Wounds
Conditions
Keywords
wound, negative pressure wound therapy, non-powered negative pressure wound therapy
Brief 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. the mechanical properties of the sNPWT device and 2. the adverse events associated with the sNPWT device.
Interventions
DEVICEsimplified negative pressure wound therapy device (Wound Pump device)
A non-powered negative pressure device utilizing a bellows attached to a specialized dressing via drainage tube to promote healing of open wounds.
Sponsors
Center for Integration of Medicine & Innovative Technology
Fogarty International Clinical Research Scholarship
Brigham and Women's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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 * 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maintenance of Negative Pressure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Events | 3 days | Any adverse events, including bleeding, wound complication, or change in patient condition during the trial period will be recorded. |
Countries
Rwanda
Participant flow
Recruitment details
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.
Pre-assignment details
47 patients consented. 6 did not meet inclusion criteria. 1 voluntarily withdrew. 4 not enrolled due to clinical changes.
Participants by arm
| Arm | Count |
|---|---|
| Simplified Negative Pressure Wound Therapy 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. | 41 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Simplified Negative Pressure Wound Therapy |
|---|---|
| Age, Customized 14 to 90 Years | 41 participants |
| Region of Enrollment Rwanda | 41 participants |
| Sex/Gender, Customized Female | 2 participants |
| Sex/Gender, Customized Male | 2 participants |
| Sex/Gender, Customized Unknown | 37 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 41 |
| serious Total, serious adverse events | 0 / 41 |
Outcome results
Primary
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.
Time frame: 3 days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Simplified Negative Pressure Wound Therapy | Maintenance of Negative Pressure | 22.2 hours | Standard Deviation 27 |
Secondary
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.
Time frame: 3 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Simplified Negative Pressure Wound Therapy | Number of Participants With Serious Adverse Events | 0 participants |