Surgical Wound, Recent, Trauma-related Wound
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of the Spiracur SNaP® Wound Care System for the treatment of acute trauma and acute surgical excision wounds. The secondary purpose will be to compare the prospective patients to retrospectively treated acute trauma wounds to further evaluate efficacy and safety.
Interventions
DEVICESNaP® Wound Care System
Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
Sponsors
3M
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Trauma wound, pressure ulcer, post operative wound, colostomy take-down site, or other acute wound deemed appropriate by study investigator(s) as the source of the wound on any part of the body including head and neck, torso, and extremities * Wound \< 16 cm in greatest diameter * Subject ≥ 18 years of age * Exudate \< 25 ml/ day (estimate) * Female subjects of child-bearing potential must be willing to take a urine pregnancy test prior to starting study * Subject is willing and able to sign informed consent
Exclusion criteria
* Wound \> 45 days old * Wound-related cellulitis * Wound located in an area not amenable to forming an air-tight seal * Subject has untreated osteomyelitis * Subject is allergic to wound care products * Wound has exposed blood vessels not suitable for negative pressure therapy * Subject is pregnant * Subject is actively participating in other clinical trials that conflict with current study * Subject has fistulas
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Closure | 12 weeks | Percent of subjects with study wound deemed closed at 12 weeks 1 wound is studied per participant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Wound Size Change | Baseline and 4 weeks | Percent change in wound size from baseline to week 4 (Week 4 - baseline / baseline) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SNaP® Wound Care System SNaP® Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Subject non-compliant | 3 |
Baseline characteristics
| Characteristic | SNaP® Wound Care System |
|---|---|
| Age, Customized Age | 55 years STANDARD_DEVIATION 11.94 |
| Race/Ethnicity, Customized Caucasian | 12 Participants |
| Race/Ethnicity, Customized Unknown | 18 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Wound Closure
Percent of subjects with study wound deemed closed at 12 weeks 1 wound is studied per participant
Time frame: 12 weeks
Population: Per protocol population used for analysis. 3 subjects withdrew from study early due to non-compliance with study therapy and were not included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SNaP® Wound Care System | Wound Closure | 22 Participants |
Secondary
Percent Wound Size Change
Percent change in wound size from baseline to week 4 (Week 4 - baseline / baseline)
Time frame: Baseline and 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SNaP® Wound Care System | Percent Wound Size Change | -41 percent change | Standard Deviation 0.43 |
Secondary
Percent Wound Size Change
Percent change in wound size from week 4 to week 8 (Week 8 - Week 4 / Week 4)
Time frame: 4 weeks and 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SNaP® Wound Care System | Percent Wound Size Change | -18.2 percent change | Standard Deviation 0.39 |
Secondary
Percent Wound Size Change
Percent change in wound size from week 8 to week 12 (12 Weeks - 8 weeks / 8 weeks)
Time frame: 8 weeks and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SNaP® Wound Care System | Percent Wound Size Change | -3.6 percent change | Standard Deviation 0.11 |