Overview

This trial is active, not recruiting.

Condition post surgical wound
Treatment cisnap
Sponsor Spiracur, Inc.
Start date June 2010
End date June 2014
Trial size 120 participants
Trial identifier NCT01831596, 030110

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
cisnap

Primary Outcomes

Measure
Frequency of complaints about device use and operation
time frame: 30 days

Secondary Outcomes

Measure
Rate of wound healing complications
time frame: 30 days

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Evaluation of a Novel Post-Surgical Dressing
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by Spiracur, Inc..