Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System for Treatment of Acute Trauma and Acute Surgical Excision Wounds
1 other identifier
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 12, 2011
CompletedFirst Posted
Study publicly available on registry
August 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedResults Posted
Study results publicly available
November 6, 2020
CompletedAugust 1, 2022
July 1, 2022
1.3 years
August 12, 2011
September 16, 2020
July 29, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Wound Closure
Percent of subjects with study wound deemed closed at 12 weeks 1 wound is studied per participant
12 weeks
Secondary Outcomes (3)
Percent Wound Size Change
Baseline and 4 weeks
Percent Wound Size Change
4 weeks and 8 weeks
Percent Wound Size Change
8 weeks and 12 weeks
Study Arms (1)
SNaP® Wound Care System
Interventions
Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
Eligibility Criteria
Study population will be selected from exisiting investigator patient population.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- 3Mlead
Study Sites (1)
Cleveland Clinic
Cleveland, Ohio, 41955, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- VP, Global Clinical Development
- Organization
- KCI
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2011
First Posted
August 16, 2011
Study Start
June 1, 2011
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
August 1, 2022
Results First Posted
November 6, 2020
Record last verified: 2022-07