoperative inflammatory reactions and thereby reduction of wound fluid production and improved healing by topical administration of tranexamic acid. MedDRA version: 20.0 Level: LLT Classification code 10002784 Term: Antifibrinolysis System Organ Class: 100000004865

Interventions

Trade Name: Tranexamic acid Product Name: tranexamic acid Pharmaceutical Form: Solution for injection INN or Proposed INN: Tranexamic acid CAS Number: 1197-18-8 Other descriptive name: TRANEXAMIC ACID

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All criteria must be met - Surgery where split thickness skin grafts are harvested - able patients - signed informed consent - Danish in writing and speech Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: - unable patients - Surgery where there wil not be harvested of split thickness skin grafts - Lacking signed informed consent - Immunological conditions, including autoimmune conditions such as rheumatoid arthritis, diabetes mellitus, inflammatory bowel disease, Lupus Erythematosus, Multiple Sclerosis, psoriasis

Design outcomes

Primary

Measure	Time frame
Main Objective: Tranexamic acid (TXA) is traditionally used to reduce per-and postoperative bleeding. The drug is applied IV or perorally, and most studies focus on reduction of bleeding. TXA is primarily known as an antifibrinolytic, less attention is paid to its immunomodulatory effects via plasmin inhibition. Attenuated postoperative inflammatory response could potentially reduce postoperative oedema, seroma formation, pain and wound healing complications. Topical administration of TXA provide low systemic absorbtion, reducing the risk of adverse effects. In this projcet we aim to investigate the immunomodulatory properties of TXA and and possible reduction of wound fluid production and thereby improvement of the post operative period in a novel wound model;Secondary Objective: not applicable;Primary end point(s): We aim to optimize the post operative period by topical application of tranexamic acid to a novel wound model We will measure the effect by performing growth factor profiling, inflammatory profiling, histopathological evaluation, microbiological analysis and planimetry of the wound model. This will be done by analysis of blood, fluid and tissue;Timepoint(s) of evaluation of this end point: Pre-operatively (baseline, blood samples) XML File Identifier: gx5jfH/YlFwIg1AeYoz8Sf3g7os= Page 12/21 Peroperatively (punch biopsy, planimetry) 80 min postoperatively (blood samples, wound fluid, planimetry) 7 (5-10) th day (punch biopsy, wound fluid, planimetry) 14 (12-16)th day (wound fluid, planimetry) Control after 3 months, coinciding with the ordinary surgical result control.	—

Measure

Time frame

Main Objective: Tranexamic acid (TXA) is traditionally used to reduce per-and postoperative bleeding. The drug is applied IV or perorally, and most studies focus on reduction of bleeding. TXA is primarily known as an antifibrinolytic, less attention is paid to its immunomodulatory effects via plasmin inhibition. Attenuated postoperative inflammatory response could potentially reduce postoperative oedema, seroma formation, pain and wound healing complications. Topical administration of TXA provide low systemic absorbtion, reducing the risk of adverse effects. In this projcet we aim to investigate the immunomodulatory properties of TXA and and possible reduction of wound fluid production and thereby improvement of the post operative period in a novel wound model;Secondary Objective: not applicable;Primary end point(s): We aim to optimize the post operative period by topical application of tranexamic acid to a novel wound model We will measure the effect by performing growth factor profiling, inflammatory profiling, histopathological evaluation, microbiological analysis and planimetry of the wound model. This will be done by analysis of blood, fluid and tissue;Timepoint(s) of evaluation of this end point: Pre-operatively (baseline, blood samples) XML File Identifier: gx5jfH/YlFwIg1AeYoz8Sf3g7os= Page 12/21 Peroperatively (punch biopsy, planimetry) 80 min postoperatively (blood samples, wound fluid, planimetry) 7 (5-10) th day (punch biopsy, wound fluid, planimetry) 14 (12-16)th day (wound fluid, planimetry) Control after 3 months, coinciding with the ordinary surgical result control.

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Secondary

Measure	Time frame
Secondary end point(s): We will register the following on every out-patient visit according to the time points • Status at the out-patient controls • Potential need for extra controls • Infection/complication • Haematoma/ bleeding • Need for revision • For how long follow up is needed -Pictures will be taken for the program imageJ for planimetry;Timepoint(s) of evaluation of this end point: Will be measured with the primary endpoints	—

Measure

Time frame

Secondary end point(s): We will register the following on every out-patient visit according to the time points • Status at the out-patient controls • Potential need for extra controls • Infection/complication • Haematoma/ bleeding • Need for revision • For how long follow up is needed -Pictures will be taken for the program imageJ for planimetry;Timepoint(s) of evaluation of this end point: Will be measured with the primary endpoints

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Countries

Denmark

Contacts

Public ContactPlast-og brystkirurgisk afdeling

Plastikkirurgisk og brystkirurgisk afdeling, Region Sjælland

isaltvig@gmail.com+46733644664

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026