Wound Clinical Trial
Official title:
Does Circumferential Negative Pressure Therapy Impair Distal O2 Saturation? A Randomized Controlled Study
NCT number | NCT03512444 |
Other study ID # | 2181026 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 25, 2018 |
Est. completion date | September 4, 2018 |
Verified date | October 2018 |
Source | King Faisal Specialist Hospital & Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 13 |
Est. completion date | September 4, 2018 |
Est. primary completion date | September 4, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | King Faisal Specialist Hospital & Research Centre | Riyadh |
Lead Sponsor | Collaborator |
---|---|
Ahmed Aljomah |
Saudi Arabia,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area under the curve (AUC) of index finger O2 saturation over 9 hours. | Index finger O2 saturation will be checked every 30 minutes using a pulse oximetry, from zero hour of the study until the end of the 9th hour, then AUC will be calculated. | 9 hours |
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