Postoperative Wound Haemorrhage
Conditions
Keywords
tranexamic acid, hemostasis, hemorrhagic complication, bleeding complication, Mohs micrographic surgery, granulating wound, granulating defect
Brief summary
Bleeding after Mohs micrographic surgery for skin cancer is a low risk complication that can occur. This study aims to determine the effect of a drug, often used to reduce bleeding, called tranexamic acid when applied topically to the skin wound after surgery.
Detailed description
To perform a prospective randomized controlled trial to determine the hemostatic effect of TXA soaked gauze (intervention) versus normal saline soaked gauze (control) when applied to granulating defects in the setting of Mohs micrographic surgery. Patients meeting inclusion criteria will be randomized into two arms once enrolled in the study on the day of their Mohs micrographic surgery (MMS). One arm will serve as the control group and will receive normal saline soaked telfa pads to the wound bed upon completion of MMS. A second arm will receive TXA 25mg/ml at a volume of 1ml/cm2 soaked telfa pads to wound bed upon completion of MMS. In both arms, the telfa pads will have a standard pressure dressing placed overtop.
Interventions
DRUGTranexamic acid
tranexamic acid diluted to concentration of 25ml/mg
DRUGnormal saline
0.9% sodium chloride
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Physician/surgeon, nurses, patient, and patient family will be blinded.
Intervention model description
One arm will receive topical application of tranexamic acid (intervention). Other arm with receive topical application of normal saline (placebo).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All adult (18 years or older) patients presenting for Mohs micrographic surgery (MMS) for the treatment of melanoma or nonmelanoma skin cancer (NMSC) with a wound that will be healing by granulation
Exclusion criteria
* Patients must not be pregnant or breastfeeding. * Patients must not have a known allergic reaction or sensitivity to TXA * Patient must not have an international normalized ratio (INR) out of therapeutic range if on warfarin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Postoperative Hemorrhagic Complications | three days | Number of patients who call to report postoperative bleeding |
| Rate of Clinic Evaluations of Postoperative Hemorrhagic Complications | three days | The number of patients who return to clinic with postoperative bleeding |
| Rate of Treatment Interventions for Postoperative Hemorrhagic Complications | three days | The number of patients who are treated for postoperative bleeding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Types of Postoperative Hemorrhagic Complications | three days | postoperative bleeding complications will be defined as arterial bleed, venous oozing, or organized blood clot/hematoma |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Topical application of tranexamic acid to granulating wound defect status post Mohs micrographic surgery.
Tranexamic acid: tranexamic acid diluted to concentration of 25ml/mg | 62 |
| Placebo Topical application of normal saline to granulating wound defect status post Mohs micrographic surgery.
normal saline: 0.9% sodium chloride | 62 |
| Total | 124 |
Baseline characteristics
| Characteristic | Intervention | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 57 Participants | 56 Participants | 113 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 6 Participants | 11 Participants |
| bleeding | 80 participants | 80 participants | 160 participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 19 Participants | 15 Participants | 34 Participants |
| Sex: Female, Male Male | 43 Participants | 47 Participants | 90 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 62 | 0 / 62 |
| other Total, other adverse events | 0 / 62 | 0 / 62 |
| serious Total, serious adverse events | 0 / 62 | 0 / 62 |
Outcome results
Primary
Frequency of Postoperative Hemorrhagic Complications
Number of patients who call to report postoperative bleeding
Time frame: three days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Frequency of Postoperative Hemorrhagic Complications | 0 Participants |
| Placebo | Frequency of Postoperative Hemorrhagic Complications | 6 Participants |
p-value: 0.028None specified
Primary
Rate of Clinic Evaluations of Postoperative Hemorrhagic Complications
The number of patients who return to clinic with postoperative bleeding
Time frame: three days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Rate of Clinic Evaluations of Postoperative Hemorrhagic Complications | 0 Participants |
| Placebo | Rate of Clinic Evaluations of Postoperative Hemorrhagic Complications | 0 Participants |
Primary
Rate of Treatment Interventions for Postoperative Hemorrhagic Complications
The number of patients who are treated for postoperative bleeding
Time frame: three days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Rate of Treatment Interventions for Postoperative Hemorrhagic Complications | 0 Participants |
| Placebo | Rate of Treatment Interventions for Postoperative Hemorrhagic Complications | 1 Participants |
Secondary
Types of Postoperative Hemorrhagic Complications
postoperative bleeding complications will be defined as arterial bleed, venous oozing, or organized blood clot/hematoma
Time frame: three days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Types of Postoperative Hemorrhagic Complications | 0 Participants |
| Placebo | Types of Postoperative Hemorrhagic Complications | 0 Participants |