Clinical trial NCT03512444: Does Circumferential Negative Pressure Therapy Impair Distal O2 Saturation?
Official title: Does Circumferential Negative Pressure Therapy Impair Distal O2 Saturation? A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Negative Pressure Wound Therapy
Wound
Keywords: negative pressure therapy
negative pressure
Wound therapy
NPWT
Vacuum therapy
VAC
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2018-04-30
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups: intervention and control (both are in each arm of the same participant).

Intervention will be applied at one arm (chosen randomly) with using the contralateral arm as a control.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Healthy adult volunteers with O2 saturation ≥95% by pulse oximetry. Potential volunteers will be screened by routine medical history and physical examination and an in-depth upper limb examination

Exclusion Criteria:

* Unhealthy individual
* Chronic conditions
* History of upper limb diseases or defects.
* History of upper limb Surgical intervention.
* History of upper limb implants.
* Pre-study O2 saturation in either indices of less than 95%
* Congenital or Traumatic upper limb defect

Primary outcomes:
measure: Area under the curve (AUC) of index finger O2 saturation over 9 hours.
timeFrame: 9 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Centre
Study officials:
affiliation: King Faisal Specialist Hospital & Research Center
name: Muhammad M Hammami, MD, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: King Faisal Specialist Hospital & Research Center
name: Ahmed S Aljomah, MD
role: PRINCIPAL_INVESTIGATOR
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