Evaluation of a Novel Post-Surgical Dressing

Not Applicable

Terminated

• Conditions: Post Surgical Wound
• Interventions: Device: ciSNaP

• Registration Number: NCT01831596
• Lead Sponsor: KCI USA, Inc

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of the Closed-Incision SNaP Device.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Study First Submitted: 2013-04-05
• Study First Submitted QC: 2013-04-09
• Study First Posted: 2013-04-15
• Results First Submitted: 2020-09-03
• Results First Submitted QC: 2020-09-25
• Results First Posted: 2020-09-28
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 59

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ciSNaP	ciSNaP	-

Primary Outcome Measures

Name	Time	Method
Frequency of Complaints About Device Use and Operation	30 days	Frequency of complaints about device use and operation

Trial Locations

Locations (1)

El Camino Hospital; 🇺🇸 Mountain View, California, United States