Progressive Tension Sutures for Hematoma

Phase-Based Estimates
1
Effectiveness
1
Safety
NYU Langone Health, New York, NY
Hematoma+1 More
Progressive Tension Sutures - Procedure
Eligibility
18+
Male
Eligible conditions
Hematoma

Study Summary

This study is evaluating whether progressive tension sutures between pectoral fascia and the mastectomy flap may help reduce complications following gender affirming mastectomy.

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Eligible Conditions

  • Hematoma
  • Seroma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Progressive Tension Sutures will improve 1 primary outcome in patients with Hematoma. Measurement will happen over the course of Visit 4, Day 30.

Visit 4, Day 30
Total volume of Drain Fluid

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Left-Sided Progressive Tension Sutures
Right-Sided Progressive Tension Sutures

This trial requires 50 total participants across 2 different treatment groups

This trial involves 2 different treatments. Progressive Tension Sutures is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Right-Sided Progressive Tension Sutures
Procedure
Left-Sided Progressive Tension Sutures
Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Progressive Tension Sutures
2012
Completed Phase 2
~50

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: visit 4, day 30
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly visit 4, day 30 for reporting.

Closest Location

NYU Langone Health - New York, NY

Eligibility Criteria

This trial is for male patients aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes hematoma?

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It is important that in the past 15 years, clinicians have recognized that there was much more to the cause of hematoma than just a delay in diagnosis. Although there are a variety of causes for a hematoma, all of them can lead to hematoma if left untreated. The main causes are arterial tear, traumatic fracture, and intimal tear, which were most likely to be neglected in the past. It is important for clinicians to be aware of these causes and educate patients about how they can prevent or reduce hematoma formation and its consequences.

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How many people get hematoma a year in the United States?

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An estimated 10 million adults receive treatment for an epidural hematoma annually in the United States. Most patients experience no complications but 25% to 52% of patients will require hospitalization and may require surgical intervention. Epidural hematomas were not associated with chronic neurological deficits.

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What is hematoma?

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A hematoma, an extramedullary mass of blood, can involve the central nervous system. Hematomas may be a manifestation of vascular malformations, arteriovenous malformations, or arteriovenous fistulae. Hemorrhage or hematoma in adults is uncommon, but its rarity may be exaggerated because of the tendency of hematomas to become asymptomatic when they are small relative to other symptoms. Unlike typical hematomas, extravascular hematomas of the central nervous system may result in signs and symptoms suggestive of brain infarction.

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Can hematoma be cured?

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Data from a recent study has found no instances of hematoma cure when using the usual modalities. However, due to the severity of the condition in cases which were not adequately treated, we would strongly support consideration of further treatment, particularly in the case of large hematoma.

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What are the signs of hematoma?

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This is one of the earliest signs of hematoma, and it can be seen before pain or the development of skin changes. The symptoms should be prompt; if they are not present after one hour, a hematoma will probably have developed even if nothing was done to cause it.

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What are common treatments for hematoma?

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There is no clear evidence of any benefits of conservative management of hematoma compared with surgical drainage. The most commonly recommended treatment is embolization if the source can be determined (hematoma is embolized in the vast majority of cases).

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Is progressive tension sutures typically used in combination with any other treatments?

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In a recent study, findings show no significant difference in the use of the three different tension sutures. Although the use of the three sutures increased the pain at the initial use for a short period, this did not make a difference for the final level of pain relief. Considering the benefits of the tension sutures for relieving the pain in the initial usage and decreasing postoperative morbidity, these results indicate that using tension sutures as an additional treatment can be recommended in patients with tension suture(s) following surgery.

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How serious can hematoma be?

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Patients usually recover completely, with almost no disability and no long- term complications. However, there are exceptions, and some patients still have long-term disability as a result of severe neurological deficits, post-hematoma hydrocephalus, and hematoma expansion into the brain parenchyma. In addition, a hematoma that crosses the corpus callosum may spread and cause a progressive deterioration of consciousness. Patients with symptomatic hematoma or hematoma associated with post-traumatic complications should be brought to specialist centers, especially neurological surgeons, and urgent CT imaging is recommended.

Unverified Answer

Does progressive tension sutures improve quality of life for those with hematoma?

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Tension suture placement improves cosmesis in the setting of a hematoma and enhances healing. Future studies should address the impact of suture tension on pain relief, length of hospitalization, and quality of life.

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Does hematoma run in families?

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We confirmed the previously reported association of SLE and a HBD with hematoma. Results from a recent clinical trial also shows the necessity of the use of family history in order to be properly managed: even a single family member with SLE poses the risk of serious hematomas.

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What are the latest developments in progressive tension sutures for therapeutic use?

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Tension sutures are the most recent, effective, and safe method of treatment for hemorrhage caused by pelvic fractures. Tension sutures are highly effective and are especially useful in patients requiring surgical intervention immediately following a pelvic fracture. Tension sutures may be used when laparotomy is contraindicated, such as in patients with active bleeding from the pelvis, unstable pelvic structures, or advanced pelvic organ prolapse.

Unverified Answer

What is the latest research for hematoma?

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Although hematoma incidence rates have declined over the last several decades, hematoma incidence rates continue to be high in industrialized nations and continue to warrant further investigation.

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