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

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.
 
ClinicalTrials.gov Identifier: NCT01349894
Recruitment Status : Withdrawn (The study was terminated by Spiracur (original sponsor). Efforts were made to contact the PI/study team members, but were unsuccessful.)
First Posted : May 9, 2011
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
KCI USA, Inc.

Brief Summary:
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 or disease Intervention/treatment
Split Thickness Skin Graft Skin Cancer Excision Site Skin Graft Device: SNaP® Wound Care System

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Other
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
Actual Study Start Date : August 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
SNaP® Wound Care System Device: SNaP® Wound Care System
Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.




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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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
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United States, Ohio
Dermatology and Plastic Surgery Institute, Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
KCI USA, Inc.
Investigators
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Principal Investigator: Francis Papay, MD The Cleveland Clinic
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Responsible Party: KCI USA, Inc.
ClinicalTrials.gov Identifier: NCT01349894    
Other Study ID Numbers: 011111
First Posted: May 9, 2011    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases