Clinical trial NCT06379724: Burn Study- Tranexamic Acid Versus Thrombin in Split Thickness Skin Graft
Official title: The Use of Topical Tranexamic Acid Versus Thrombin Spray for the Management of Split Thickness Skin Graft Recipient Site in Burn Management
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Burns
Skin Graft Complications
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, blinded, non-inferiority study
Primary purpose: TREATMENT

Brief summary: Investigators hypothesize that topical tranexamic acid will have better or comparable efficacy to topical thrombin in reducing hematoma formation at the wound base. The purpose of the study is to demonstrate that topical tranexamic acid will be a non-inferior alternative medication to the current standard of care,THROMBIN-JMI® , and at a lower cost to the health system.

Detailed description: 1. Enrolled subjects will be randomized to the control group or the tranexamic acid experimental group. Informed consent for study participation will be obtained by a team member preoperatively and informed consent for split thickness autografting will be obtained by a surgical team member. All questions will be answered and risk/benefits/alternatives will be explained in detail to the study subject. The subject will then be taken back to the operating room and anesthesia will be induced. The surgical timeout will occur verifying subject name, medical record number, planned operation, and surgical site. The subject will be prepped and draped in a sterile manner.
2. For the control group: The recipient burn site will be excised to healthy, bleeding tissue. The wound base is then sprayed with a film of THROMBIN-JMI® and covered with telfa and pressure applied for 10 minutes to achieve hemostasis while the skin graft is being harvested. The donor site will be marked to determine the size of the autograft. Tumescent solution with a local anesthetic and epinephrine is injected with a cannula and a split thickness skin graft will be taken at 1/12 inch using a Zimmer dermatome. Prior to application of the skin graft, a thin layer of thrombin is sprayed onto the wound base. The skin graft is then applied to the recipient site and fixated in standard fashion. The donor site and recipient site were dressed according to the preference of the attending physician. The patient will then awaken from anesthesia. This procedure will typically take between 60 to 120 minutes.
3. For the experimental groups: For the first phase of the study, the procedure described above was identical to that performed to the control group with the following exceptions: 100 milligram/milliliter, 10 milliliter vials x2 of injectable tranexamic acid will be filled into a 20 milliliter syringe with a spray tip. The tranexamic acid solution will be sprayed onto the wound base after excision and prior to skin graft appliance in the same manner as the thrombin spray in the control group.
4. Post-operatively, subjects will recover from anesthesia and continue routine post-operative care in the burn unit. The first assessment will occur at 48-72 hours after surgery at the first dressing change. Dressings will be changed by the nurse or burn technician who are all well-trained and experienced in burn wound care. Assessment will require documentation of hematoma occurrence, percent graft loss by measuring dimensions of non-adherent graft, and need for reoperation. If the graft is well adherent and the patient does not have barriers to discharge, the patient will be discharged and will return to clinic for follow up at post-operative day 7-10, and at 14 days. A second and third assessment will occur at this time by either the clinic medical provider or study team member. If the patient remains inpatient, the second and third assessment will be made in the hospital.

As part of the study, an objective measured hematoma rate and percent graft take will be measured rather than estimated at the 48-72 hours, 7-10 day, and 14 day follow up period which is the current protocol for this patient population.

Eligibility criteria: Inclusion Criteria:

* English or Spanish speaking
* Flame or scald burn injury
* \<=10% total body surface area (TBSA) partial thickness
* \<= 5% total body surface area (TBSA) deep partial or full thickness
* Skin graft harvested at 1/12 inch depth, meshed 1:1 or pie crusted if the area is a small functional area

Exclusion Criteria:

* \>10% total body surface area (TBSA) partial thickness burn
* \>5% total body surface area (TBSA )surgical area of burn injury (deep partial or full thickness injury)
* Traumatic or chemical burn mechanism
* Patients on immunosuppression
* Uncontrolled diabetes
* Known diagnosis of peripheral vascular disease or diagnosis at time of injury
* Pregnant women
* Patients with acquired defective color vision
* Patients with subarachnoid hemorrhage
* Patients with active intravascular clotting or known hypersensitivity reactions to tranexamic acid
* Inability to give informed consent

Primary outcomes:
measure: The number of participants with hematoma occurrence
timeFrame: Post-operative day fourteen, plus or minus two days
measure: The rate of percentage of graft take adherence amongst participants
timeFrame: Post-operative day fourteen, plus or minus two days
measure: Comparison of number of participants that require re-operation
timeFrame: Post-operative day fourteen, plus or minus two days
Secondary outcomes:
measure: Difference in cost between two hemostatic agents
timeFrame: during surgery
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The University of Kansas Health System
state: Kansas
Study officials:
affiliation: The University of Kansas Medical Center
name: Dhaval Bhavsar, MBBS
role: PRINCIPAL_INVESTIGATOR
References: