Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | 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. |
|
| Experimental | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | Drug | 100mg/mL 10mL vials x2 of injectable tranexamic acid will be filled into a 20 milliliter syringe with a spray tip. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of participants with hematoma occurrence | dichotomous endpoint | Post-operative day fourteen, plus or minus two days |
| The rate of percentage of graft take adherence amongst participants | continous endpoint | Post-operative day fourteen, plus or minus two days |
| Comparison of number of participants that require re-operation | dichotomous endpoint | Post-operative day fourteen, plus or minus two days |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in cost between two hemostatic agents | The cost comparison between two hemostatic agents | during surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Reynolds, BSN | Contact | 913-588-5000 | 0044 | jreynolds11@kumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Dhaval Bhavsar, MBBS | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Kansas Health System | Recruiting | Kansas City | Kansas | 66160 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D013917 | Thrombin |
| D016038 | Skin Transplantation |
| D014182 | Transplantation, Autologous |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Prospective, randomized, blinded, non-inferiority study
Not provided
Not provided
Subjects will be blinded to their randomization group. Study subject number will be linked to their randomization group. Blinding may be broken if the subject experiences an adverse reaction to the medication utilized for their group so that they are aware that they cannot receive the medication in the future. The research coordinator will have the code to the blind. The surgical team will not be blinded as the overall consistency of the topical agents will differ and may be apparent.
| Thrombin JMI | Drug | The wound base is then sprayed with a film of Thrombin-JMI |
|
|
| skin graft | Procedure | Skin is taken from uninjured part of the participant's body and used to surgically cover a wound or injured area with skin that contains the epidermis and a portion of the dermis. |
|
|
| D012697 |
| Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D062109 | Dermatologic Surgical Procedures |
| D019651 | Plastic Surgery Procedures |
| D013514 | Surgical Procedures, Operative |
| D014180 | Transplantation |