What side effects are associated with this type of intervention?

The most common treatments for eardrum perforation, such as Fat Graft Myringoplasty (FGM) and Platelet Rich Plasma (PRP), generally have a favorable safety profile but can have some side effects. FGM may lead to donor site morbidity, infection, and graft failure. PRP, while enhancing healing, can cause localized pain, infection, and inflammation at the injection site. Combining these treatments aims to improve healing rates, but patients should discuss potential risks with their healthcare provider.

What prior FDA approvals exist?

There is limited specific information on prior FDA approvals for treatments of eardrum perforation that directly align with the mechanisms of Fat Graft Myringoplasty (FGM) and Platelet Rich Plasma (PRP). However, the use of autologous materials like fat grafts and PRP in other medical fields suggests a growing interest in regenerative therapies that combine physical scaffolds with biologically active substances to enhance healing. These approaches are being explored in clinical trials, indicating a potential future direction for FDA-approved treatments.

What other types of research exist?

Promising novel alternatives to FGM with PRP for ear drum perforation treatment include the use of bioengineered grafts and stem cell therapy. Bioengineered grafts, such as those incorporating collagen or synthetic polymers, can provide a scaffold for tissue regeneration. Stem cell therapy, particularly using mesenchymal stem cells, has shown potential in promoting tissue repair and regeneration through their differentiation capabilities and secretion of growth factors.

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Fat Graft Myringoplasty + PRP for Ear Drum Perforation

N/A

Waitlist Available

Led By Manohar Bance, MD

Research Sponsored by Nova Scotia Health Authority

Eligibility Criteria Checklist

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

Must have

Perforation present for at least 6 months (based on history or direct observation)

Be older than 18 years old

Must not have

Active ear infection at the time of the procedure

Cholesteatoma present

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if combining fat grafting and a special treatment can better heal small, chronic holes in the eardrum. The fat graft acts as a base for new tissue, and the special treatment helps speed up the healing process. This method is increasingly used for eardrum repair due to its effectiveness in enhancing closure rates and reducing complications.

Who is the study for?

This trial is for individuals with chronic ear drum perforations that are less than half the size of the tympanic membrane, visible from all edges, and present for at least 6 months. People with active ear infections, cholesteatoma, or those on immunosuppressive therapy or chemotherapy cannot participate.

What is being tested?

The study is testing if adding Platelet Rich Plasma (PRP) to the standard fat graft myringoplasty (FGM) improves healing in small ear drum perforations. Participants will be randomly assigned to receive either just FGM or FGM plus PRP and their healing rates compared after 3 months.

What are the potential side effects?

Potential side effects may include discomfort at the site where fat is grafted or blood is drawn for PRP, infection risks associated with any surgical procedure, and possible allergic reactions to materials used.

Eligibility Criteria

Inclusion Criteria

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

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I have had a perforation for at least 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have an ear infection.

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I have a cholesteatoma.

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I am currently on immunosuppressive therapy or chemotherapy.

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I had a failed attempt at fixing a hole in my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

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

Treatment Details

Study Objectives

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

Secondary study objectives

Degree of perforation closure

Infection rate

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Fat graft with Platelet Rich PlasmaExperimental Treatment1 Intervention

Procedure as for as for Fat graft without PRP, but at Step 2 the Gelfoam will instead be soaked in PRP derived from the patient's own whole blood. The generation of PRP is descibed below: - * 10-20 mL of autologous blood collected from an antecubital vein is placed in an adenosine citrate dextrose-acid (ACD-A) collection tube to prevent premature activation * Blood immediately placed in the centrifuge at 1100g for 10 minutes (once) * Supernatant removed and collected into syringe * Injected onto surface of fat graft * Rest added to piece of gelfoam * Place gelfoam + PRP on the TM perforation

Group II: Fat graft without Platelet Rich PlasmaActive Control1 Intervention

Step 1. Under Local Anaesthetic (or General Anaesthetic if the patient is unable to tolerate this), a fat graft is taken from just behind the mastoid process, or more posteriorly just beneath the hairline if necessary. The graft is kept moist in 0.9% saline.The ear canal is injected with local anaesthetic and the edges of the perforation are freshened. Gelfoam is placed into the middle ear and the fat graft placed on top of this until it touches the underside of the TM and slightly bulges through. In an attempt to achieve standardisation of surgical technique between sites, surgeons will be provided with an operative video to watch beforehand. Step 2. The fat graft will simply be covered with a piece of saline-soaked Gelfoam cut to completely cover the perforation and graft.

0 / 5Eligibility 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

Fat Graft Myringoplasty (FGM) and Platelet Rich Plasma (PRP) are common treatments for ear drum perforation. FGM works by providing a physical scaffold that supports tissue regeneration and closure of the perforation. PRP, derived from the patient's own blood, is rich in growth factors that accelerate the healing process by promoting cell proliferation and tissue repair. These mechanisms are crucial for patients as they enhance the natural healing process, potentially leading to faster recovery and improved outcomes in ear drum perforation treatment.