Trial Outcomes & Findings for Efficacy of Platelet- and Extracellular Vesicle-rich Plasma in Chronic Postsurgical Temporal Bone Inflammations (NCT NCT04281901)
NCT ID: NCT04281901
Last Updated: 2021-08-03
Results Overview
The inflamed tissue in the postoperative temporal bone cavity was observed and photographed otomicroscopically. Then the surface area of the inflamed tissue was determined by using ZEN 3.0 blue edition software(©Carl Zeiss Microscopy GmbH, 2019). Values in square millimetres were transformed to the ratios of the inflamed surface area according to the baseline surface area. The baseline surface area values are therefore 100% for each case or participant.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
Baseline, 1 month, 2 months and 3 months after baseline
Results posted on
2021-08-03
Participant Flow
25 participants with chronic postoperative temporal bone cavity inflammation were recruited at the tertiary otorhinolaryngology referral centre between February- March 2020. In this period the list of patients was created based on examinations and documentation review. 2 participants had bilateral involvement, therefore 27 cases were recruited.
After random allocation 1 patient allocated to the group treated with standard conservative measures refused to participate in the study.
Unit of analysis: case
Participant milestones
| Measure |
PVRP Treated Participants
Participants received platelet- and extracellular vesicle-rich plasma (PVRP)-soaked ear wick in the chronic postoperative temporal bone cavity inflammation at the baseline evaluation (i.e., 1. check-up) and 1 month later (i.e., 2. check-up). Two additional check-ups were performed in a 1-month interval. The aural toilet was applied at each check-up. No other treatment measures were applied
Platelet- and extracellular vesicle-rich plasma: ear wick soaked in platelet- and extracellular vesicle-rich plasma
|
Standardly Treated Participants
Participants were treated with standard conservative measures, including antimicrobials, antiseptics and aural toilette at 1., 2., 3. and 4. check-up.
Standard conservative treatment: standard conservative measures, including antimicrobials, antiseptics and aural toilette for treating a chronically inflamed radical cavity.
|
|---|---|---|
|
Overall Study
STARTED
|
12 12
|
12 14
|
|
Overall Study
2. Check-up
|
11 11
|
11 13
|
|
Overall Study
3. Check-up
|
11 11
|
11 13
|
|
Overall Study
COMPLETED
|
11 11
|
11 13
|
|
Overall Study
NOT COMPLETED
|
1 1
|
1 1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data of time from otosurgery was unknown some cases.
Baseline characteristics by cohort
| Measure |
PVRP Treated Participants
n=11 case
Participants received platelet- and extracellular vesicle-rich plasma (PVRP)-soaked ear wick in the chronic postoperative temporal bone cavity inflammation at the baseline evaluation (i.e., 1. check-up) and 1 month later (i.e., 2. check-up). Two additional check-ups were performed in a 1-month interval. The aural toilet was applied at each check-up. No other treatment measures were applied
Platelet- and extracellular vesicle-rich plasma: ear wick soaked in platelet- and extracellular vesicle-rich plasma
|
Standardly Treated Participants
n=13 case
Participants were treated with standard conservative measures, including antimicrobials, antiseptics and aural toilette at 1., 2., 3. and 4. check-up.
Standard conservative treatment: standard conservative measures, including antimicrobials, antiseptics and aural toilette for treating a chronically inflamed radical cavity.
|
Total
n=24 case
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=11 Participants
|
5 Participants
n=11 Participants
|
13 Participants
n=22 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=11 Participants
|
6 Participants
n=11 Participants
|
9 Participants
n=22 Participants
|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 18 • n=11 Participants
|
52 years
STANDARD_DEVIATION 24 • n=11 Participants
|
50 years
STANDARD_DEVIATION 21 • n=22 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=11 Participants
|
2 Participants
n=11 Participants
|
4 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=11 Participants
|
9 Participants
n=11 Participants
|
18 Participants
n=22 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=11 Participants
|
11 Participants
n=11 Participants
|
22 Participants
n=22 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
|
Region of Enrollment
Slovenia
|
11 participants
n=11 Participants
|
11 participants
n=11 Participants
|
22 participants
n=22 Participants
|
|
Quality of life (i.e., COMQ-12 sum score)
|
32 scores on a scale
STANDARD_DEVIATION 10 • n=11 Participants
|
31 scores on a scale
STANDARD_DEVIATION 10 • n=11 Participants
|
31 scores on a scale
STANDARD_DEVIATION 10 • n=22 Participants
|
|
Presence of bacteria in temporal bone cavity
Bacteria identified
|
10 case
n=11 case
|
12 case
n=13 case
|
22 case
n=24 case
|
|
Presence of bacteria in temporal bone cavity
Bacteria not identified
|
1 case
n=11 case
|
1 case
n=13 case
|
2 case
n=24 case
|
|
Presence of fungi in temporal bone cavity
Fungi identified
|
2 case
n=11 case
|
3 case
n=13 case
|
5 case
n=24 case
|
|
Presence of fungi in temporal bone cavity
Fungi not identified
|
9 case
n=11 case
|
10 case
n=13 case
|
19 case
n=24 case
|
|
Comorbidities
Comorbidities present
|
6 Participants
n=11 Participants
|
6 Participants
n=11 Participants
|
12 Participants
n=22 Participants
|
|
Comorbidities
Comorbidities absent
|
5 Participants
n=11 Participants
|
5 Participants
n=11 Participants
|
10 Participants
n=22 Participants
|
|
Allergies
Allergies present
|
5 Participants
n=11 Participants
|
4 Participants
n=11 Participants
|
9 Participants
n=22 Participants
|
|
Allergies
Allergies absent
|
6 Participants
n=11 Participants
|
7 Participants
n=11 Participants
|
13 Participants
n=22 Participants
|
|
Regular medications
Intake of regular medications
|
3 Participants
n=11 Participants
|
6 Participants
n=11 Participants
|
9 Participants
n=22 Participants
|
|
Regular medications
No intake of regular medications
|
8 Participants
n=11 Participants
|
5 Participants
n=11 Participants
|
13 Participants
n=22 Participants
|
|
Coagulopathy
Presence of coagulopathy
|
2 Participants
n=11 Participants
|
1 Participants
n=11 Participants
|
3 Participants
n=22 Participants
|
|
Coagulopathy
Absence of coagulopathy
|
9 Participants
n=11 Participants
|
10 Participants
n=11 Participants
|
19 Participants
n=22 Participants
|
|
Smoking
Smoking
|
2 Participants
n=11 Participants
|
5 Participants
n=11 Participants
|
7 Participants
n=22 Participants
|
|
Smoking
Not smoking
|
9 Participants
n=11 Participants
|
6 Participants
n=11 Participants
|
15 Participants
n=22 Participants
|
|
Alcohol intake
Regular alcohol intake
|
10 Participants
n=11 Participants
|
7 Participants
n=11 Participants
|
17 Participants
n=22 Participants
|
|
Alcohol intake
No regular alcohol intake
|
1 Participants
n=11 Participants
|
4 Participants
n=11 Participants
|
5 Participants
n=22 Participants
|
|
Time to treatment according to the study protocol
|
7.4 years
n=11 case
|
8.7 years
n=13 case
|
8.1 years
n=24 case
|
|
Time from otosurgery to treatment according to the study protocol
|
12.7 years
n=10 case • Data of time from otosurgery was unknown some cases.
|
14.3 years
n=8 case • Data of time from otosurgery was unknown some cases.
|
13.8 years
n=18 case • Data of time from otosurgery was unknown some cases.
|
|
Underlying otological disease requiring otosurgical treatment
Middle ear cholesteatoma
|
10 case
n=11 case
|
12 case
n=13 case
|
22 case
n=24 case
|
|
Underlying otological disease requiring otosurgical treatment
External auditory canal squamous cell-carcinoma
|
0 case
n=11 case
|
1 case
n=13 case
|
1 case
n=24 case
|
|
Underlying otological disease requiring otosurgical treatment
External auditory canal cholesteatoma
|
1 case
n=11 case
|
0 case
n=13 case
|
1 case
n=24 case
|
PRIMARY outcome
Timeframe: Baseline, 1 month, 2 months and 3 months after baselineThe inflamed tissue in the postoperative temporal bone cavity was observed and photographed otomicroscopically. Then the surface area of the inflamed tissue was determined by using ZEN 3.0 blue edition software(©Carl Zeiss Microscopy GmbH, 2019). Values in square millimetres were transformed to the ratios of the inflamed surface area according to the baseline surface area. The baseline surface area values are therefore 100% for each case or participant.
Outcome measures
| Measure |
PVRP Treated Participants
n=11 case
Participants received platelet- and extracellular vesicle-rich plasma (PVRP)-soaked ear wick in the chronic postoperative temporal bone cavity inflammation at the baseline evaluation (i.e., 1. check-up) and 1 month later (i.e., 2. check-up). Two additional check-ups were performed in a 1-month interval. The aural toilet was applied at each check-up. No other treatment measures were applied
Platelet- and extracellular vesicle-rich plasma: ear wick soaked in platelet- and extracellular vesicle-rich plasma
|
Standardly Treated Participants
n=13 case
Participants were treated with standard conservative measures, including antimicrobials, antiseptics and aural toilette at 1., 2., 3. and 4. check-up.
Standard conservative treatment: standard conservative measures, including antimicrobials, antiseptics and aural toilette for treating a chronically inflamed radical cavity.
|
|---|---|---|
|
Change in Inflammation Surface Area.
1 month
|
43 percentage of the baseline surface
Standard Deviation 30
|
135 percentage of the baseline surface
Standard Deviation 35
|
|
Change in Inflammation Surface Area.
2 months
|
36 percentage of the baseline surface
Standard Deviation 30
|
144 percentage of the baseline surface
Standard Deviation 64
|
|
Change in Inflammation Surface Area.
Baseline evaluation
|
100 percentage of the baseline surface
Standard Deviation 0
|
100 percentage of the baseline surface
Standard Deviation 0
|
|
Change in Inflammation Surface Area.
3 months
|
36 percentage of the baseline surface
Standard Deviation 28
|
150 percentage of the baseline surface
Standard Deviation 97
|
PRIMARY outcome
Timeframe: Baseline, 1 month, 2 months and 3 monthsSum score of Chronic Otitis Media Questionnaire 12 (COMQ-12), patient-reported health-related quality of life measure. Each question is scored from 0 to 5 points, therefore the minimum score value is 0 and the maximum 60. A higher score means worse chronic otitis media-related quality of life. A higher change in COMQ-12 score means a better treatment outcome.
Outcome measures
| Measure |
PVRP Treated Participants
n=11 Participants
Participants received platelet- and extracellular vesicle-rich plasma (PVRP)-soaked ear wick in the chronic postoperative temporal bone cavity inflammation at the baseline evaluation (i.e., 1. check-up) and 1 month later (i.e., 2. check-up). Two additional check-ups were performed in a 1-month interval. The aural toilet was applied at each check-up. No other treatment measures were applied
Platelet- and extracellular vesicle-rich plasma: ear wick soaked in platelet- and extracellular vesicle-rich plasma
|
Standardly Treated Participants
n=11 Participants
Participants were treated with standard conservative measures, including antimicrobials, antiseptics and aural toilette at 1., 2., 3. and 4. check-up.
Standard conservative treatment: standard conservative measures, including antimicrobials, antiseptics and aural toilette for treating a chronically inflamed radical cavity.
|
|---|---|---|
|
Change in Chronic Otitis Media Questionnaire 12 Score
baseline evaluation (i.e., 1. check-up)
|
32 score on a scale
Standard Deviation 10
|
31 score on a scale
Standard Deviation 10
|
|
Change in Chronic Otitis Media Questionnaire 12 Score
2. check-up
|
22 score on a scale
Standard Deviation 12
|
34 score on a scale
Standard Deviation 10
|
|
Change in Chronic Otitis Media Questionnaire 12 Score
3. check-up
|
20 score on a scale
Standard Deviation 11
|
33 score on a scale
Standard Deviation 11
|
|
Change in Chronic Otitis Media Questionnaire 12 Score
4. check-up
|
17 score on a scale
Standard Deviation 10
|
32 score on a scale
Standard Deviation 8
|
SECONDARY outcome
Timeframe: Baseline, 2 monthsThe microbiological analysis included incubation of smear samples to cultivate bacteria, present in postsurgical temporal bone cavity inflammation. Microscopical analyses of colonies were performed to identify the presence of bacteria. Bacteria were absent if no colonies were identified.
Outcome measures
| Measure |
PVRP Treated Participants
n=11 case
Participants received platelet- and extracellular vesicle-rich plasma (PVRP)-soaked ear wick in the chronic postoperative temporal bone cavity inflammation at the baseline evaluation (i.e., 1. check-up) and 1 month later (i.e., 2. check-up). Two additional check-ups were performed in a 1-month interval. The aural toilet was applied at each check-up. No other treatment measures were applied
Platelet- and extracellular vesicle-rich plasma: ear wick soaked in platelet- and extracellular vesicle-rich plasma
|
Standardly Treated Participants
n=13 case
Participants were treated with standard conservative measures, including antimicrobials, antiseptics and aural toilette at 1., 2., 3. and 4. check-up.
Standard conservative treatment: standard conservative measures, including antimicrobials, antiseptics and aural toilette for treating a chronically inflamed radical cavity.
|
|---|---|---|
|
Bacterial Presence
bacteria not identified at the 2. check-up
|
4 case
|
4 case
|
|
Bacterial Presence
bacteria identified at the 2. check-up
|
7 case
|
9 case
|
Adverse Events
PVRP Treated Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standardly Treated Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Domen Vozel, M.D., Saba Battelino, M.D., PhD.
Department of Otorhinolaryngology and Cervicofacial Surgery, University Medical Centre Ljubljana, Ljubljana, Slovenia. Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
Phone: +386 (0)1 522 83 07
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place