Split Thickness Skin GraftNCT01349894
SNaP Wound Care System Over Skin Cancer Excision Sites and Split Thickness Skin Grafts (STSGs)
An observational study of Split Thickness Skin Graft and Skin Cancer Excision Site, run by Solventum US LLC at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Split Thickness Skin Graft, Skin Cancer Excision Site, Skin Graft
- What is being tested?
- SNaP® Wound Care System
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population will be selected from existing investigator patient population.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dermatology and Plastic Surgery Institute, Cleveland Clinic
Cleveland, Ohio, 44195
About this study
Official title: Post-Market Clinical Evaluation of the Spiracur SNaP™ Wound Care System for Treatment of Skin Cancer Excision Sites and Split Thickness Skin Grafts
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.
- Being tested
- SNaP® Wound Care System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNaP® Wound Care SystemDevice
Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
| Study group | Role | What they receive |
|---|---|---|
| SNaP® Wound Care System | Not described Receives: Device: SNaP® Wound Care System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Closure
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2011 (estimated)
- Study startAug 2011
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: The study was terminated by Spiracur (original sponsor). Efforts were made to contact the PI/study team members, but were unsuccessful.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Split Thickness Skin GraftStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Responsible party
- Sponsor
- Investigators
- Francis Papay, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01349894
- Sponsor's protocol ID
- 011111
- Status last verified
- Sep 2024
- First submitted
- 5 May 2011
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Evaluation of the Spiracur SNaP™ Wound Care System for Treatment of Skin Cancer Excision Sites and Split Thickness Skin Grafts
- ClinicalTrials.gov ID
- NCT01349894
- Acronym / sponsor ID
- 011111
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study was terminated by Spiracur (original sponsor). Efforts were made to contact the PI/study team members, but were unsuccessful.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- Aug 2011 (actual)
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 9 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SNaP® Wound Care System | – | Device: SNaP® Wound Care System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will be selected from existing investigator patient population.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNaP® Wound Care SystemWound dressing applications using customized system. Dressing applications changes per manufacturer recommendation. | Device | SNaP® Wound Care System |
Primary outcome
Wound Closure
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
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Surgical Outcomes of Simple Interrupted Versus Running Epidermal Sutures in Full-thickness Skin Graft Placement
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Autologous Skin Cell Suspension (RECELL®) for Accelerated Healing of Split-Thickness Skin Graft Donor Sites: A Randomized, Intra-Patient (Split-Site) Controlled Trial
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Autologous Fat Grafting Beneath Penile Split Thickness Skin Graft Placement During Penile Reconstruction
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Lower Extremity Graft Study (LEGS): A Multicentre Randomised Controlled Trial of Negative Pressure Wound Therapy Versus Conventional Dressings for Split-thickness Skin Grafts After Lower Leg Skin Tumour Excision
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis Papay, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Split Thickness Skin Graft and Skin Cancer Excision Site, run by Solventum US LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Closure (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.