Does Circumferential Negative Pressure Therapy Impair Distal O2 Saturation?

NCT03512444 | Completed FDA Device

• 1 other identifier: 2181026
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Negative Pressure Wound Therapy; Wound

Keywords

negative pressure therapy; negative pressure; Wound therapy; NPWT; Vacuum therapy; VAC

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Negative pressure

EXPERIMENTAL

Negative pressure system is applied with negative pressure (Active) at a participant's unilateral arm

Device: Negative Pressure System

No negative pressure

NO INTERVENTION

Negative pressure system is applied without negative pressure (Inactive) at a participant's contralateral arm

Interventions

Negative Pressure System DEVICE

Negative Pressure System is a non-invasive system that applies sub-atmospheric(Negative) pressure, through a foam and an air-tight film dressing which is connected by suction tubes to a controller unit by which the primary negative pressure can be adjusted.

Negative pressure

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ahmed Aljomah: lead

Study Sites (1)

King Faisal Specialist Hospital & Research Centre

Riyadh, 12713, Saudi Arabia

Location

Related Publications (9)

• Argenta LC, Morykwas MJ. Vacuum-assisted closure: a new method for wound control and treatment: clinical experience. Ann Plast Surg. 1997 Jun;38(6):563-76; discussion 577.

  PMID: 9188971 BACKGROUND

• Morykwas MJ, Argenta LC, Shelton-Brown EI, McGuirt W. Vacuum-assisted closure: a new method for wound control and treatment: animal studies and basic foundation. Ann Plast Surg. 1997 Jun;38(6):553-62. doi: 10.1097/00000637-199706000-00001.

  PMID: 9188970 BACKGROUND

• Morykwas MJ, Faler BJ, Pearce DJ, Argenta LC. Effects of varying levels of subatmospheric pressure on the rate of granulation tissue formation in experimental wounds in swine. Ann Plast Surg. 2001 Nov;47(5):547-51. doi: 10.1097/00000637-200111000-00013.

  PMID: 11716268 BACKGROUND

• Vikatmaa P, Juutilainen V, Kuukasjarvi P, Malmivaara A. Negative pressure wound therapy: a systematic review on effectiveness and safety. Eur J Vasc Endovasc Surg. 2008 Oct;36(4):438-48. doi: 10.1016/j.ejvs.2008.06.010. Epub 2008 Aug 3.

  PMID: 18675559 BACKGROUND

• Ubbink DT, Westerbos SJ, Nelson EA, Vermeulen H. A systematic review of topical negative pressure therapy for acute and chronic wounds. Br J Surg. 2008 Jun;95(6):685-92. doi: 10.1002/bjs.6238.

  PMID: 18446777 BACKGROUND

• Kairinos N, Solomons M, Hudson DA. Negative-pressure wound therapy I: the paradox of negative-pressure wound therapy. Plast Reconstr Surg. 2009 Feb;123(2):589-598. doi: 10.1097/PRS.0b013e3181956551.

  PMID: 19182617 BACKGROUND

• Kairinos N, Voogd AM, Botha PH, Kotze T, Kahn D, Hudson DA, Solomons M. Negative-pressure wound therapy II: negative-pressure wound therapy and increased perfusion. Just an illusion? Plast Reconstr Surg. 2009 Feb;123(2):601-612. doi: 10.1097/PRS.0b013e318196b97b.

  PMID: 19182619 BACKGROUND

• Othman D. Negative pressure wound therapy literature review of efficacy, cost effectiveness, and impact on patients' quality of life in chronic wound management and its implementation in the United kingdom. Plast Surg Int. 2012;2012:374398. doi: 10.1155/2012/374398. Epub 2012 May 30.

  PMID: 22701169 BACKGROUND

• Moues CM, Heule F, Hovius SE. A review of topical negative pressure therapy in wound healing: sufficient evidence? Am J Surg. 2011 Apr;201(4):544-56. doi: 10.1016/j.amjsurg.2010.04.029.

  PMID: 21421104 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Muhammad M Hammami, MD, PHD

  King Faisal Specialist Hospital & Research Center

  PRINCIPAL INVESTIGATOR

• Ahmed S Aljomah, MD

  King Faisal Specialist Hospital & Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Associate

Model Details: 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.

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 30, 2018
• Study Start: July 25, 2018
• Primary Completion: September 4, 2018
• Study Completion: September 4, 2018
• Last Updated: October 26, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: starting 6 months after publication
• Access Criteria: open access after publication

Locations

SA (1)