Postoperative bleeding and wound effusion from wounds created by tangential skin excision
Conditions
Interventions
Trade Name: Cyklokapron
Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion
Pharmaceutical form of the placebo: Solvent for solution for in
Sponsors
Department of Surgery, St Olav's University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients above 18 years of age to undergo split skin graft harvesting and hence getting a tangential superficial wound at the donor site, or patients who are to undergo tangential excisional revision of superficial wounds. 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: Patients who may be pregnant or who are nursing are not eligible for the study. Patients will receive a very low dose with tranexamic acid, of which a fraction can be expected to be absorbed systemically. As large studies have not found any increased risk of thromboembolic events or other adverse events from administering larger doses of tranexamic acid intravenously, we do not have any exclusion criteria for participation in the study due to fear of adverse effects. Patients who are known to be allergic to tranexamic acid will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Some patients can have extensive superficial wounds which leads to extensive blood loss and loss of body fluids and nutrients. Large burns, skin infections and trauma are examples. We want to investigate to what extent moistening the bandages covering these wounds with tranexamic acid 5 mg/ml may reduce both bleeding and wound effusions from these types of wounds, compared to moistening the bandage with saline. Patients with suitable wounds will have two equally large wound areas covered with dressing moistened with either active drug or placebo. Hence the patients will serve as their own controls, tangentially excised wounds are very identical, and few patients are needed for sufficient study power. The main objective is to measure bleeding and wound effusion as defined by change in bandage weight- 24 h and 72 h after the creation of the donor site wounds. ; Secondary Objective: A secondary objective is to register the time to spontaneous wound healing- to assess whether the topical application of tranexamic acid may influence the spontaneous healing process. ; Primary end point(s): Primary end point will be 1) the weight of the bandages on day 1 minus their weight when applied- the increase in weight reflects wound effusion (bleeding) first 24 hours. We will apply new bandages on day 1 and then register 2) Weight of bandages on day 3 minus weight when they were applied - the increase in weight reflects wound effusions between day 1-3. ;Timepoint(s) of evaluation of this end point: Weight of the bandages will be registered on day 0, day 1 and on day 3. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end points will be: 1) Any adverse reactions, complaints or observations that may suggest a reaction to the drug. 2) Time to full re-epithelialisation of the wound. ;Timepoint(s) of evaluation of this end point: Time to full healing of a split skin graft donor site will normally be 2-3 weeks. The patients will see the outpatient clinic at regular intervals until healing has occured. | — |
Countries
Norway
Contacts
Public ContactDept of plastic surgery, att: Ausen
Department of Surgery, St Olav's University Hospital
Outcome results
None listed