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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study Summary

This trial will compare two methods of treating chronic TMP to see if combining them leads to improved healing rates.

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.Check my eligibility

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.See study design

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

Select...

I have had a perforation for at least 6 months.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Presence or absence of tympanic membrane perforation

Secondary outcome measures

Degree of perforation closure

Discomfort on using vinegar drops

Infection rate

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 / 1Eligibility criteria met