SNaP Wound Care System Over Skin Cancer Excision Sites and Split Thickness Skin Grafts (STSGs)
This study has been completed.
Information provided by (Responsible Party):
First received: May 5, 2011
Last updated: December 11, 2012
Last verified: December 2012
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.
Split Thickness Skin Graft
Skin Cancer Excision Site
Device: SNaP® Wound Care System
||Observational Model: Cohort
||Post-Market Clinical Evaluation of the Spiracur SNaP™ Wound Care System for Treatment of Skin Cancer Excision Sites and Split Thickness Skin Grafts
Primary Outcome Measures:
- Wound Closure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2012 (Final data collection date for primary outcome measure)
SNaP® Wound Care System
Device: SNaP® Wound Care System
Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Study population will be selected from existing investigator patient population.
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01349894
|Dermatology and Plastic Surgery Institute, Cleveland Clinic
|Cleveland, Ohio, United States, 44195 |
||Francis Papay, MD
||The Cleveland Clinic
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 5, 2011
||December 11, 2012
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 20, 2014
Neoplasms by Site