Study Stopped
The study was terminated by Spiracur. Efforts were made to contact the PI/study team members, but were unsuccessful.
Evaluation of a Novel Post-Surgical Dressing
1 other identifier
interventional
59
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of the Closed-Incision SNaP Device.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 5, 2013
CompletedFirst Posted
Study publicly available on registry
April 15, 2013
CompletedResults Posted
Study results publicly available
September 28, 2020
CompletedNovember 25, 2024
November 1, 2024
1.6 years
April 5, 2013
September 3, 2020
November 21, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Frequency of Complaints About Device Use and Operation
Frequency of complaints about device use and operation
30 days
Study Arms (1)
ciSNaP
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Surgically closed incision.
- Subject is 18 years of age or older.
- Subject consents to follow-up per protocol.
- Willing and able to sign informed consent.
You may not qualify if:
- Subject is allergic to wound care products used in this study.
- Subject has wounds with exposed blood vessels not suitable for negative pressure therapy.
- Pregnant or pregnancy-suspected subject.
- Subject actively participating in other clinical trials that conflict with the current study.
- Subject is unable or unwilling to comply with protocol requirements.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KCI USA, Inclead
- 3Mcollaborator
Study Sites (1)
El Camino Hospital
Mountain View, California, 94040, United States
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
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2013
First Posted
April 15, 2013
Study Start
November 1, 2010
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
November 25, 2024
Results First Posted
September 28, 2020
Record last verified: 2024-11