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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:
Information provided by (Responsible Party):
Spiracur, Inc.
ClinicalTrials.gov Identifier:
NCT01349894
First received: May 5, 2011
Last updated: December 11, 2012
Last verified: December 2012
History of Changes
  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:

MedlinePlus related topics: Cancer Skin Cancer
U.S. FDA Resources

Further study details as provided by Spiracur, Inc.:

Primary Outcome Measures:
  • Wound Closure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Spiracur, Inc.
ClinicalTrials.gov Identifier: NCT01349894     History of Changes
Other Study ID Numbers: 011111
Study First Received: May 5, 2011
Last Updated: December 11, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013