Evaluation of a Novel Post-Surgical Dressing

KCI USA, Inc

Status: Terminated

Conditions: Post Surgical Wound

Treatments: Device: ciSNaP

Study type: Interventional

Funder types: Industry

Identifiers

NCT01831596

030110

Details and patient eligibility

About

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

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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59 participants in 1 patient group

ciSNaP

Experimental group

Treatment:

Device: ciSNaP