WoundsPhase 1NCT01339429
Simplified Negative Pressure Wound Therapy
A Phase 1 study testing simplified negative pressure wound therapy device (Wound Pump device) in people with Wounds, run by Brigham and Women's Hospital at 2 sites in Rwanda.
Trial summary
The objective of this study is to implement a simplified Negative Pressure Wound Therapy (sNPWT) device in a low resource setting. The investigators hypothesize that the sNPWT device is at least equivalent to commercially available NPWT devices. Therefore, the specific aims of this study will be to measure: 1. Read more about this study
- Who is it for?
- Ages 14 to 90 years
- Conditions the study is for
- Wounds
- What is being tested?
- simplified negative pressure wound therapy device (Wound Pump device)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesRwanda
- Study dates
- Mar 2011to Feb 2012
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- open wound appropriate for NPWT
- wound size greater than 2 cm2 and less than 150 cm2
- adequate adjacent intact skin for application of sNPWT
- adequate contour of wound location for application of sNPWT
- patient is expected to tolerate change of the NPWT dressing with the chosen analgesia and sedation plan by the treating physician
- the patient is expected to remain clinically stable for the duration of the study
Show all 9Show fewer
- the patient is to remain hospitalized for the duration of the study
- patient or their legal representative is willing and able to sign an IRB-approved informed consent
- patient less than 21 years old is willing to sign an approved assent form if able to sign
Who cannot join
- exposed blood vessels
- ischemic wound
- wound with necrotic tissue requiring further debridement at the time of enrollment
- infection
- acute osteomyelitis
- malignancy in the wound
- latex or rubber containing product sensitivity
Trial locations and contacts
2 sites in 1 country.
Rwanda2 sites
Central University Teaching Hospital in Kigali
Kigali, Kigali
Rwinkwavu Hospital
Rwinkwavu, Kayonza District
About this study
Official title: Evaluation of the Performance and Safety of a Simplified Negative Pressure Wound Therapy Device
The objective of this study is to implement a simplified Negative Pressure Wound Therapy (sNPWT) device in a low resource setting. The investigators hypothesize that the sNPWT device is at least equivalent to commercially available NPWT devices. Therefore, the specific aims of this study will be to measure: 1. the mechanical properties of the sNPWT device and 2. the adverse events associated with the sNPWT device.
- Conditions
- Wounds
- Being tested
- simplified negative pressure wound therapy device (Wound Pump device)
- Keywords
- wound, negative pressure wound therapy, non-powered negative pressure wound therapy
- 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.
simplified negative pressure wound therapy device (Wound Pump device)Device
Also called Wound Pump, manufactured by Worldwide Innovative Healthcare, Inc.
A non-powered negative pressure device utilizing a bellows attached to a specialized dressing via drainage tube to promote healing of open wounds.
| Study group | Role | What they receive |
|---|---|---|
| simplified Negative Pressure Wound Therapy | Experimental | The simplified Negative Pressure device will be placed on subjects selected from the hospital ward and meeting the eligibility criteria. Receives: Device: simplified negative pressure wound therapy device (Wound Pump device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance of Negative Pressure
The negative pressure being delivered by the device was measured on a daily basis for three days. Maintenance of negative pressure was defined as negative pressure delivery within 75% of the starting negative pressure amount.
Measured: 3 days
Secondary outcomes (1)
Number of Participants With Serious Adverse Events
Any adverse events, including bleeding, wound complication, or change in patient condition during the trial period will be recorded.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for WoundsStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Integration of Medicine & Innovative Technology, Fogarty International Clinical Research Scholarship
- Responsible party
- Principal investigator, Robert Riviello, Brigham and Women's Hospital
- Investigators
- Robert Riviello, M.D., M.P.H., Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339429
- Sponsor's protocol ID
- 2010-P-002279/1
- Status last verified
- May 2015
- First submitted
- 28 Mar 2011
- Last updated
- 20 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Mody GN, Zurovcik DR, Joharifard S, Kansayisa G, Uwimana G, Baganizi E, Ntakiyiruta G, Mugenzi D, Riviello R. Biomechanical and safety testing of a simplified negative-pressure wound therapy device. Plast Reconstr Surg. 2015 Apr;135(4):1140-1146. doi: 10.1097/PRS.0000000000001101.
PubMed 25502858
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance and Safety of a Simplified Negative Pressure Wound Therapy Device
- ClinicalTrials.gov ID
- NCT01339429
- Acronym / sponsor ID
- 2010-P-002279/1
- Conditions
- Wounds
- Keywords
- wound, negative pressure wound therapy, non-powered negative pressure wound therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Center for Integration of Medicine & Innovative Technology, Fogarty International Clinical Research Scholarship
- Study start
- Mar 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 20 Apr 2011 (estimated)
- Results
- Posted 20 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to implement a simplified Negative Pressure Wound Therapy (sNPWT) device in a low resource setting. The investigators hypothesize that the sNPWT device is at least equivalent to commercially available NPWT devices. Therefore, the specific aims of this study will be to measure: 1. the mechanical properties of the sNPWT device and 2. the adverse events associated with the sNPWT device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| simplified Negative Pressure Wound Therapy | Experimental | Device: simplified negative pressure wound therapy device (Wound Pump device)The simplified Negative Pressure device will be placed on subjects selected from the hospital ward and meeting the eligibility criteria. |
Who may qualify
- Ages
- 14 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- open wound appropriate for NPWT
- wound size greater than 2 cm2 and less than 150 cm2
- adequate adjacent intact skin for application of sNPWT
- adequate contour of wound location for application of sNPWT
- patient is expected to tolerate change of the NPWT dressing with the chosen analgesia and sedation plan by the treating physician
Key exclusion criteria (7 listed)
- exposed blood vessels
- ischemic wound
- wound with necrotic tissue requiring further debridement at the time of enrollment
- infection
- acute osteomyelitis
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 |
|---|---|---|
| simplified negative pressure wound therapy device (Wound Pump device)Also: Wound Pump, manufactured by Worldwide Innovative Healthcare, Inc.A non-powered negative pressure device utilizing a bellows attached to a specialized dressing via drainage tube to promote healing of open wounds. | Device | simplified Negative Pressure Wound Therapy |
Primary outcome
Maintenance of Negative Pressure
Time frame: 3 days
The negative pressure being delivered by the device was measured on a daily basis for three days. Maintenance of negative pressure was defined as negative pressure delivery within 75% of the starting negative pressure amount.
1 secondary outcome
Number of Participants With Serious Adverse Events
Time frame: 3 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25502858Mody GN, Zurovcik DR, Joharifard S, Kansayisa G, Uwimana G, Baganizi E, Ntakiyiruta G, Mugenzi D, Riviello R. Biomechanical and safety testing of a simplified negative-pressure wound therapy device. Plast Reconstr Surg. 2015 Apr;135(4):1140-1146. doi: 10.1097/PRS.0000000000001101.
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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.
Robert Riviello, M.D., M.P.H. principal investigator
Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing simplified negative pressure wound therapy device (Wound Pump device) in people with Wounds, run by Brigham and Women's Hospital at 2 sites in Rwanda.
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 9 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 20 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Rwanda. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maintenance of Negative Pressure (time frame: 3 days). 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 NCT01339429, which also lists 1 linked publication.
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 20 May 2015.