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SNaP Wound Care System Over Skin Cancer Excision Sites and Split Thickness Skin Grafts (STSGs)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01349894
First Posted: May 9, 2011
Last Update Posted: December 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Spiracur, Inc.
  Purpose
The purpose of this study is to evaluate the efficacy of the Spiracur SNaP® Wound Care System for the treatment of skin cancer excision sites and split thickness skin grafts (STSG). The secondary purpose will be to compare the prospective patients to retrospectively treated skin cancer excision sites and STSGs to further evaluate efficacy and safety.

Condition Intervention
Split Thickness Skin Graft Skin Cancer Excision Site Skin Graft Device: SNaP® Wound Care System

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Post-Market Clinical Evaluation of the Spiracur SNaP™ Wound Care System for Treatment of Skin Cancer Excision Sites and Split Thickness Skin Grafts

Resource links provided by NLM:


Further study details as provided by Spiracur, Inc.:

Primary Outcome Measures:
  • Wound Closure [ Time Frame: 12 weeks ]

Enrollment: 7
Study Start Date: August 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
SNaP® Wound Care System Device: SNaP® Wound Care System
Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study population will be selected from existing investigator patient population.
Criteria

Inclusion Criteria:

  • Skin cancer excision site and/or STSG as the source of the wound on any part of the body including head and neck, torso, and extremities. Any other type of skin graft will also be eligible for inclusion into the study.
  • Wound < 16 cm in greatest diameter
  • Subject ≥ 18 years of age
  • Female subjects of child-bearing potential must be willing to take a urine pregnancy test prior to starting study
  • Subject is willing and able to sign informed consent

Exclusion Criteria:

  • Wound-related cellulitis
  • Wound located in an area not amenable to forming an air-tight seal
  • Subject has untreated osteomyelitis
  • Subject is allergic to wound care products
  • Wound has exposed blood vessels not suitable for negative pressure therapy
  • Subject is actively participating in other clinical trials that conflict with current study
  • Subject has fistulas
  • Subject is pregnant
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01349894


Locations
United States, Ohio
Dermatology and Plastic Surgery Institute, Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Spiracur, Inc.
Investigators
Principal Investigator: Francis Papay, MD The Cleveland Clinic
  More Information

Responsible Party: Spiracur, Inc.
ClinicalTrials.gov Identifier: NCT01349894     History of Changes
Other Study ID Numbers: 011111
First Submitted: May 5, 2011
First Posted: May 9, 2011
Last Update Posted: December 12, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases