bvand086/sciwritingdataset · Datasets at Hugging Face

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This project was accepted for a poster presentation at the American
Laryngological Association ’s 2022 Spring Meeting at COSM in Dallas,
Texas on April 28 –30, 2022.
There are no ﬁnancial incentives for the investigators, but the PRP
tubes were donated by Eclipse.
Send correspondence to Michael M Johns III, MD, Car
uso Depart-
ment of Otolaryngology –Head and Neck Surgery, Keck School of Medi-
cine, University of Southern California, 1540 Alcazar Street, Suite 204M,
Los Angeles, CA 90033.
E-mail: [email protected]
DOI: 10.1002/lary.30288
Laryngoscope 133: March 2023 van der Woerd et al.: Serial PRP Injections for Vocal Fold Atrophy and Scar
647The Laryngoscope
© 2022 The Authors
The Laryngoscope
published by Wiley Periodicals LLC on
behalf of The American Laryngological,
Rhinological and Otological Society, Inc.
provide a durable effect.8In addition, it carries the risk of
worsening dysphonia due to ﬁller inert mass effect or
super ﬁcially misplaced injection.5
For patients with vocal fold scar, a range of surgical
procedures from augmentation laryngoplasty,9angiolytic
laser procedures,10tissue grafting,11and Gray ’s mini-
thyrotomy12have been described, which also provide
inconsi
stent improvement.13Recent experimental studies
have explored the prospect of restoring normal SLP archi-tecture via stem cell tissue engineering
14and growth fac-
tor injections.15Nevertheless, the paucity of controlled
studies has left a void for a treatment modality that issafe, addresses the fundamental cause, and providesdurable results for patients with vocal fold atrophyor scar.
Platelet-rich plasma (PRP) consists of platelets,
growth factors, cytokines, and cell adhesion moleculesderived from the pa
tient ’s own blood.
16PRP is believed
to activate tissue regeneration by introducing high con-centrations of platelet-derived growth factors and ﬁbrin
into damaged or atrophied tissue.
17Studies in orthope-
dics and cosmetic surgery emphasize the breadth andsafety of the therapeutic applications of PRP.
18–20Previ-
ous work at our institution highlights the technical con-siderations for in-of ﬁce PRP vocal fold injections.
21
Hence, serial PRP vocal fold injections hold promise as
a new treatment modality f
or vocal fold atrophyand scar.
This study aims to evaluate the safety pro ﬁle of
autologous PRP for use as an injectable therapeutic inthe vocal fold
Secondarily, we aim to determine the clini-
cal ef ﬁcacy of serial PRP vocal fold injections regarding
patient-reported outcome measures and longevity ofclinical effects from serial PRP vocal fold injections.
MATERIALS AND METHODS
Study Population
This study was approved by the University of Southern
California Institutional Review Board
Patients were enrolled
as part of an ongoing prospective clinical trial ( clinicaltrials.
gov APP-18-05224) consisting of a series of four unilateral
vocal fold injections with autologous platelet-rich plasma.Vocal fold atrophy and lamina propria defects were diagnosed
on laryngeal videostrobosc o p yb yaf e l l o w s h i p - t r a i n e d
laryngologist
All participants were adults (age 18 years orolder) with a baseline VHI-10 score ≥10
Patients with a his-
tory of allergy or hypersensitiv ity to lidocaine, amide-based
anesthetics, or bovine products were excluded from the trial.
Patients who underwent recent laryngeal surgery or invasive
procedures (e.g., vocal fold injection augmentation) within thelast 3 months were not permitted to enroll., Additionally,
patients with active infection or in ﬂammation in the larynx,
underlying coagulopathy, throm bocytopenia, or platelet dys-
function, autoimmune disease, cancer, liver disease, or respi
-
ratory compromise were excluded
Concomitant laryngealconditions including but not limited to vocal tremor and laryn-
geal dystonia that would otherwise warrant alternative inter-
ventions for optimal treatment were also excluded
Finally,
patients with a life expectancy of less than 6 months were
excluded from this study.Clinical Protocol
The clinical protocol for this clinical trial is outlined in
Figure 1
As part of the initial intake, patients completed the
Voice Handicap Index-10 (VHI-10) and Vocal Fatigue Index
(VFI)
During their initial visit, a complete history and physicalexamination were performed along with voice and laryngeal
videostroboscopy recordings
The ﬁrst PRP vocal fold injection
(Day 0) was performed within 4 weeks of the decision to partici-pate
The patient was monitored for 1 h post procedure for any
potential adverse events
The following day (Day 1), the patient
was re-evaluated in clinic for any side effects or adverse events.
One week following the initial injection the patient was
re-evaluated in clinic and VHI-10 and VFI questionnaires werecollected
Subsequently, the patient returned at monthly inter-
vals for repeat evaluation and re-injection for a total of four uni-
lateral vocal fold injections
The patient ’s subjective experience,
patient-reported outcome measures, and stroboscopic examina-
tion were collected at each visit
Patients continued follow-upvisits at monthly intervals for 3 months following the fourth

This project was accepted for a poster presentation at the American

Laryngological Association ’s 2022 Spring Meeting at COSM in Dallas,

Texas on April 28 –30, 2022.

There are no ﬁnancial incentives for the investigators, but the PRP

tubes were donated by Eclipse.

Send correspondence to Michael M Johns III, MD, Car

uso Depart-

ment of Otolaryngology –Head and Neck Surgery, Keck School of Medi-

cine, University of Southern California, 1540 Alcazar Street, Suite 204M,

Los Angeles, CA 90033.

E-mail: [email protected]

DOI: 10.1002/lary.30288

Laryngoscope 133: March 2023 van der Woerd et al.: Serial PRP Injections for Vocal Fold Atrophy and Scar

647The Laryngoscope

The Laryngoscope

published by Wiley Periodicals LLC on

behalf of The American Laryngological,

Rhinological and Otological Society, Inc.

provide a durable effect.8In addition, it carries the risk of

worsening dysphonia due to ﬁller inert mass effect or

super ﬁcially misplaced injection.5

For patients with vocal fold scar, a range of surgical

procedures from augmentation laryngoplasty,9angiolytic

laser procedures,10tissue grafting,11and Gray ’s mini-

thyrotomy12have been described, which also provide

inconsi

stent improvement.13Recent experimental studies

have explored the prospect of restoring normal SLP archi-tecture via stem cell tissue engineering

14and growth fac-

tor injections.15Nevertheless, the paucity of controlled

studies has left a void for a treatment modality that issafe, addresses the fundamental cause, and providesdurable results for patients with vocal fold atrophyor scar.

Platelet-rich plasma (PRP) consists of platelets,

growth factors, cytokines, and cell adhesion moleculesderived from the pa

tient ’s own blood.

16PRP is believed

to activate tissue regeneration by introducing high con-centrations of platelet-derived growth factors and ﬁbrin

into damaged or atrophied tissue.

17Studies in orthope-

dics and cosmetic surgery emphasize the breadth andsafety of the therapeutic applications of PRP.

18–20Previ-

ous work at our institution highlights the technical con-siderations for in-of ﬁce PRP vocal fold injections.

21

Hence, serial PRP vocal fold injections hold promise as

a new treatment modality f

or vocal fold atrophyand scar.

This study aims to evaluate the safety pro ﬁle of

autologous PRP for use as an injectable therapeutic inthe vocal fold

Secondarily, we aim to determine the clini-

cal ef ﬁcacy of serial PRP vocal fold injections regarding

patient-reported outcome measures and longevity ofclinical effects from serial PRP vocal fold injections.

MATERIALS AND METHODS

Study Population

This study was approved by the University of Southern

California Institutional Review Board

Patients were enrolled

as part of an ongoing prospective clinical trial ( clinicaltrials.

gov APP-18-05224) consisting of a series of four unilateral

vocal fold injections with autologous platelet-rich plasma.Vocal fold atrophy and lamina propria defects were diagnosed

on laryngeal videostrobosc o p yb yaf e l l o w s h i p - t r a i n e d

laryngologist

All participants were adults (age 18 years orolder) with a baseline VHI-10 score ≥10

Patients with a his-

tory of allergy or hypersensitiv ity to lidocaine, amide-based

anesthetics, or bovine products were excluded from the trial.

Patients who underwent recent laryngeal surgery or invasive

procedures (e.g., vocal fold injection augmentation) within thelast 3 months were not permitted to enroll., Additionally,

patients with active infection or in ﬂammation in the larynx,

underlying coagulopathy, throm bocytopenia, or platelet dys-

function, autoimmune disease, cancer, liver disease, or respi

-

ratory compromise were excluded

Concomitant laryngealconditions including but not limited to vocal tremor and laryn-

geal dystonia that would otherwise warrant alternative inter-

ventions for optimal treatment were also excluded

Finally,

patients with a life expectancy of less than 6 months were

excluded from this study.Clinical Protocol

The clinical protocol for this clinical trial is outlined in

Figure 1

As part of the initial intake, patients completed the

Voice Handicap Index-10 (VHI-10) and Vocal Fatigue Index

(VFI)

During their initial visit, a complete history and physicalexamination were performed along with voice and laryngeal

videostroboscopy recordings

The ﬁrst PRP vocal fold injection

(Day 0) was performed within 4 weeks of the decision to partici-pate

The patient was monitored for 1 h post procedure for any

potential adverse events

The following day (Day 1), the patient

was re-evaluated in clinic for any side effects or adverse events.

One week following the initial injection the patient was

re-evaluated in clinic and VHI-10 and VFI questionnaires werecollected

Subsequently, the patient returned at monthly inter-

vals for repeat evaluation and re-injection for a total of four uni-

lateral vocal fold injections

The patient ’s subjective experience,

patient-reported outcome measures, and stroboscopic examina-

tion were collected at each visit

Patients continued follow-upvisits at monthly intervals for 3 months following the fourth