HealthyNCT07807371
Timing of Subcutaneous Tranexamic Acid Injection in Mohs Micrographic Surgery
A study testing Subcutaneous TXA injection before reconstruction and Subcutaneous TXA injection after reconstruction in people with Healthy, run by Cooper Norcross Health.
Trial summary
This study will compare postoperative bleeding after subcutaneous tranexamic acid (TXA) is administered during Mohs surgery either after tumor clearance and before reconstruction or after reconstruction and before bandage application. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Subcutaneous TXA injection before reconstruction and Subcutaneous TXA injection after reconstruction
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Undergoing MMS at a participating site with a planned same-day linear closure, flap reconstruction, or graft reconstruction.
- Willing and able to provide written informed consent.
- Able to participate in standard postoperative follow-up and to be reached if follow-up clarification is required.
Who cannot join
- Known allergy or hypersensitivity to TXA.
- Active deep-vein thrombosis, pulmonary embolism, stroke, myocardial infarction, or other active thromboembolic event at the time of surgery.
- Thromboembolic event within the previous 3 months.
- Systolic blood pressure greater than 200 mmHg at the time of surgery.
- Pregnancy or breastfeeding.
- Planned second-intention healing without reconstruction.
Show all 10Show fewer
- History of seizures or current medication judged by the investigator to materially lower seizure threshold.
- Reported serum creatinine of 5 mg/dL or greater.
- Unable to complete the 48-hour outcome assessment or standard postoperative follow-up.
- Prior enrollment in this study.
About this study
Official title: Timing of Subcutaneous Tranexamic Acid Injection in Mohs Micrographic Surgery: A Prospective, Multicenter, Two-Arm, Non-Inferiority Trial
This study will compare postoperative bleeding after subcutaneous tranexamic acid (TXA) is administered during Mohs surgery either after tumor clearance and before reconstruction or after reconstruction and before bandage application. TXA is a medication already being administered selectively during Mohs to help lessen bleeding. Enrollment will be enriched for patients taking anticoagulant or antiplatelet therapy and for patients receiving flaps or grafts because these groups have higher bleeding risk; although, any patient receiving Mohs with a linear closure, flap, or graft, may enroll. The primary hypothesis is that pre-reconstruction TXA is no better or worse compared to post-reconstruction TXA when measuring bleeding events within 48 hours and surgical complications within 30 days.
- Conditions
- Healthy
- Being tested
- Subcutaneous TXA injection before reconstruction, Subcutaneous TXA injection after reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous TXA injection before reconstructionDrug
Subcutaneous TXA injection before reconstruction
Subcutaneous TXA injection after reconstructionDrug
Subcutaneous TXA injection after reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous TXA prior to reconstruction | Active comparator | Subcutaneous TXA prior to reconstruction Receives: Drug: Subcutaneous TXA injection before reconstruction |
| Subcutaneous TXA after reconstruction | Active comparator | Subcutaneous TXA after reconstruction Receives: Drug: Subcutaneous TXA injection after reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of bleeding events 48 hours after surgery measured via documentation in electronic medical record (phone calls, urgent care/office visits for bleeding control)
Determine whether pre-reconstruction TXA is non-inferior to post-reconstruction TXA for a composite bleeding event within 48 hours after surgery.
Measured: 48 hours post procedure
Secondary outcomes (2)
Compare wound safety outcomes, including dehiscence, infection, and, where applicable, partial or complete flap/graft necrosis. This will be measured via photograph submission at 7-14 days and chart review for phone calls/office in 30 days
Compare wound safety outcomes through 30 days, including dehiscence, infection, and, where applicable, partial or complete flap/graft necrosis.
Measured: 30 days
Compare thromboembolic events through 30 days by chart review
Compare thromboembolic events through 30 days by chart review
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cooper Norcross Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naomi Lawrence, Cooper Norcross Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807371
- Sponsor's protocol ID
- 26-226
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kane Z, Picetti R, Wilby A, Standing JF, Grassin-Delyle S, Roberts I, Shakur-Still H. Physiologically based modelling of tranexamic acid pharmacokinetics following intravenous, intramuscular, sub-cutaneous and oral administration in healthy volunteers. Eur J Pharm Sci. 2021 Sep 1;164:105893. doi: 10.1016/j.ejps.2021.105893. Epub 2021 Jun 1.
PubMed 34087356Kumar EA, Morris LM, Michalski-McNeely BM. Tranexamic Acid in Mohs Micrographic Surgery: A Systematic Review. Dermatol Surg. 2025 Jan 1;51(1):17-19. doi: 10.1097/DSS.0000000000004373. Epub 2024 Sep 5.
PubMed 39235116Zilinsky I, Barazani TB, Visentin D, Ahuja K, Martinowitz U, Haik J. Subcutaneous Injection of Tranexamic Acid to Reduce Bleeding During Dermatologic Surgery: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial. Dermatol Surg. 2019 Jun;45(6):759-767. doi: 10.1097/DSS.0000000000001786.
PubMed 30640775Perz AM, Lukowiak TM, Lee MP, Neal D, Aizman L, Miller CJ, Golda N, Albertini JG, Holmes T, Bar A, Leitenberger J, Maher I, Sobanko JF, Chen D, Hollmig T, Aasi S, Sutton A, Higgins HW 2nd, Shin TM, Weinberger C, Mattox A, Wysong A, Etzkorn JR. Postoperative Complications After Interpolated Flap Repair for Mohs Defects of the Nose: A Multicenter Prospective Cohort Study. Dermatol Surg. 2023 Feb 1;49(2):135-139. doi: 10.1097/DSS.0000000000003653. Epub 2022 Dec 22.
PubMed 36728063Alam M, Ibrahim O, Nodzenski M, Strasswimmer JM, Jiang SI, Cohen JL, Albano BJ, Batra P, Behshad R, Benedetto AV, Chan CS, Chilukuri S, Crocker C, Crystal HW, Dhir A, Faulconer VA, Goldberg LH, Goodman C, Greenbaum SS, Hale EK, Hanke CW, Hruza GJ, Jacobson L, Jones J, Kimyai-Asadi A, Kouba D, Lahti J, Macias K, Miller SJ, Monk E, Nguyen TH, Oganesyan G, Pennie M, Pontius K, Posten W, Reichel JL, Rohrer TE, Rooney JA, Tran HT, Poon E, Bolotin D, Dubina M, Pace N, Kim N, Disphanurat W, Kathawalla U, Kakar R, West DP, Veledar E, Yoo S. Adverse events associated with mohs micrographic surgery: multicenter prospective cohort study of 20,821 cases at 23 centers. JAMA Dermatol. 2013 Dec;149(12):1378-85. doi: 10.1001/jamadermatol.2013.6255.
PubMed 24080866Freeman SC, Heath MS, Neill B, Morris C, Lucero OM, Yu W, Bar A, Leitenberger JJ. Tranexamic Acid Prevention of Hemorrhagic Complications Following Interpolated Flap Repair: A Single-Center, Retrospective, Cohort Study. Dermatol Surg. 2023 Dec 1;49(12):1139-1142. doi: 10.1097/DSS.0000000000003931. Epub 2023 Sep 14.
PubMed 37712760Wang W, Lee J, Qin S, Brown MD, Doerr T. Indications and Outcomes of Mohs Micrographic Surgery Using a Multidisciplinary Approach: A Decade of Experience. Dermatol Surg. 2021 Jan 1;47(1):10-15. doi: 10.1097/DSS.0000000000002467.
PubMed 32541342
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Subcutaneous Tranexamic Acid Injection in Mohs Micrographic Surgery: A Prospective, Multicenter, Two-Arm, Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT07807371
- Acronym / sponsor ID
- 26-226
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Cooper Norcross HealthUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare postoperative bleeding after subcutaneous tranexamic acid (TXA) is administered during Mohs surgery either after tumor clearance and before reconstruction or after reconstruction and before bandage application. TXA is a medication already being administered selectively during Mohs to help lessen bleeding. Enrollment will be enriched for patients taking anticoagulant or antiplatelet therapy and for patients receiving flaps or grafts because these groups have higher bleeding risk; although, any patient receiving Mohs with a linear closure, flap, or graft, may enroll. The primary hypothesis is that pre-reconstruction TXA is no better or worse compared to post-reconstruction TXA when measuring bleeding events within 48 hours and surgical complications within 30 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous TXA prior to reconstruction | Active comparator | Drug: Subcutaneous TXA injection before reconstructionSubcutaneous TXA prior to reconstruction |
| Subcutaneous TXA after reconstruction | Active comparator | Drug: Subcutaneous TXA injection after reconstructionSubcutaneous TXA after reconstruction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older.
- Undergoing MMS at a participating site with a planned same-day linear closure, flap reconstruction, or graft reconstruction.
- Willing and able to provide written informed consent.
- Able to participate in standard postoperative follow-up and to be reached if follow-up clarification is required.
Key exclusion criteria (10 listed)
- Known allergy or hypersensitivity to TXA.
- Active deep-vein thrombosis, pulmonary embolism, stroke, myocardial infarction, or other active thromboembolic event at the time of surgery.
- Thromboembolic event within the previous 3 months.
- Systolic blood pressure greater than 200 mmHg at the time of surgery.
- Pregnancy or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subcutaneous TXA injection before reconstructionSubcutaneous TXA injection before reconstruction | Drug | Subcutaneous TXA prior to reconstruction |
| Subcutaneous TXA injection after reconstructionSubcutaneous TXA injection after reconstruction | Drug | Subcutaneous TXA after reconstruction |
Primary outcome
Quantity of bleeding events 48 hours after surgery measured via documentation in electronic medical record (phone calls, urgent care/office visits for bleeding control)
Time frame: 48 hours post procedure
Determine whether pre-reconstruction TXA is non-inferior to post-reconstruction TXA for a composite bleeding event within 48 hours after surgery.
2 secondary outcomes
Compare wound safety outcomes, including dehiscence, infection, and, where applicable, partial or complete flap/graft necrosis. This will be measured via photograph submission at 7-14 days and chart review for phone calls/office in 30 days
Time frame: 30 days
Compare thromboembolic events through 30 days by chart review
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Results publication: PubMed 34087356Kane Z, Picetti R, Wilby A, Standing JF, Grassin-Delyle S, Roberts I, Shakur-Still H. Physiologically based modelling of tranexamic acid pharmacokinetics following intravenous, intramuscular, sub-cutaneous and oral administration in healthy volunteers. Eur J Pharm Sci. 2021 Sep 1;164:105893. doi: 10.1016/j.ejps.2021.105893. Epub 2021 Jun 1.
- Results publication: PubMed 39235116Kumar EA, Morris LM, Michalski-McNeely BM. Tranexamic Acid in Mohs Micrographic Surgery: A Systematic Review. Dermatol Surg. 2025 Jan 1;51(1):17-19. doi: 10.1097/DSS.0000000000004373. Epub 2024 Sep 5.
- Results publication: PubMed 30640775Zilinsky I, Barazani TB, Visentin D, Ahuja K, Martinowitz U, Haik J. Subcutaneous Injection of Tranexamic Acid to Reduce Bleeding During Dermatologic Surgery: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial. Dermatol Surg. 2019 Jun;45(6):759-767. doi: 10.1097/DSS.0000000000001786.
- Results publication: PubMed 36728063Perz AM, Lukowiak TM, Lee MP, Neal D, Aizman L, Miller CJ, Golda N, Albertini JG, Holmes T, Bar A, Leitenberger J, Maher I, Sobanko JF, Chen D, Hollmig T, Aasi S, Sutton A, Higgins HW 2nd, Shin TM, Weinberger C, Mattox A, Wysong A, Etzkorn JR. Postoperative Complications After Interpolated Flap Repair for Mohs Defects of the Nose: A Multicenter Prospective Cohort Study. Dermatol Surg. 2023 Feb 1;49(2):135-139. doi: 10.1097/DSS.0000000000003653. Epub 2022 Dec 22.
- Results publication: PubMed 24080866Alam M, Ibrahim O, Nodzenski M, Strasswimmer JM, Jiang SI, Cohen JL, Albano BJ, Batra P, Behshad R, Benedetto AV, Chan CS, Chilukuri S, Crocker C, Crystal HW, Dhir A, Faulconer VA, Goldberg LH, Goodman C, Greenbaum SS, Hale EK, Hanke CW, Hruza GJ, Jacobson L, Jones J, Kimyai-Asadi A, Kouba D, Lahti J, Macias K, Miller SJ, Monk E, Nguyen TH, Oganesyan G, Pennie M, Pontius K, Posten W, Reichel JL, Rohrer TE, Rooney JA, Tran HT, Poon E, Bolotin D, Dubina M, Pace N, Kim N, Disphanurat W, Kathawalla U, Kakar R, West DP, Veledar E, Yoo S. Adverse events associated with mohs micrographic surgery: multicenter prospective cohort study of 20,821 cases at 23 centers. JAMA Dermatol. 2013 Dec;149(12):1378-85. doi: 10.1001/jamadermatol.2013.6255.
- Results publication: PubMed 37712760Freeman SC, Heath MS, Neill B, Morris C, Lucero OM, Yu W, Bar A, Leitenberger JJ. Tranexamic Acid Prevention of Hemorrhagic Complications Following Interpolated Flap Repair: A Single-Center, Retrospective, Cohort Study. Dermatol Surg. 2023 Dec 1;49(12):1139-1142. doi: 10.1097/DSS.0000000000003931. Epub 2023 Sep 14.
- Results publication: PubMed 32541342Wang W, Lee J, Qin S, Brown MD, Doerr T. Indications and Outcomes of Mohs Micrographic Surgery Using a Multidisciplinary Approach: A Decade of Experience. Dermatol Surg. 2021 Jan 1;47(1):10-15. doi: 10.1097/DSS.0000000000002467.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Subcutaneous TXA injection before reconstruction and Subcutaneous TXA injection after reconstruction in people with Healthy, run by Cooper Norcross Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantity of bleeding events 48 hours after surgery measured via documentation in electronic medical record (phone calls, urgent care/office visits for bleeding control) (time frame: 48 hours post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07807371, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.