Post Surgical WoundNCT01831596
Evaluation of a Novel Post-Surgical Dressing
A study testing ciSNaP in people with Post Surgical Wound, run by KCI USA, Inc at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of the Closed-Incision SNaP Device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Surgical Wound
- What is being tested?
- ciSNaP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Jun 2012
- Phase
- Interventional
- 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
Who may be able to join
- Surgically closed incision.
- Subject is 18 years of age or older.
- Subject consents to follow-up per protocol.
- Willing and able to sign informed consent.
Who cannot join
- Subject is allergic to wound care products used in this study.
- Subject has wounds with exposed blood vessels not suitable for negative pressure therapy.
- Pregnant or pregnancy-suspected subject.
- Subject actively participating in other clinical trials that conflict with the current study.
- Subject is unable or unwilling to comply with protocol requirements.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the safety and efficacy of the Closed-Incision SNaP Device.
- Conditions
- Post Surgical Wound
- Being tested
- ciSNaP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ciSNaPDevice
SNaP disposable, mechanically powered Negative Pressure Wound Therapy System
| Study group | Role | What they receive |
|---|---|---|
| ciSNaP | Experimental | Not described Receives: Device: ciSNaP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Complaints About Device Use and Operation
Frequency of complaints about device use and operation
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startNov 2010
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: The study was terminated by Spiracur. 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.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post Surgical 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- KCI USA, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01831596
- Sponsor's protocol ID
- 030110
- Status last verified
- Nov 2024
- First submitted
- 5 Apr 2013
- Last updated
- 25 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Post-Surgical Dressing
- ClinicalTrials.gov ID
- NCT01831596
- Acronym / sponsor ID
- 030110
- Conditions
- Post Surgical Wound
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated by Spiracur. Efforts were made to contact the PI/study team members, but were unsuccessful.
- Enrolment
- 59 participants (actual)
- Lead sponsor
- KCI USA, IncIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- Nov 2010 (actual)
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 15 Apr 2013 (estimated)
- Results
- Posted 28 Sep 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 safety and efficacy of the Closed-Incision SNaP Device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ciSNaP | Experimental | Device: ciSNaP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Surgically closed incision.
- Subject is 18 years of age or older.
- Subject consents to follow-up per protocol.
- Willing and able to sign informed consent.
Key exclusion criteria (5 listed)
- Subject is allergic to wound care products used in this study.
- Subject has wounds with exposed blood vessels not suitable for negative pressure therapy.
- Pregnant or pregnancy-suspected subject.
- Subject actively participating in other clinical trials that conflict with the current study.
- Subject is unable or unwilling to comply with protocol requirements.
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 |
|---|---|---|
| ciSNaPSNaP disposable, mechanically powered Negative Pressure Wound Therapy System | Device | ciSNaP |
Primary outcome
Frequency of Complaints About Device Use and Operation
Time frame: 30 days
Frequency of complaints about device use and operation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- 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?
A study testing ciSNaP in people with Post Surgical Wound, run by KCI USA, Inc 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 25 Nov 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?
Yes. Results are posted in the registry (first posted 28 Sep 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?
Frequency of Complaints About Device Use and Operation (time frame: 30 days). 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 25 Nov 2024.