Back to resultsEvaluation of a Novel Post-Surgical Dressing
Primary Purpose
Post Surgical Wound
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ciSNaP
Sponsored by
About this trial
This is an interventional treatment trial for Post Surgical Wound
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- El Camino Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ciSNaP
Arm Description
Outcomes
Primary Outcome Measures
Frequency of Complaints About Device Use and Operation
Frequency of complaints about device use and operation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01831596
Brief Title
Evaluation of a Novel Post-Surgical Dressing
Official Title
Evaluation of a Novel Post-Surgical Dressing
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated by Spiracur. Efforts were made to contact the PI/study team members, but were unsuccessful.
Study Start Date
November 2010 (Actual)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3M
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of the Closed-Incision SNaP Device.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Surgical Wound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ciSNaP
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
ciSNaP
Intervention Description
SNaP disposable, mechanically powered Negative Pressure Wound Therapy System
Primary Outcome Measure Information:
Title
Frequency of Complaints About Device Use and Operation
Description
Frequency of complaints about device use and operation
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
El Camino Hospital
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of a Novel Post-Surgical Dressing
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