Ulcer, Wounds and Injuries
Conditions
Brief summary
The purpose of this study is to evaluate the feasibility and usability of a new portable and compact wound dressing device for the treatment of small chronic skin wounds.
Detailed description
This is an open label study
Interventions
DEVICESNaP Advanced Wound Care System
Application of negative pressure device daily per instructions
OTHERSNaP
Daily use
Sponsors
3M
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Venous stasis ulcer or other chronic wound on the lower extremity that is \>1.5cm and \<10cm at widest point * The wound must have at least 2 cm of intact epithelium surrounding it. * A wound such as a pressure ulcer or chronic ulcer on a location other than the lower extremity may also be included in the study if it meets the size requirements and a reliable seal can be achieved. * Ulcer must not have healed for \>14 days under standard treatment. * Chronic wound with prior graft placement will be allowed in the study. * Patient is \>18 years old. * Willing and able to sign informed consent.
Exclusion criteria
- Active wound infection. * 3+ or greater pitting edema of lower extremity * History of malignancy at wound site. However, wounds that are closing by secondary intent after surgical clearance of prior tumor will be allowed in the study. * Thick eschar at wound base after debridement. * Wound location is not amenable to forming an airtight seal and placement of device. * Ulcers due to inflammatory conditions such as pyoderma gangrenosum, rheumatoid arthritis, vasculitis, cryoglobulinemia, necrobiosis lipoidica diabeticorum, lupus or pancreatic panniculitis, cryofibrinogenemia, calcinosis cutis, scleroderma, Raynaud's syndrome. * Current smoker (must have quit for \>3 weeks) * Wound with exposed bone, blood vessels, tendon * Significant immunosuppression (as determined by the investigator and sponsor) such as high dose prednisone * Fasting blood sugar \>200 by study personnel administered bedside fingerstick blood glucose * Ankle brachial index less than lower limit of normal (\<0.60) as performed and determined by licensed physician (necessary only for patients with lower extremity wounds). * Pregnancy * Incapable of giving informed consent * Inability to comply with study procedures including lack of telephone access for week 8 telephone survey
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ease of Use for Patients | Baseline up to 31 days | Participants were given instructions to use the SNaP device home. Participants completed a questionnaire reporting whether the device was easy to use, worthwhile to use, and whether they would use the device again. Numbers responding positively to each question are presented. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Open Label Single Arm Study Eligible participants | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Open Label Single Arm Study |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Age, Continuous | 55 years |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Ease of Use for Patients
Participants were given instructions to use the SNaP device home. Participants completed a questionnaire reporting whether the device was easy to use, worthwhile to use, and whether they would use the device again. Numbers responding positively to each question are presented.
Time frame: Baseline up to 31 days
Population: All participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Open Label Single Arm Study | Ease of Use for Patients | Easy to use | 8 participants |
| Open Label Single Arm Study | Ease of Use for Patients | Worthwhile to use | 10 participants |
| Open Label Single Arm Study | Ease of Use for Patients | I would use this device again | 9 participants |