Trial Outcomes & Findings for Simplified Negative Pressure Wound Therapy (NCT NCT01339429)
NCT ID: NCT01339429
Last Updated: 2015-05-20
Results Overview
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.
COMPLETED
PHASE1
41 participants
3 days
2015-05-20
Participant Flow
Hospital wards were surveyed daily over the study period for eligible patients. Photographs of wounds ranging from 2-150 cm2 in size and clinical histories were reviewed for study enrollment eligibility criteria.
47 patients consented. 6 did not meet inclusion criteria. 1 voluntarily withdrew. 4 not enrolled due to clinical changes.
Participant milestones
| Measure |
Simplified Negative Pressure Wound Therapy
The simplified negative pressure wound therapy device was placed on subjects selected from hospital wards and meeting the eligibility criteria regarding wound size and condition. Inclusion criteria included age 14 years or older, adequate adjacent intact skin and wound location for application of the sNPWT dressing, adequate pain control, and anticipated clinically stability and hospitalization for the duration of the study. Exclusion criteria were exposed blood vessels, evidence of ischemia, necrotic tissue requiring further debridement, infection, osteomyelitis, and malignancy in the wound.
Simplified negative pressure wound therapy device: A non-powered negative pressure wound therapy device utilizing a bellows connected to a specialized dressing via a drainage tube.
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|---|---|
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Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Simplified Negative Pressure Wound Therapy
The simplified negative pressure wound therapy device was placed on subjects selected from hospital wards and meeting the eligibility criteria regarding wound size and condition. Inclusion criteria included age 14 years or older, adequate adjacent intact skin and wound location for application of the sNPWT dressing, adequate pain control, and anticipated clinically stability and hospitalization for the duration of the study. Exclusion criteria were exposed blood vessels, evidence of ischemia, necrotic tissue requiring further debridement, infection, osteomyelitis, and malignancy in the wound.
Simplified negative pressure wound therapy device: A non-powered negative pressure wound therapy device utilizing a bellows connected to a specialized dressing via a drainage tube.
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|---|---|
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Overall Study
Withdrawal by Subject
|
1
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Overall Study
Physician Decision
|
3
|
Baseline Characteristics
Simplified Negative Pressure Wound Therapy
Baseline characteristics by cohort
| Measure |
Simplified Negative Pressure Wound Therapy
n=41 Participants
The simplified Negative Pressure device will be placed on subjects selected from the hospital wards and meeting the eligibility criteria.
simplified Negative Pressure device: A non-powered negative pressure device utilizing a bellows which is compressed every eight hours.
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|---|---|
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Age, Customized
14 to 90 Years
|
41 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
2 participants
n=5 Participants
|
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Sex/Gender, Customized
Female
|
2 participants
n=5 Participants
|
|
Sex/Gender, Customized
Unknown
|
37 participants
n=5 Participants
|
|
Region of Enrollment
Rwanda
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 daysPopulation: 85 dressings were applied. 5 applications excluded due to a change in patient condition, unrelated to sNPWT. 9 dressings excluded due to occlusion of the drainage tube. 71 dressings were analyzed in total.
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.
Outcome measures
| Measure |
Simplified Negative Pressure Wound Therapy
n=71 dressings
The simplified negative pressure wound therapy device will be placed on subjects selected from the surgical ward and meeting the eligibility criteria regarding wound size and condition.
Simplified negative pressure wound therapy device: A non-powered negative pressure wound therapy device utilizing a bellows connected to a specialized dressing.
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|---|---|
|
Maintenance of Negative Pressure
|
22.2 hours
Standard Deviation 27.0
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SECONDARY outcome
Timeframe: 3 daysAny adverse events, including bleeding, wound complication, or change in patient condition during the trial period will be recorded.
Outcome measures
| Measure |
Simplified Negative Pressure Wound Therapy
n=71 dressings
The simplified negative pressure wound therapy device will be placed on subjects selected from the surgical ward and meeting the eligibility criteria regarding wound size and condition.
Simplified negative pressure wound therapy device: A non-powered negative pressure wound therapy device utilizing a bellows connected to a specialized dressing.
|
|---|---|
|
Number of Participants With Serious Adverse Events
|
0 participants
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Adverse Events
Simplified Negative Pressure Wound Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Simplified Negative Pressure Wound Therapy
n=41 participants at risk
The simplified negative pressure wound therapy device was placed on subjects selected from the hospital wards and meeting the eligibility criteria regarding wound size and condition.
Simplified negative pressure wound therapy device: A non-powered negative pressure wound therapy device utilizing a bellows connected to a specialized dressing.
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|---|---|
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Immune system disorders
Fever
|
2.4%
1/41 • Number of events 1
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place