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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Recruitment Status : Withdrawn (The study was terminated by Spiracur (original sponsor).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.

Tracking Information
First Submitted Date May 5, 2011
First Posted Date May 9, 2011
Last Update Posted Date September 7, 2020
Actual Study Start Date August 2011
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 11, 2012)
Wound Closure [ Time Frame: 12 weeks ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title SNaP Wound Care System Over Skin Cancer Excision Sites and Split Thickness Skin Grafts (STSGs)
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Study population will be selected from existing investigator patient population.
Condition
  • Split Thickness Skin Graft
  • Skin Cancer Excision Site
  • Skin Graft
Intervention Device: SNaP® Wound Care System
Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
Study Groups/Cohorts SNaP® Wound Care System
Intervention: Device: SNaP® Wound Care System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: September 3, 2020)
0
Original Estimated Enrollment
 (submitted: May 6, 2011)
30
Actual Study Completion Date June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01349894
Other Study ID Numbers 011111
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party KCI USA, Inc.
Study Sponsor KCI USA, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Francis Papay, MD The Cleveland Clinic
PRS Account KCI USA, Inc.
Verification Date September 2020