HematomaNCT04818580
Progressive Tension Sutures in Gender Affirming Mastectomy
A study testing Progressive Tension Sutures in people with Hematoma and Seroma, run by NYU Langone Health at 1 site in United States.
Trial summary
50 patients seeking gender affirming mastectomy will be treated with different closure techniques in each side of their chest - one side will receive progressive tension sutures between pectoral fascia and the mastectomy flap, and the other side will not. Both sides will have drains in the mastectomy site. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- What is being tested?
- Progressive Tension Sutures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2021to 21 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being consulted for gender affirming mastectomy with the senior author (AH).
- >18 years of age at the time of enrollment.
- Transgender or gender nonbinary gender identity.
- All co-morbidities and all indications.
Who cannot join
- Age less than 18 years.
- BMI < 23.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Cohort Study Comparing the Effect of Progressive Tension Sutures and Drains to Drains Alone on Rates of Hematoma and Seroma in Gender Affirming Mastectomy for Transgender Men
50 patients seeking gender affirming mastectomy will be treated with different closure techniques in each side of their chest - one side will receive progressive tension sutures between pectoral fascia and the mastectomy flap, and the other side will not. Both sides will have drains in the mastectomy site. Rates of hematoma, seroma, and other complications will be compared between each chest side via standard statistical techniques for hypothesis testing.
- Being tested
- Progressive Tension Sutures
- Keywords
- Mastectomy
- Medical subject headings
- Hematoma, Seroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Tension SuturesProcedure or surgery
In each patient, one side of the chest will receive progressive tension sutures inside the mastectomy pocket, from pectoral fascia to underside of mastectomy flap. 2-0 Vicryl about 15-20 sutures per chest. Both sides will receive bilateral drains (standard of care)
| Study group | Role | What they receive |
|---|---|---|
| Right-Sided Progressive Tension Sutures | Experimental | Not described Receives: Procedure: Progressive Tension Sutures |
| Left-Sided Progressive Tension Sutures | Active comparator | Not described Receives: Procedure: Progressive Tension Sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total volume of Drain Fluid
Participants will record drain outputs each time they empty drains in the Postoperative Drain Output Record (mL)
Measured: Visit 2, Day 7
Total volume of Drain Fluid
Participants will record drain outputs each time they empty drains in the Postoperative Drain Output Record (mL)
Measured: Visit 3, Day 14
Total volume of Drain Fluid
Participants will record drain outputs each time they empty drains in the Postoperative Drain Output Record (mL)
Measured: Visit 4, Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start25 Mar 2021
- Primary completion21 Jun 2022
- Study completion21 Jun 2022
Why it stopped: Departure of key personnel, difficulties with recruiting.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HematomaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexes Hazen, MD FACS, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818580
- Sponsor's protocol ID
- 20-01803
- Status last verified
- Jan 2023
- First submitted
- 25 Mar 2021
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study Comparing the Effect of Progressive Tension Sutures and Drains to Drains Alone on Rates of Hematoma and Seroma in Gender Affirming Mastectomy for Transgender Men
- ClinicalTrials.gov ID
- NCT04818580
- Acronym / sponsor ID
- 20-01803
- Keywords
- Mastectomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Departure of key personnel, difficulties with recruiting.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 21 Jun 2022 (actual)
- First posted
- 26 Mar 2021 (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.
50 patients seeking gender affirming mastectomy will be treated with different closure techniques in each side of their chest - one side will receive progressive tension sutures between pectoral fascia and the mastectomy flap, and the other side will not. Both sides will have drains in the mastectomy site. Rates of hematoma, seroma, and other complications will be compared between each chest side via standard statistical techniques for hypothesis testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right-Sided Progressive Tension Sutures | Experimental | Procedure: Progressive Tension Sutures |
| Left-Sided Progressive Tension Sutures | Active comparator | Procedure: Progressive Tension Sutures |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being consulted for gender affirming mastectomy with the senior author (AH).
- >18 years of age at the time of enrollment.
- Transgender or gender nonbinary gender identity.
- All co-morbidities and all indications.
Key exclusion criteria (2 listed)
- Age less than 18 years.
- BMI < 23.
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 |
|---|---|---|
| Progressive Tension SuturesIn each patient, one side of the chest will receive progressive tension sutures inside the mastectomy pocket, from pectoral fascia to underside of mastectomy flap. 2-0 Vicryl about 15-20 sutures per chest. Both sides will receive bilateral drains (standard of care) | Procedure or surgery | Left-Sided Progressive Tension Sutures, Right-Sided Progressive Tension Sutures |
Primary outcome
Total volume of Drain Fluid
Time frame: Visit 2, Day 7
Participants will record drain outputs each time they empty drains in the Postoperative Drain Output Record (mL)
Total volume of Drain Fluid
Time frame: Visit 3, Day 14
Participants will record drain outputs each time they empty drains in the Postoperative Drain Output Record (mL)
Total volume of Drain Fluid
Time frame: Visit 4, Day 30
Participants will record drain outputs each time they empty drains in the Postoperative Drain Output Record (mL)
Results and safety
The study was stopped early (reason given: Departure of key personnel, difficulties with recruiting.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
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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. This study is not recruiting at the moment.
Alexes Hazen, MD FACS principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Tension Sutures in people with Hematoma and Seroma, run by NYU Langone Health at 1 site in United States.
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 2 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: stopped early, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: Departure of key personnel, difficulties with recruiting.). Results are not available in the source record.
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?
Total volume of Drain Fluid (time frame: Visit 2, Day 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2023.