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

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

Sponsors

Lead Sponsor: KCI USA, Inc.

Source KCI USA, Inc.
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.

Overall Status Withdrawn
Start Date 2011-08-01
Completion Date 2012-06-01
Primary Completion Date 2012-06-01
Study Type Observational
Primary Outcome
Measure Time Frame
Wound Closure 12 weeks
Condition
Intervention

Intervention Type: Device

Intervention Name: SNaP® Wound Care System

Description: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.

Arm Group Label: SNaP® Wound Care System

Eligibility

Sampling Method:

Non-Probability Sample

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Francis Papay, MD Principal Investigator The Cleveland Clinic
Location
Facility: Dermatology and Plastic Surgery Institute, Cleveland Clinic
Location Countries

United States

Verification Date

2020-09-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: SNaP® Wound Care System

Study Design Info

Observational Model: Cohort

Time Perspective: Other

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