Study Stopped
The study was terminated by Spiracur (original sponsor). Efforts were made to contact the PI/study team members, but were unsuccessful.
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
1 other identifier
observational
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2011
CompletedFirst Posted
Study publicly available on registry
May 9, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedOctober 2, 2024
September 1, 2024
10 months
May 5, 2011
September 30, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Wound Closure
12 weeks
Study Arms (1)
SNaP® Wound Care System
Interventions
Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
Eligibility Criteria
Study population will be selected from existing investigator patient population.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Solventum US LLClead
- 3Mcollaborator
Study Sites (1)
Dermatology and Plastic Surgery Institute, Cleveland Clinic
Cleveland, Ohio, 44195, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Francis Papay, MD
The Cleveland Clinic
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2011
First Posted
May 9, 2011
Study Start
August 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
October 2, 2024
Record last verified: 2024-09