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

Skin Graft Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01349894
• Other study ID #: 011111
• Status: Withdrawn
• Start date: August 2011
• Est. completion date: June 2012

Study information

• Verified date: July 2022
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• SNaP® Wound Care System
Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.

Locations

Country	Name	City	State
United States	Dermatology and Plastic Surgery Institute, Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
3M

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound Closure		12 weeks