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

Withdrawn

• Conditions: Skin Graft; Split Thickness Skin Graft; Skin Cancer Excision Site
• Interventions: Device: SNaP® Wound Care System

• Registration Number: NCT01349894
• Lead Sponsor: Solventum US LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-05
• Study First Submitted QC: 2011-05-06
• Study First Posted: 2011-05-09
• Study Start: 2011-08
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SNaP® Wound Care System	SNaP® Wound Care System	-

Primary Outcome Measures

Name	Time	Method
Wound Closure	12 weeks

Trial Locations

Locations (1)

Dermatology and Plastic Surgery Institute, Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States