Fat Graft Myringoplasty With and Without Platelet Rich Plasma (PRP) for Treating Smaller Tympanic Membrane Perforations

NCT01958749 | Withdrawn

• 1 other identifier: CDHA/Fat Graft Myringoplasty
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 4

Brief Summary

The current standard treatment for chronic tympanic membrane perforations (TMP) involves having fat grafted from the patient and inserted into the ear, through the perforation, to promote healing using the fat graft myringoplasty (FGM) technique. Platelet rich plasma (PRP) has also been used to promote TMP healing and involves having the patient provide a blood sample, which is processed to produce PRP and applied to the perforation. This prospective, multi-centre study will evaluate whether combining both these techniques can improve the rate of closure in patients with chronic TMP involving \<50% of the membrane. Patients will be randomized to receive either the standard FGM treatment or FGM treatment with the addition of PRP. At 3 months postintervention a blinded observer will rate the degree of TMP closure. Differences in closure rates between the 2 groups will be compared.

Conditions

Tympanic Membrane Perforation

Outcome Measures

Primary Outcomes (1)

• Presence or absence of tympanic membrane perforation

  3 months

Secondary Outcomes (3)

• Degree of perforation closure

  3 months

• Infection rate

  3 months

• Discomfort on using vinegar drops

  2 weeks

Study Arms (2)

Fat graft without Platelet Rich Plasma

NO 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.

Fat graft with Platelet Rich Plasma

EXPERIMENTAL

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

Procedure: Fat graft with Platelet Rich Plasma

Interventions

Fat graft with Platelet Rich Plasma PROCEDURE

Fat graft with Platelet Rich Plasma

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Tympanic membrane perforation measuring \<50% of the area of the membrane
• Perforation present for at least 6 months (based on history or direct observation)
• All edges of perforation are visible

You may not qualify if:

• Active ear infection at the time of the procedure
• cholesteatoma present
• Patients on immunosuppressive therapy (including oral steroids) or chemotherapy
• Patients with previous failed attempt at perforation repair

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (4)

Providence Health St Paul's Hospital

Vancouver, British Columbia, Canada

Location

ENT department, Victoria General Hospital

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Derriford Hospital

Plymouth, Devon, United Kingdom

Location

University Hospital North Staffordshire

Stoke-on-Trent, United Kingdom

Location

MeSH Terms

Conditions

Tympanic Membrane Perforation

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Wounds and Injuries

Study Officials

• Manohar Bance, MD

  Capital Health, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: October 9, 2013
• Study Start: March 1, 2015
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: August 21, 2024

Record last verified: 2013-09

Locations

GB (2); CA (2)