Evaluation of a Novel Post-Surgical Dressing

Post Surgical Wound Clinical Trial

Official title:

Evaluation of a Novel Post-Surgical Dressing

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01831596
• Other study ID #: 030110
• Status: Terminated
• Phase: N/A
• Start date: November 2010
• Est. completion date: June 2012

Study information

• Verified date: July 2022
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 59
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Post Surgical Wound
• Surgical Wound

Intervention

Device:
• ciSNaP
SNaP disposable, mechanically powered Negative Pressure Wound Therapy System

Locations

Country	Name	City	State
United States	El Camino Hospital	Mountain View	California

Sponsors (1)

Lead Sponsor	Collaborator
3M

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Complaints About Device Use and Operation	Frequency of complaints about device use and operation	30 days