An interventional study of Progressive Tension Sutures in Hematoma and Seroma, sponsored by NYU Langone Health. Terminated at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-30.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment
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.
109 studies on the registry are indexed under Hematoma; 19 are open to participants now.
This study's enrollment of 3 is below the median of 107 across 83 interventional studies indexed under Hematoma.
Browse Hematoma studies →NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Progressive Tension Sutures
Procedure: Progressive Tension Sutures
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)
Total volume of Drain Fluid
Participants will record drain outputs each time they empty drains in the Postoperative Drain Output Record (mL)
Time frame: 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)
Time frame: 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)
Time frame: Visit 4, Day 30
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Thomas.Calahan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
No publications or documents are linked to this record.
Ran from Mar 2021 to primary completion in Jun 2022, 14 months.
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This study is terminated, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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