Trial Outcomes & Findings for Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System for Treatment of Acute Trauma and Acute Surgical Excision Wounds (NCT NCT01417234)

NCT ID: NCT01417234

Last Updated: 2022-08-01

Results Overview

Percent of subjects with study wound deemed closed at 12 weeks 1 wound is studied per participant

• Recruitment status: COMPLETED
• Target enrollment: 30 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2022-08-01

Participant Flow

Participant milestones

Measure	SNaP® Wound Care System SNaP® Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
Overall Study STARTED	30
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	SNaP® Wound Care System SNaP® Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
Overall Study Subject non-compliant	3

Baseline Characteristics

Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System for Treatment of Acute Trauma and Acute Surgical Excision Wounds

Baseline characteristics by cohort

Measure	SNaP® Wound Care System n=30 Participants SNaP® Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
Age, Customized Age	55 years STANDARD_DEVIATION 11.94 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	12 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	18 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Percent of subjects with study wound deemed closed at 12 weeks

1 wound is studied per participant

Outcome measures

Measure	SNaP® Wound Care System n=27 Participants SNaP® Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
Wound Closure	22 Participants

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Percent change in wound size from baseline to week 4 (Week 4 - baseline / baseline)

Outcome measures

Measure	SNaP® Wound Care System n=30 Participants SNaP® Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
Percent Wound Size Change	-41 percent change Standard Deviation 0.43

SECONDARY outcome

Timeframe: 4 weeks and 8 weeks

Percent change in wound size from week 4 to week 8 (Week 8 - Week 4 / Week 4)

Outcome measures

Measure	SNaP® Wound Care System n=30 Participants SNaP® Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
Percent Wound Size Change	-18.2 percent change Standard Deviation 0.39

SECONDARY outcome

Timeframe: 8 weeks and 12 weeks

Percent change in wound size from week 8 to week 12 (12 Weeks - 8 weeks / 8 weeks)

Outcome measures

Measure	SNaP® Wound Care System n=30 Participants SNaP® Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
Percent Wound Size Change	-3.6 percent change Standard Deviation 0.11

Adverse Events

SNaP® Wound Care System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

VP, Global Clinical Development

KCI

Phone: 12102555595

Email: jane.hart@acelity.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place