Sensory neurotization for Sensitization

Phase-Based Estimates
1
Effectiveness
1
Safety
Health Science Centre, Winnipeg, Canada
Sensory neurotization - Procedure
Eligibility
18+
Female
Eligible conditions
Sensitization

Study Summary

This study is evaluating whether a flap that has sensation is better than a flap that does not have sensation.

See full description

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Sensory neurotization will improve 1 primary outcome in patients with Sensitization. Measurement will happen over the course of 12 months post-operatively.

12 months post-operatively
Sensory recovery to neurotized DIEP flap

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
DIEP reconstruction, neurotization

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. Sensory Neurotization 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.

DIEP reconstruction, neurotization
Procedure
DIEP reconstruction With sensory neurotization
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months post-operatively
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 months post-operatively for reporting.

Closest Location

Health Science Centre - Winnipeg, Canada

Eligibility Criteria

This trial is for female 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:
The text states that the study will include female subjects who are older than 18. show original
After a bilateral non-nipple sparing mastectomy, the patient is scheduled for bilateral breast reconstruction surgery. show original
DIEP flap reconstruction is a breast reconstruction surgery that uses a flap of skin and fat from your abdomen. show original
With a large, flat piece of skin. show original

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 are the signs of sensitization?

Add answer

The skin may be pale or slightly red and it may be very difficult to see the blood vessel when the body is cold. Cold urticaria may occur and may also affect areas other than the skin. In severe cases there may be a rash-like scaling of the bottom of the feet, hands or face. When there are persistent symptoms it may be prudent to send them to a physician for confirmation and treatment. It is vital that symptoms do not persist for longer than a few weeks, as it will not be helpful from a medical standpoint. Symptoms of the following disorders should not be confused with the symptoms of a rash: allergy, asthma, or a contact dermatitis.

Unverified Answer

What are common treatments for sensitization?

Add answer

Sensitization is a common and frequently unrecognized condition affecting allergic diseases (excessive reactivity to allergens) in which skin is the affected organ. Immunotherapy may or may not be effective in the treatment of various types of sensitizations. Allergy testing is a routine examination of patients.\n

Unverified Answer

Can sensitization be cured?

Add answer

We report a simple approach to permanent sensitization of CTL cells to tumor antigens by ex vivo priming with dendritic cells. Further, it is possible to show that the sensitization is indeed permanent, which is an important step towards overcoming the immune tolerance that the tumor presents.

Unverified Answer

What causes sensitization?

Add answer

As allergic rhinoconjunctivitis is an allergic disease, allergic rhinitis is a risk factor. The pathogenesis is a dynamic process leading to sensitization. There is the possibility of reversing the process, which requires specific anti-allergic therapy.

Unverified Answer

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

Add answer

More people get sensitized in the US than in other western countries. There is almost a linear trend in the number of new sensitizations per 1,000 sensitized patients per year. As the USA becomes more industrialized, the number of sensitized patients will continue to increase. This could be linked to the increase in the prevalence of atopy.

Unverified Answer

What is sensitization?

Add answer

The phenomenon of sensitization in humans is very similar to that reported in other animal species. Sensitization or imprinting has been reported in a wide range of animal species and for most of them it occurs before birth. Sensitization in rats is mediated by maternal hormones and occurs prior to the development of the adaptive immune system.\n\n- SSS"

"Anaphe ocellea\n\nAnaphe ocellea is a species of moth of the family Noctuidae. It is found in France, Spain, Portugal, Italy, Albania, Greece, the Republic of Macedonia, Bulgaria, Romania, North Macedonia, Ukraine, Russia and Japan.

Unverified Answer

Is sensory neurotization safe for people?

Add answer

The sensory neurotization method is simple to integrate into the practice of the DRE team, and we believe it may have a substantial impact on the clinical management of sensitizers.

Unverified Answer

What is sensory neurotization?

Add answer

Sensory information is one of the major determinants of anesthetic sensitivity and autonomic instability. These factors make patients more susceptible to intraoperative brain damage during or after surgery, or anesthetic complications. Sensory neurotization occurs following an inflammatory reaction, which is thought to be a major contributor to anesthesia and surgery-related neurotoxicity. Sensory neurotization could therefore be a key determinant of anesthesia and surgery-related damage in patients with severe inflammation.

Unverified Answer

What are the common side effects of sensory neurotization?

Add answer

Specific sensory sensations were usually present in the most part of the patients, but were not always a cause of clinical symptoms. The presence of certain sensations does not necessarily mean that the patient has not experienced one before. To be truly defined as a neurosensory patient, the patient must complain of sensory symptoms, e.g., pain/hypoesthesia, tactile sensation, itching and tingling. The most common symptoms are itching with skin contact or light touch to palms of hands and feet, numbness or paresthesia, burning pain with cold temperature, and tactile sensation in fingertips. The diagnosis is a result of thorough clinical findings and a proper use of objective testing.

Unverified Answer

Is sensory neurotization typically used in combination with any other treatments?

Add answer

The most frequent use of sensitizations in combination with other treatments was used (45%, i.e., combined drug use of a neurotropic and of a drug or toxin) followed by treatments used alone (39%, i.e., a single neurotropic and of a drug or toxin or treatment based only on a neurotropic). To diminish neurotropic use, we suggest to modify the neurotropic treatment or choose a neurotropic alternative treatment.

Unverified Answer

Who should consider clinical trials for sensitization?

Add answer

The main problem with designing clinical trials for sensitization is finding patients to take part in the trial. Findings from a recent study and conclusions of the trial will be dependent on the participants' willingness to participate and to the type of trial. The aim of this study was to identify those at risk of developing SJS, and thereby allow identification of patients likely to be suitable for such clinical trials.

Unverified Answer

Has sensory neurotization proven to be more effective than a placebo?

Add answer

The treatment efficacy of sensory neurotization may be related to the increase in activity in the primary sensory cortex and thalamus, as well as to the decrease of activity in somatosensory associative regions in sensory processing. Sensory neurotization might be an effective therapy for the treatment of post-traumatic headaches in patients who suffer from sensory and somatosensory alterations.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Sensitization by sharing your contact details with the study coordinator.