WithdrawnNot Applicable

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

Stopped: The study was terminated by Spiracur (original sponsor). Efforts were made to contact the PI/study team members, but were unsuccessful.

United States0Started 2011-08

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Wound Closure

Timeframe: 12 weeks

Trial details

NCT IDNCT01349894

SponsorSolventum US LLC

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2012-06

View on ClinicalTrials.gov More Split Thickness Skin Graft trials