SNaP Wound Care System Over Skin Cancer Excision Sites and Split Thickness Skin Grafts (STSGs)
| Status: | Recruiting |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | August 2011 |
| Contact: | Francis Papay, M.D. |
| Phone: | 216-444-6900 |
Post-Market Clinical Evaluation of the Spiracur SNaP™ Wound Care System for Treatment of Skin Cancer Excision Sites and Split Thickness Skin Grafts
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.
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
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