Negative Pressure Wound TherapyNCT03512444
Does Circumferential Negative Pressure Therapy Impair Distal O2 Saturation?
A study testing Negative Pressure System in people with Negative Pressure Wound Therapy and Wound, run by Ahmed Aljomah at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Negative Pressure Wound Therapy, Wound
- What is being tested?
- Negative Pressure System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 25 Jul 2018to 4 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Faisal Specialist Hospital & Research Centre
Riyadh, 12713
About this study
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.
Read the 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.
- Conditions
- Negative Pressure Wound Therapy, Wound
- Being tested
- Negative Pressure System
- Keywords
- negative pressure therapy, negative pressure, Wound therapy, NPWT, Vacuum therapy, VAC
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Pressure SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Negative pressure | Experimental | Negative pressure system is applied with negative pressure (Active)
at a participant's unilateral arm Receives: Device: Negative Pressure System |
| No negative pressure | No intervention | Negative pressure system is applied without negative pressure (Inactive) at a participant's contralateral arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start25 Jul 2018
- Primary completion4 Sep 2018
- Study completion4 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Negative Pressure Wound TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Aljomah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Aljomah, King Faisal Specialist Hospital & Research Center
- Investigators
- Muhammad M Hammami, MD, PHD, Principal investigator, King Faisal Specialist Hospital & Research CenterAhmed S Aljomah, MD, Principal investigator, King Faisal Specialist Hospital & Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512444
- Sponsor's protocol ID
- 2181026
- Status last verified
- Oct 2018
- First submitted
- 9 Apr 2018
- Last updated
- 26 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: all collected IPD.
Publications
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.
PubMed 9188971Morykwas 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.
PubMed 9188970Morykwas 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.
PubMed 11716268Vikatmaa 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.
PubMed 18675559Ubbink 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.
PubMed 18446777Kairinos 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.
PubMed 19182617Kairinos 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.
PubMed 19182619Othman 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.
PubMed 22701169Moues 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.
PubMed 21421104
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Circumferential Negative Pressure Therapy Impair Distal O2 Saturation? A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03512444
- Acronym / sponsor ID
- 2181026
- Conditions
- Negative Pressure Wound Therapy, Wound
- Keywords
- negative pressure therapy, negative pressure, Wound therapy, NPWT, Vacuum therapy, VAC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Ahmed AljomahUniversity, hospital or other
- Study start
- 25 Jul 2018 (actual)
- Primary completion
- 4 Sep 2018 (actual)
- Study completion
- 4 Sep 2018 (actual)
- First posted
- 30 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Negative pressure | Experimental | Device: Negative Pressure SystemNegative pressure system is applied with negative pressure (Active) at a participant's unilateral arm |
| No negative pressure | No intervention | –Negative pressure system is applied without negative pressure (Inactive) at a participant's contralateral arm |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (7 listed)
- Unhealthy individual
- Chronic conditions
- History of upper limb diseases or defects.
- History of upper limb Surgical intervention.
- History of upper limb implants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative Pressure SystemNegative 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. | Device | Negative pressure |
Primary outcome
Area under the curve (AUC) of index finger O2 saturation over 9 hours.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
- Background: PubMed 9188971Argenta 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.
- Background: PubMed 9188970Morykwas 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.
- Background: PubMed 11716268Morykwas 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.
- Background: PubMed 18675559Vikatmaa 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.
- Background: PubMed 18446777Ubbink 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.
- Background: PubMed 19182617Kairinos 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.
- Background: PubMed 19182619Kairinos 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.
- Background: PubMed 22701169Othman 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.
- Background: PubMed 21421104Moues 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.
- Individual participant dataSharing planned: Yes. all collected IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad M Hammami, MD, PHD principal investigator
King Faisal Specialist Hospital & Research Center
Ahmed S Aljomah, MD principal investigator
King Faisal Specialist Hospital & Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative Pressure System in people with Negative Pressure Wound Therapy and Wound, run by Ahmed Aljomah at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (AUC) of index finger O2 saturation over 9 hours. (time frame: 9 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03512444, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2018.