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

NCT ID: NCT01349894

Last Updated: 2024-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-06-30

Brief Summary

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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

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Conditions

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Split Thickness Skin Graft Skin Cancer Excision Site Skin Graft

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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SNaP® Wound Care System

SNaP® Wound Care System

Intervention Type DEVICE

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

Interventions

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SNaP® Wound Care System

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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3M

INDUSTRY

Sponsor Role collaborator

Solventum US LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francis Papay, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Dermatology and Plastic Surgery Institute, Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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011111

Identifier Type: -

Identifier Source: org_study_id

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