Trial Outcomes & Findings for Topical Tranexamic Acid Use on Granulating Wounds Following Mohs Micrographic Surgery (NCT NCT04541303)

NCT ID: NCT04541303

Last Updated: 2024-11-21

Results Overview

Number of patients who call to report postoperative bleeding

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 124 participants
• Primary outcome timeframe: three days
• Results posted on: 2024-11-21

Participant Flow

Participant milestones

Measure	Intervention - Tranexamic Acid Topical application of tranexamic acid to granulating wound defect status post Mohs micrographic surgery. Tranexamic acid: tranexamic acid diluted to concentration of 25ml/mg	Placebo Topical application of normal saline to granulating wound defect status post Mohs micrographic surgery. normal saline: 0.9% sodium chloride
Overall Study STARTED	62	62
Overall Study COMPLETED	62	62
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Intervention n=62 Participants Topical application of tranexamic acid to granulating wound defect status post Mohs micrographic surgery. Tranexamic acid: tranexamic acid diluted to concentration of 25ml/mg	Placebo n=62 Participants Topical application of normal saline to granulating wound defect status post Mohs micrographic surgery. normal saline: 0.9% sodium chloride	Total n=124 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=62 Participants	0 Participants n=62 Participants	0 Participants n=124 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=62 Participants	6 Participants n=62 Participants	11 Participants n=124 Participants
Age, Categorical >=65 years	57 Participants n=62 Participants	56 Participants n=62 Participants	113 Participants n=124 Participants
Sex: Female, Male Female	19 Participants n=62 Participants	15 Participants n=62 Participants	34 Participants n=124 Participants
Sex: Female, Male Male	43 Participants n=62 Participants	47 Participants n=62 Participants	90 Participants n=124 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
bleeding	80 participants n=62 Participants	80 participants n=62 Participants	160 participants n=124 Participants

PRIMARY outcome

Timeframe: three days

Number of patients who call to report postoperative bleeding

Outcome measures

Measure	Intervention n=62 Participants Topical application of tranexamic acid to granulating wound defect status post Mohs micrographic surgery. Tranexamic acid: tranexamic acid diluted to concentration of 25ml/mg	Placebo n=62 Participants Topical application of normal saline to granulating wound defect status post Mohs micrographic surgery. normal saline: 0.9% sodium chloride
Frequency of Postoperative Hemorrhagic Complications	0 Participants	6 Participants

PRIMARY outcome

Timeframe: three days

The number of patients who return to clinic with postoperative bleeding

Outcome measures

Measure	Intervention n=62 Participants Topical application of tranexamic acid to granulating wound defect status post Mohs micrographic surgery. Tranexamic acid: tranexamic acid diluted to concentration of 25ml/mg	Placebo n=62 Participants Topical application of normal saline to granulating wound defect status post Mohs micrographic surgery. normal saline: 0.9% sodium chloride
Rate of Clinic Evaluations of Postoperative Hemorrhagic Complications	0 Participants	0 Participants

PRIMARY outcome

Timeframe: three days

The number of patients who are treated for postoperative bleeding

Outcome measures

Measure	Intervention n=62 Participants Topical application of tranexamic acid to granulating wound defect status post Mohs micrographic surgery. Tranexamic acid: tranexamic acid diluted to concentration of 25ml/mg	Placebo n=62 Participants Topical application of normal saline to granulating wound defect status post Mohs micrographic surgery. normal saline: 0.9% sodium chloride
Rate of Treatment Interventions for Postoperative Hemorrhagic Complications	0 Participants	1 Participants

SECONDARY outcome

Timeframe: three days

postoperative bleeding complications will be defined as arterial bleed, venous oozing, or organized blood clot/hematoma

Outcome measures

Measure	Intervention n=62 Participants Topical application of tranexamic acid to granulating wound defect status post Mohs micrographic surgery. Tranexamic acid: tranexamic acid diluted to concentration of 25ml/mg	Placebo n=62 Participants Topical application of normal saline to granulating wound defect status post Mohs micrographic surgery. normal saline: 0.9% sodium chloride
Types of Postoperative Hemorrhagic Complications	0 Participants	0 Participants

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brianna Castillo MD

Univ of Mo

Phone: 813-765-1619

Email: briannacastillo.md@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place