Evaluation of a Novel Post-Surgical Dressing

November 21, 2024 updated by: KCI USA, Inc
The purpose of this study is to evaluate the safety and efficacy of the Closed-Incision SNaP Device.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Mountain View, California, United States, 94040
        • El Camino Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ciSNaP
Device: ciSNaP
SNaP disposable, mechanically powered Negative Pressure Wound Therapy System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Complaints About Device Use and Operation
Time Frame: 30 days
Frequency of complaints about device use and operation
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KCI USA, Inc

Collaborators

3M

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

April 5, 2013

First Submitted That Met QC Criteria

April 9, 2013

First Posted (Estimated)

April 15, 2013

Study Record Updates

Last Update Posted (Actual)

November 25, 2024

Last Update Submitted That Met QC Criteria

November 21, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 030110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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