Wound Clinical Trial
Official title:
Does Circumferential Negative Pressure Therapy Impair Distal O2 Saturation? A Randomized Controlled Study
Abstract:
Background: Circumferential negative pressure wound therapy (CNPWT) is commonly used to
manage wounds and enhance the healing process. A theoretical concern was recently raised that
CNPWT may have a negative effect on perfusion distally. Objectives: We aim to evaluate the
effect of circumferential negative pressure therapy (CNPT) on distal O2 saturation in healthy
volunteers. Design: Randomized controlled non-inferiority study. Methods: Fourteen healthy
adult volunteers with O2 saturation ≥95% (by index finger pulse oximetry) will be invited to
participate in the study. After obtaining a written informed consent, CNPWT foam/dressing
will be applied in a sandwich-like manner on the middle third of each arm and a negative
intermittent pressure of 125 mmHg will be applied to one arm chosen randomly, using the
contralateral arm as control. The pressure will be applied 5 minutes on and 2 minutes off for
9 hours. Individual's participation will be terminated if O2 saturation drops below 92% at
any study time. The outcome measure is index finger O2 saturation and will be checked every
30 minutes using a pulse oximetry. The area under the curve (AUC) of O2 saturation in the 2
arms will be compared using ANCOVA. Sample size was calculated to have 90% power, assuming a
type one error of 5%, non-inferiority margin of 24 (mean AUC difference), SD of 20, and drop
out of 2 participants. Importance: The study is expected to provide conclusive evidence on
the effect of intermittent CNPT on distal O2 saturation. The results would have direct
implications for CNPWT.
The aim of this study is to evaluate the effect of circumferential negative pressure therapy
(CNPT) on distal O2 saturation in healthy volunteers.
Design and Methodology:
Design: This is a randomized controlled non-inferiority study.
Recruitment: Volunteers will be recruited through advertisement in King Faisal Specialist
Hospital & Research Centre and other hospitals in Riyadh.
Pre-study procedures: After obtaining a well documented medical history each volunteer will
undergo a full physical examination as well as an in-depth upper limb examination and
comprehensive evaluation (including a pre-study index finger O2 saturation and upper limbs
circumference measurements), the following data will be also collected: age, sex,
height&weight, body mass index, and vital signs.
Procedures: CNPWT foam and dressing (in accordance to manufacturer's instructions) will be
applied in a sandwich-like manner on the middle third of each arm, and a negative
intermittent pressure of 125 mmHg will be applied to one arm chosen randomly, using the
contralateral arm as control. The pressure will be applied 5 minutes on and 2 minutes off for
9 hours. Individual's participation will be terminated if O2 saturation by pulse oximetry
drops below 92% at any study time.
Statistical analysis: The area under the curve (AUC) of O2 saturation will be compared
between the 2 arms using ANCOVA.
Randomization schedule: a randomization schedule will be generated by an online program
(www.randomization.com). Block randomization will be used.
Sample size: Fourteen adult volunteers will be invited to participate in the study.
The sample size for the study was calculated to have 90% power, assuming a type one error of
5%, non-inferiority margin of 24 (mean AUC difference), SD of 20, and drop out of 2
participants.
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