Chronic Suppurative Otitis MediaNCT06505252
Comparison of Topical Use of Platelet-rich Plasma Versus Hyaluronic Acid During Endoscopic Fat Graft Myringoplasty: a Randomized Clinical Study
A study testing enoscopic Myringoplasty in people with Chronic Suppurative Otitis Media, run by Assiut University.
Trial summary
This study aimed to compare the effect of adding HA versus PRP to endoscopic FGM in cases of small or medium-sized central TM perforation in the form of: 1. Evaluation of the graft uptake rate. 2. Evaluation and comparing audiological outcomes. 3. Finding out intraoperative and postoperative morbidity. Read more about this study
- Who is it for?
- Ages 14 to 50 years
- Conditions the study is for
- Chronic Suppurative Otitis Media
- What is being tested?
- enoscopic Myringoplasty
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2024to 10 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with central small or median sized dry perforation
- Aged between 14 and 50 years
- In cases of CSOM the perforation must be dry with no otorrhea with healthy middle ear mucosa for at least three month without medications
- Conductive gap on audiometry not more than 40 dB.
Who cannot join
- Discharging CSOM .
- Concurrent URTI .
- CSOM with dry marginal perforation
- Patients who didn't come for follow up.
- Age less than 14 or more than 50.
- Unsafe CSOM with cholesteatoma, apparent retraction pockets, granulations, or extensive myringosclerosis reaching the edges of the perforation. Patients
Show all 13Show fewer
- Patients who are suspected of having Eustachian tube dysfunction.
- Suspected ossicular pathology in safe CSOM if the ABG \> 40dB.
- Patients with history of Previous ear surgery.
- Patients unfit for surgery or having chronic medical illness.
- Narrow external auditory canal.
- Patients who refused to enrolled in our study
- Patients with sensorineural hearing loss or only functioning ear.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Topical Use of Platelet-rich Plasma Versus Hyaluronic Acid During Endoscopic Fat Graft Myringoplasty
This study aimed to compare the effect of adding HA versus PRP to endoscopic FGM in cases of small or medium-sized central TM perforation in the form of:
- Evaluation of the graft uptake rate.
- Evaluation and comparing audiological outcomes.
- Finding out intraoperative and postoperative morbidity.
Read the detailed description
Tympanic membrane (TM) perforations result in recurrent middle ear infection and hearing loss. Both these hazards can be prevented by the reconstructive surgery of the tympanic membrane.
Fat graft myringoplasty (FGM) has been reported as a suitable procedure to close long-standing TM perforations FGM is an efficient, safe and potentially fast method for TM perforation repairing with a success rate varies from 79% to 91%..Many researches was done to use supporting material in myringoplasty Saliba et al used hyaluronic acid fat graft myringoplasty [HAFGM] and results in a higher success rate than using FGM alone. El-Anwar et al proved that Topical autologous platelet-rich plasma(PRP) application during myringolpasty is safe, efficient and enhances healing of TM perforation PRP includes many autologous growth factors that have significant functions like cell proliferation, migration, and angiogenesis. Fibrin and fibronectin are essential proteins in PRP that provide the structural support needed for the cell migration, cell proliferation, and 3-dimensional growth of tissues.
HA has been shown to play a role in cellular signaling, leukocyte growth and migration, Cell adhesion and biological remodeling and is mainly involved in tissue healing with a central role in modulating inflammatory responses also, Its absorption of water causes expansion in volume and formation of a viscoelastic gel which constitutes a favorable scaffold for tissue regeneration and remodeling .
- Conditions
- Chronic Suppurative Otitis Media
- Being tested
- enoscopic Myringoplasty
- Keywords
- CSOM, chronic suppurative otitis media, tympanic membrane perforation, TM perforation, myringoplasty, tympanoplasty, endoscopic tympanoplasty
- Medical subject headings
- Tympanic Membrane Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enoscopic MyringoplastyProcedure or surgery
general anesthesia. A single surgeon will perform all surgeries.
- A small incision in the rim of ear lobule on the same side of the operated ear, a small piece of adipose tissue will be removed according to the experience of the surgeon.
- Using 0 angulation endoscope visualization, the edges of the perforation will be refreshed and deepithelialized with a sharp Rosen's needle
- sponge gel (Gelfoam) will pushed through TM perforation into the middle ear to support the graft and to avoid its medialization
- the previously removed fat graft will be inserted through the perforation adjusted so most of the fat piece lying medial to the perforation and small part laterally in patients group A: 0.5 mL of HA vial will be injected directly over the fat graft and the TM remnant. After 5 minutes small gelfoam pieces soaked in 0.5 mL of HA vial will applied over the fat in patients group B PRPG was inserted into the external auditory canal on the outer face of the TM remnant and fat
| Study group | Role | What they receive |
|---|---|---|
| HA group or group A | Experimental | * All patients underwent operations under general anesthesia. A single surgeon will perform all surgeries.
* A small incision in the rim of ear lobule on the same side of the operated ear, a small piece of adipose tissue will be removed according to the experience of the surgeon.
* The incision will be closed with vicryl 4/0 sutures.
* Using 0 angulation endoscope visualization, the edges of the perforation will be refreshed and deepithelialized with a sharp Rosen's needle or sickle knife.
* sponge gel (Gelfoam) will pushed through TM perforation into the middle ear to support the graft and to avoid its medialization. The previously removed fat graft will be inserted through the perforation adjusted so most of the fat piece lying medial to the perforation and small part laterally. HA was used in liquid form, using a 2 mL vial (® Hyalgan) containing 20 mg of sodium hyaluronate that is synthesized by fermentation. The vial will be prepared for direct injection. Receives: Procedure: enoscopic Myringoplasty |
| PRP group or group B | Experimental | * All patients underwent operations under general anesthesia. A single surgeon will perform all surgeries.
* A small incision in the rim of ear lobule on the same side of the operated ear, a small piece of adipose tissue will be removed according to the experience of the surgeon.
* The incision will be closed with vicryl 4/0 sutures.
* Using 0 angulation endoscope visualization, the edges of the perforation will be refreshed and deepithelialized with a sharp Rosen's needle or sickle knife.
* sponge gel (Gelfoam) will pushed through TM perforation into the middle ear to support the graft and to avoid its medialization The previously removed fat graft will be inserted through the perforation adjusted so most of the fat piece lying medial to the perforation and small part laterally PRPG was inserted into the external auditory canal (EAC) on the outer face of the TM remnant and fat graft. Special attention will be given to obtaining close contact among the PRPG, TM, and fat graft. The Receives: Procedure: enoscopic Myringoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
graft taking
Endoscopic examination of TM: Graft will considered as successfully taken if there is no residual TM perforation after 3 months postoperativly.
Measured: 3 months
Secondary outcomes (2)
Audiotympanogram
effect on hearing by using Audiotympanogram will be done three months post-operative
Measured: 3 months
Otorrhea
presence or absence of otorrhea by history and ear examination
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start30 Aug 2024 (estimated)
- Primary completion9 Jul 2026 (estimated)
- Study completion10 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Suppurative Otitis MediaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly allocated to two groups: By using an online research randomizer (http://www.randomizer.org), patients will be randomly allocated to two groups Group (A): will do endoscopic myringoplasty using fat graft augmented by hylourinic acid Group (B): will do endoscopic myringoplasty using fat graft with PRP
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Gamal Abdel-Hameed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505252
- Sponsor's protocol ID
- Endoscopic fat Myringoplasty
- Status last verified
- Jul 2024
- First submitted
- 3 Jul 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El-Anwar MW, El-Ahl MA, Zidan AA, Yacoup MA. Topical use of autologous platelet rich plasma in myringoplasty. Auris Nasus Larynx. 2015 Oct;42(5):365-8. doi: 10.1016/j.anl.2015.02.016. Epub 2015 Mar 17.
PubMed 25794691Knutsson J, Kahlin A, von Unge M. Clinical and audiological short-term and long-term outcomes of fat graft myringoplasty. Acta Otolaryngol. 2017 Sep;137(9):940-944. doi: 10.1080/00016489.2017.1326063. Epub 2017 May 24.
PubMed 28537107Kim HC, Park KS, Yang HC, Jang CH. Surgical results and factors affecting outcome in patients with fat-graft myringoplasty. Ear Nose Throat J. 2024 Jul;103(7):442-446. doi: 10.1177/01455613211063243. Epub 2021 Dec 9.
PubMed 34881650
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Topical Use of Platelet-rich Plasma Versus Hyaluronic Acid During Endoscopic Fat Graft Myringoplasty
- ClinicalTrials.gov ID
- NCT06505252
- Acronym / sponsor ID
- Endoscopic fat Myringoplasty
- Conditions
- Chronic Suppurative Otitis Media
- Keywords
- CSOM, chronic suppurative otitis media, tympanic membrane perforation, TM perforation, myringoplasty, tympanoplasty, endoscopic tympanoplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Aug 2024 (estimated)
- Primary completion
- 9 Jul 2026 (estimated)
- Study completion
- 10 Oct 2026 (estimated)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to compare the effect of adding HA versus PRP to endoscopic FGM in cases of small or medium-sized central TM perforation in the form of:
- Evaluation of the graft uptake rate.
- Evaluation and comparing audiological outcomes.
- Finding out intraoperative and postoperative morbidity.
Detailed description
Tympanic membrane (TM) perforations result in recurrent middle ear infection and hearing loss. Both these hazards can be prevented by the reconstructive surgery of the tympanic membrane.
Fat graft myringoplasty (FGM) has been reported as a suitable procedure to close long-standing TM perforations FGM is an efficient, safe and potentially fast method for TM perforation repairing with a success rate varies from 79% to 91%..Many researches was done to use supporting material in myringoplasty Saliba et al used hyaluronic acid fat graft myringoplasty [HAFGM] and results in a higher success rate than using FGM alone. El-Anwar et al proved that Topical autologous platelet-rich plasma(PRP) application during myringolpasty is safe, efficient and enhances healing of TM perforation PRP includes many autologous growth factors that have significant functions like cell proliferation, migration, and angiogenesis. Fibrin and fibronectin are essential proteins in PRP that provide the structural support needed for the cell migration, cell proliferation, and 3-dimensional growth of tissues.
HA has been shown to play a role in cellular signaling, leukocyte growth and migration, Cell adhesion and biological remodeling and is mainly involved in tissue healing with a central role in modulating inflammatory responses also, Its absorption of water causes expansion in volume and formation of a viscoelastic gel which constitutes a favorable scaffold for tissue regeneration and remodeling .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Patients will be randomly allocated to two groups: By using an online research randomizer (http://www.randomizer.org), patients will be randomly allocated to two groups Group (A): will do endoscopic myringoplasty using fat graft augmented by hylourinic acid Group (B): will do endoscopic myringoplasty using fat graft with PRP
| Arm | Type | Receives |
|---|---|---|
| HA group or group A | Experimental | Procedure: enoscopic Myringoplasty* All patients underwent operations under general anesthesia. A single surgeon will perform all surgeries. * A small incision in the rim of ear lobule on the same side of the operated ear, a small piece of adipose tissue will be removed according to the experience of the surgeon. * The incision will be closed with vicryl 4/0 sutures. * Using 0 angulation endoscope visualization, the edges of the perforation will be refreshed and deepithelialized with a sharp Rosen's needle or sickle knife. * sponge gel (Gelfoam) will pushed through TM perforation into the middle ear to support the graft and to avoid its medialization. The previously removed fat graft will be inserted through the perforation adjusted so most of the fat piece lying medial to the perforation and small part laterally. HA was used in liquid form, using a 2 mL vial (® Hyalgan) containing 20 mg of sodium hyaluronate that is synthesized by fermentation. The vial will be prepared for direct injection. |
| PRP group or group B | Experimental | Procedure: enoscopic Myringoplasty* All patients underwent operations under general anesthesia. A single surgeon will perform all surgeries. * A small incision in the rim of ear lobule on the same side of the operated ear, a small piece of adipose tissue will be removed according to the experience of the surgeon. * The incision will be closed with vicryl 4/0 sutures. * Using 0 angulation endoscope visualization, the edges of the perforation will be refreshed and deepithelialized with a sharp Rosen's needle or sickle knife. * sponge gel (Gelfoam) will pushed through TM perforation into the middle ear to support the graft and to avoid its medialization The previously removed fat graft will be inserted through the perforation adjusted so most of the fat piece lying medial to the perforation and small part laterally PRPG was inserted into the external auditory canal (EAC) on the outer face of the TM remnant and fat graft. Special attention will be given to obtaining close contact among the PRPG, TM, and fat graft. The |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients with central small or median sized dry perforation
- Aged between 14 and 50 years
- In cases of CSOM the perforation must be dry with no otorrhea with healthy middle ear mucosa for at least three month without medications
- Conductive gap on audiometry not more than 40 dB.
Key exclusion criteria (13 listed)
- Discharging CSOM .
- Concurrent URTI .
- CSOM with dry marginal perforation
- Patients who didn't come for follow up.
- Age less than 14 or more than 50.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enoscopic Myringoplastygeneral anesthesia. A single surgeon will perform all surgeries. * A small incision in the rim of ear lobule on the same side of the operated ear, a small piece of adipose tissue will be removed according to the experience of the surgeon. * Using 0 angulation endoscope visualization, the edges of the perforation will be refreshed and deepithelialized with a sharp Rosen's needle * sponge gel (Gelfoam) will pushed through TM perforation into the middle ear to support the graft and to avoid its medialization * the previously removed fat graft will be inserted through the perforation adjusted so most of the fat piece lying medial to the perforation and small part laterally in patients group A: 0.5 mL of HA vial will be injected directly over the fat graft and the TM remnant. After 5 minutes small gelfoam pieces soaked in 0.5 mL of HA vial will applied over the fat in patients group B PRPG was inserted into the external auditory canal on the outer face of the TM remnant and fat | Procedure or surgery | HA group or group A, PRP group or group B |
Primary outcome
graft taking
Time frame: 3 months
Endoscopic examination of TM: Graft will considered as successfully taken if there is no residual TM perforation after 3 months postoperativly.
2 secondary outcomes
Audiotympanogram
Time frame: 3 months
Otorrhea
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Background: PubMed 25794691El-Anwar MW, El-Ahl MA, Zidan AA, Yacoup MA. Topical use of autologous platelet rich plasma in myringoplasty. Auris Nasus Larynx. 2015 Oct;42(5):365-8. doi: 10.1016/j.anl.2015.02.016. Epub 2015 Mar 17.
- Background: PubMed 28537107Knutsson J, Kahlin A, von Unge M. Clinical and audiological short-term and long-term outcomes of fat graft myringoplasty. Acta Otolaryngol. 2017 Sep;137(9):940-944. doi: 10.1080/00016489.2017.1326063. Epub 2017 May 24.
- Background: PubMed 34881650Kim HC, Park KS, Yang HC, Jang CH. Surgical results and factors affecting outcome in patients with fat-graft myringoplasty. Ear Nose Throat J. 2024 Jul;103(7):442-446. doi: 10.1177/01455613211063243. Epub 2021 Dec 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing enoscopic Myringoplasty in people with Chronic Suppurative Otitis Media, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Gamal Ahmed Gamal Abdel-Hameed, Assistant lecture (00201063211000, jamal1991989@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
graft taking (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06505252, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.