What is the mechanism of action of this treatment?

Adenoidectomy is a surgical procedure aimed at removing the adenoids to relieve airway obstruction and chronic infections. The use of devices like LabraGuard, which provide lip protection and aid in retraction, is essential during this surgery. These devices enhance surgical access and visibility, thereby minimizing tissue damage and improving overall surgical outcomes. This is particularly important for ensuring a safer and more effective procedure for adenoidectomy patients.

What side effects are associated with this type of intervention?

Common treatments for adenoidectomy, particularly those involving surgical procedures, can have several side effects. These may include bleeding, infection, pain, and swelling at the surgical site. Additionally, there can be risks associated with anesthesia, such as nausea, vomiting, and allergic reactions. Devices like LabraGuard, which provide lip protection and aid in retraction during surgery, aim to minimize trauma to the lips and surrounding tissues, potentially reducing postoperative discomfort and complications related to soft tissue injury.

What prior FDA approvals exist?

There are no specific FDA-approved drugs for the treatment of adenoidectomy as it is a surgical procedure rather than a condition treated with medication. However, devices similar to the LabraGuard, which provide lip protection and aid in retraction during surgery, are used to enhance surgical outcomes and patient safety. These devices are typically made from medical-grade silicone and are designed to protect soft tissues during various types of surgeries, including those involving the head and neck.

What other types of research exist?

As of now, there are no specific novel alternatives to LabraGuard mentioned in the provided context. However, advancements in medical-grade silicone devices and other protective surgical aids may offer potential alternatives. It is advisable to consult with a healthcare provider for the latest updates on available devices and their suitability for adenoidectomy procedures.

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LabraGuard Device for Oral Surgery

Phase 1

Waitlist Available

Research Sponsored by Nationwide Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Having a surgical procedure done through the mouth where the lips are at risk of injury

Subjects 21 years of age and under

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new device called LabraGuard, which is made of soft silicone and protects children's lips during surgery. Researchers want to see how well it works for kids of different ages.

Who is the study for?

This trial is for children and young adults up to 21 years old who are undergoing oral surgery that could potentially harm their lips. They must be treated by specific departments and give consent, or have a guardian do so. Those with silicone allergies or issues with the device fitting properly cannot participate.

What is being tested?

The LabraGuard, a new soft silicone medical device designed to protect the lips during oral surgeries, is being tested for its effectiveness in different age groups of children.

What are the potential side effects?

Since this trial involves a non-invasive protective device, there may not be direct side effects like those seen with medications; however, potential risks could include allergic reactions to silicone or discomfort from improper fit.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am having surgery through my mouth that might injure my lips.

Select...

I am 21 years old or younger.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Surgical Field Visibility

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Oral Safety DeviceExperimental Treatment1 Intervention

patients on which the device "LabraGuard" is used.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Adenoidectomy is a surgical procedure aimed at removing the adenoids to relieve airway obstruction and chronic infections. The use of devices like LabraGuard, which provide lip protection and aid in retraction, is essential during this surgery. These devices enhance surgical access and visibility, thereby minimizing tissue damage and improving overall surgical outcomes. This is particularly important for ensuring a safer and more effective procedure for adenoidectomy patients.

Tonsillectomy or adenotonsillectomy versus non-surgical treatment for chronic/recurrent acute tonsillitis.