Immunomodulation of postoperative inflammatory reactions and thereby reduction of wound seroma by topical administration of tranexamic acid. MedDRA version: 20.0 Level: LLT Classification code 10002784 Term: Antifibrinolysis System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Tranexamic acid
Product Name: tranexamic acid
Product Code: b02aa02
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Tranexamic acid
CAS Number: 1197-18-8
Other descriptive
Sponsors
Plastikkirurgisk og brystkirurgisk afdeling, Region Sjælland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All criteria must be filled - Patients scheduled for unilateral mastectomies - 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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: - unable patients - Procedures where there will not be preformed mastectomy without reconstruction. - 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 seroma formation after mastectomies and thereby improvement of the post operative period;Secondary Objective: na;Primary end point(s): We aim to optimize the post operative period by topical application of tranexamic acid to the surgical site after mastectomy We will measure the effect by performing growth factor profiling, inflammatory profiling, histopathological evaluation, microbiological analysis and planimetry of cikatrix. This will be done by analysis of blood, fluid and tissue;Timepoint(s) of evaluation of this end point: Pre-operatively (baseline) (blood samples) Peroperatively (punch biopsy, planimetry) XML File Identifier: sx2cTpGUVsQoj2aAg8nAhevbodk= Page 12/21 80 min postoperatively (blood samples, wound fluid, planimetry) 3 - 5 th day (punch biopsy, wound fluid, planimetry) 8-12 th day (punch biopsy, wound fluid, planimetry) Follow up after 3 months | — |
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: English Will be measured with the primary endpoints | — |
Countries
Denmark
Contacts
Public ContactPlast-og brystkirurgisk afdeling
Plastikkirurgisk og brystkirurgisk afdeling, Region Sjælland
Outcome results
None listed