Trauma-related WoundNCT01417234
Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System for Treatment of Acute Trauma and Acute Surgical Excision Wounds
An observational study of Trauma-related Wound and Surgical Wound, Recent, run by 3M 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 acute trauma and acute surgical excision wounds. The secondary purpose will be to compare the prospective patients to retrospectively treated acute trauma wounds to further evaluate efficacy and safety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma-related Wound, Surgical Wound, Recent
- What is being tested?
- SNaP® Wound Care System
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Oct 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 exisiting investigator patient population.
Who may be able to join
- Trauma wound, pressure ulcer, post operative wound, colostomy take-down site, or other acute wound deemed appropriate by study investigator(s) as the source of the wound on any part of the body including head and neck, torso, and extremities
- Wound < 16 cm in greatest diameter
- Subject ≥ 18 years of age
- Exudate < 25 ml/ day (estimate)
- 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 > 45 days old
- 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
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- Subject is pregnant
- Subject is actively participating in other clinical trials that conflict with current study
- Subject has fistulas
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the efficacy of the Spiracur SNaP® Wound Care System for the treatment of acute trauma and acute surgical excision wounds. The secondary purpose will be to compare the prospective patients to retrospectively treated acute trauma wounds to further evaluate efficacy and safety.
- Conditions
- Trauma-related Wound, Surgical Wound, Recent
- Being tested
- SNaP® Wound Care System
- Medical subject headings
- Surgical Wound
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
Percent of subjects with study wound deemed closed at 12 weeks
1 wound is studied per participant
Measured: 12 weeks
Secondary outcomes (3)
Percent Wound Size Change
Percent change in wound size from baseline to week 4 (Week 4 - baseline / baseline)
Measured: Baseline and 4 weeks
Percent Wound Size Change
Percent change in wound size from week 4 to week 8 (Week 8 - Week 4 / Week 4)
Measured: 4 weeks and 8 weeks
Percent Wound Size Change
Percent change in wound size from week 8 to week 12 (12 Weeks - 8 weeks / 8 weeks)
Measured: 8 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startJun 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Trauma-related WoundStudies 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
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3M
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01417234
- Sponsor's protocol ID
- 102110
- Status last verified
- Jul 2022
- First submitted
- 12 Aug 2011
- Last updated
- 1 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. 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 Acute Trauma and Acute Surgical Excision Wounds
- ClinicalTrials.gov ID
- NCT01417234
- Acronym / sponsor ID
- 102110
- Conditions
- Trauma-related Wound, Surgical Wound, Recent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- 3MIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 16 Aug 2011 (estimated)
- Results
- Posted 6 Nov 2020
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 acute trauma and acute surgical excision wounds. The secondary purpose will be to compare the prospective patients to retrospectively treated acute trauma wounds to further evaluate efficacy and safety.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- 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 exisiting investigator patient population.
Key inclusion criteria (6 listed)
- Trauma wound, pressure ulcer, post operative wound, colostomy take-down site, or other acute wound deemed appropriate by study investigator(s) as the source of the wound on any part of the body including head and neck, torso, and extremities
- Wound < 16 cm in greatest diameter
- Subject ≥ 18 years of age
- Exudate < 25 ml/ day (estimate)
- Female subjects of child-bearing potential must be willing to take a urine pregnancy test prior to starting study
Key exclusion criteria (9 listed)
- Wound > 45 days old
- 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
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
Percent of subjects with study wound deemed closed at 12 weeks 1 wound is studied per participant
3 secondary outcomes
Percent Wound Size Change
Time frame: Baseline and 4 weeks
Percent Wound Size Change
Time frame: 4 weeks and 8 weeks
Percent Wound Size Change
Time frame: 8 weeks and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Trauma-related Wound and Surgical Wound, Recent, run by 3M 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 1 Aug 2022. 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?
Yes. Results are posted in the registry (first posted 6 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 1 Aug 2022.