bvand086/sciwritingdataset · Datasets at Hugging Face

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injection (Fig.
2).
Drug/Device Information and Administration
The leukocyte poor platelet-rich plasma preparation was
achieved via the Eclipse PRP®system manufactured by Eclipse
Med
The Eclipse PRP®system is an FDA-cleared 510(k) Class II
medical device (BK110035)
Activation of PRP in our study is
accomplished without exogenous substances by relying on shearforce from injection and exposure to native collagen at the injec-
tion site.
18Patients underwent venipuncture to collect 11 ml of
blood
The collected blood was placed in the Eclipse PRP®system
centrifuge per product protocol.
Study Agent Administration
Unilateral injection of 1.0 –2.0 cc of PRP into the membra-
nous vocal fold near the area of the scar on the pre-determined
side was performed using a 23-gauge needle via previouslydescribed percutaneous methods for vocal fold injection (thy-
rohyoid, transoral approaches).
8Trans-cervical injections were
carried out through the thyro-hyoid approach with no signi ﬁcant
leakage of PRP noted du
ring these injections
Injections were
performed throughout this study taking care to place the needle
super ﬁcially into the vocal fold
The PRP then tracks throughout
the entire surface of the super ﬁcial vocal fold and bulges the epi-
thelium
Once material begins to extrude, commonly between1 and 1.5 cc, the injection is concluded
All injections were per-
formed in an outpatient clinic setting under local and topical
anesthesia apart from one patient who requested injection 2 be
performed in the operating room due to intolerance of awake in-
ofﬁce vocal fold injection
Due to this patient ’s preference,
accommodations were made to perform injections 3 and 4 in the
operating room as well
The contralateral vocal fold did not
undergo injection and served as an internal control
During
interim periods between scheduled visits, subjects were
instructed to call with any potential adverse event that mayrequire in-person evaluation at the clinic or in an acute care
setting for appropriate clinical care.
Evaluation Criteria and Endpoint De ﬁnitions
Study completion was achieved after patients received four
unilateral PRP injections and completed all follow-up post-
injection clinic visits
The main objective of this study is to de ﬁne
the safety pro ﬁle of PRP for use with serial vocal fold injections to
treat vocal fold atrophy and scar
As such, the focus will be on any
Laryngoscope 133: March 2023 van der Woerd et al.: Serial PRP Injections for Vocal Fold Atrophy and Scar
648
15314995, 2023, 3, Downloaded from https://onlinelibrary.wiley.com/doi/10.1002/lary.30288 by Mcmaster University Library Collections L307, Wiley Online Library on [07/09/2023]
See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
treatment-related adverse events that are reported during the
study
Previously cited adverse events in vocal fold injectioninclude local tissue reactivity, hemorrhage, hematoma, granulomaformation, and postprocedural airway compromise.
22Secondary
endpoints included patient-reported outcome measures (VHI-10,
VFI) from designated follow-up time points which are compared tobaseline values prior to the ﬁrst injection
Follow-up duration
refers to the number of months since a patient ’sﬁrst injection and
continues to accumulate after all four injections have been admin-istered
For patients with vocal fold scars, we did not include spe-
ciﬁc etiology in our demographic information as many patients
had longstanding scars of unknown etiology.
Statistical Analysis
Sample size calculations were performed based on data
from prior studies for VHI-10 outcomes after vocal fold augmen-
tation for vocal fold atrophy.23These calculations were based on
a planned comparison of VHI-10 scores before and after serial
PRP injections via paired t-test statistics
All comparisons were
made between baseline scores and individual post-injection time-point
The primary outcome of safety was focused on the inci-
dence of serious adverse events related to the study material
under investigation
We expected the risk of a serious adverse
event to be exceedingly low and did not base our sample size cal-
culation on that
The study cohort will be analyzed using descrip-tive statistics of the primary outcome
The incidence of both
minor and major adverse events will be measured as a percent of
total participants experiencing said adverse event
Comparisonof patient-reported outcome measures from post-intervention
time points to pre-intervention baseline were evaluated using
parametric statistics ( t-test, paired two samples for means,
two-tail).
RESULTS
Twelve patients with vocal fold scar or atrophy under-
went unilateral vocal fold injection with autologous PRPprepared according to Eclipse PRP
®system protocol
A total
of 43 injections were performed using a peroral or percuta-neous approach
An overview of study participant demo-graphics and pathology is outlined in Table
I
An average of

injection (Fig.

2).

Drug/Device Information and Administration

The leukocyte poor platelet-rich plasma preparation was

achieved via the Eclipse PRP®system manufactured by Eclipse

Med

The Eclipse PRP®system is an FDA-cleared 510(k) Class II

medical device (BK110035)

Activation of PRP in our study is

accomplished without exogenous substances by relying on shearforce from injection and exposure to native collagen at the injec-

tion site.

18Patients underwent venipuncture to collect 11 ml of

blood

The collected blood was placed in the Eclipse PRP®system

centrifuge per product protocol.

Study Agent Administration

Unilateral injection of 1.0 –2.0 cc of PRP into the membra-

nous vocal fold near the area of the scar on the pre-determined

side was performed using a 23-gauge needle via previouslydescribed percutaneous methods for vocal fold injection (thy-

rohyoid, transoral approaches).

8Trans-cervical injections were

carried out through the thyro-hyoid approach with no signi ﬁcant

leakage of PRP noted du

ring these injections

Injections were

performed throughout this study taking care to place the needle

super ﬁcially into the vocal fold

The PRP then tracks throughout

the entire surface of the super ﬁcial vocal fold and bulges the epi-

thelium

Once material begins to extrude, commonly between1 and 1.5 cc, the injection is concluded

All injections were per-

formed in an outpatient clinic setting under local and topical

anesthesia apart from one patient who requested injection 2 be

performed in the operating room due to intolerance of awake in-

ofﬁce vocal fold injection

Due to this patient ’s preference,

accommodations were made to perform injections 3 and 4 in the

operating room as well

The contralateral vocal fold did not

undergo injection and served as an internal control

During

interim periods between scheduled visits, subjects were

instructed to call with any potential adverse event that mayrequire in-person evaluation at the clinic or in an acute care

setting for appropriate clinical care.

Evaluation Criteria and Endpoint De ﬁnitions

Study completion was achieved after patients received four

unilateral PRP injections and completed all follow-up post-

injection clinic visits

The main objective of this study is to de ﬁne

the safety pro ﬁle of PRP for use with serial vocal fold injections to

treat vocal fold atrophy and scar

As such, the focus will be on any

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

648

15314995, 2023, 3, Downloaded from https://onlinelibrary.wiley.com/doi/10.1002/lary.30288 by Mcmaster University Library Collections L307, Wiley Online Library on [07/09/2023]

See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License

treatment-related adverse events that are reported during the

study

Previously cited adverse events in vocal fold injectioninclude local tissue reactivity, hemorrhage, hematoma, granulomaformation, and postprocedural airway compromise.

22Secondary

endpoints included patient-reported outcome measures (VHI-10,

VFI) from designated follow-up time points which are compared tobaseline values prior to the ﬁrst injection

Follow-up duration

refers to the number of months since a patient ’sﬁrst injection and

continues to accumulate after all four injections have been admin-istered

For patients with vocal fold scars, we did not include spe-

ciﬁc etiology in our demographic information as many patients

had longstanding scars of unknown etiology.

Statistical Analysis

Sample size calculations were performed based on data

from prior studies for VHI-10 outcomes after vocal fold augmen-

tation for vocal fold atrophy.23These calculations were based on

a planned comparison of VHI-10 scores before and after serial

PRP injections via paired t-test statistics

All comparisons were

made between baseline scores and individual post-injection time-point

The primary outcome of safety was focused on the inci-

dence of serious adverse events related to the study material

under investigation

We expected the risk of a serious adverse

event to be exceedingly low and did not base our sample size cal-

culation on that

The study cohort will be analyzed using descrip-tive statistics of the primary outcome

The incidence of both

minor and major adverse events will be measured as a percent of

total participants experiencing said adverse event

Comparisonof patient-reported outcome measures from post-intervention

time points to pre-intervention baseline were evaluated using

parametric statistics ( t-test, paired two samples for means,

two-tail).

RESULTS

Twelve patients with vocal fold scar or atrophy under-

went unilateral vocal fold injection with autologous PRPprepared according to Eclipse PRP

®system protocol

A total

of 43 injections were performed using a peroral or percuta-neous approach

An overview of study participant demo-graphics and pathology is outlined in Table

I

An average of