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Post-Market Clinical Evaluation of the Spiracur SNaP™ Wound Care System for Treatment of Skin Cancer Excision Sites and Split Thickness Skin Grafts


N/A
18 Years
N/A
Not Enrolling
Both
Split Thickness Skin Graft, Skin Cancer Excision Site, Skin Graft

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Trial Information

Post-Market Clinical Evaluation of the Spiracur SNaP™ Wound Care System for Treatment of Skin Cancer Excision Sites and Split Thickness Skin Grafts


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort

Outcome Measure:

Wound Closure

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Francis Papay, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Institutional Review Board

Study ID:

011111

NCT ID:

NCT01349894

Start Date:

August 2011

Completion Date:

June 2012

Related Keywords:

  • Split Thickness Skin Graft
  • Skin Cancer Excision Site
  • Skin Graft
  • Skin Neoplasms

Name

Location

Dermatology and Plastic Surgery Institute, Cleveland ClinicCleveland, Ohio  44195