Wound ContaminationCIRCENCT02413879
Cleancision IntRaoperative Contamination prEvention Study
A study testing CleanCision in people with Wound Contamination and Colorectal Surgery, run by Prescient Surgical at 7 sites in United States.
Trial summary
This study entitled, An Evaluation of the Safety and Efficacy of the CleanCision Wound Retraction and Protection System in Protecting Surgical Incisions from Intraoperative Contamination When Used during Colorectal Surgery, is designed to evaluate contamination at the wound incision site when the CleanCision is used… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Contamination, Colorectal Surgery
- What is being tested?
- CleanCision
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 7 sitesUnited States
- Study dates
- Mar 2015to Jul 2016
- 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
- Age 18 and older
- BMI 15-45, inclusive
- Colorectal surgery patient, planned resection
- Incision length meets labeling requirements
- Written informed consent using the governing IRB approved form
Who cannot join
- Patients with a pre-existing stoma
- Patients undergoing emergent colorectal surgery
- Known history of contact hypersensitivity or allergy to device materials
- Prior laparotomy or abdominal surgery within a timeframe that may present a safety risk or compromise study results
- Active infection, sepsis or systemic antibiotic therapy within timeframe that may impact safety or study results
- Active participation in any other clinical study of an experimental drug or device that may impact safety or study results
Show all 10Show fewer
- Postsurgical life expectancy is less than the study follow up period
- Subject is pregnant or lactating
- Subject is under incarceration
- Subject considered to be inoperable following exploratory surgery
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
Baylor University Medical Center
Dallas, Texas, 75246
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Intermountain Healthcare McKay-Dee Hospital
Ogden, Utah, 84403
Washington University Medical Center
St Louis, Missouri, 63110
Stony Brook Medicine
Stony Brook, New York, 11794
Scott & White Memorial Hospital
Temple, Texas, 76508
About this study
Official title: An Evaluation of the Safety and Efficacy of the CleanCision Wound Retraction and Protection System in Protecting Surgical Incisions From Intraoperative Contamination When Used During Colorectal Surgery
This study entitled, An Evaluation of the Safety and Efficacy of the CleanCision Wound Retraction and Protection System in Protecting Surgical Incisions from Intraoperative Contamination When Used during Colorectal Surgery, is designed to evaluate contamination at the wound incision site when the CleanCision is used during surgery.
Read the detailed description
This study entitled, An Evaluation of the Safety and Efficacy of the CleanCision Wound Retraction and Protection System in Protecting Surgical Incisions from Intraoperative Contamination When Used during Colorectal Surgery, is designed to evaluate bacterial contamination at the wound incision site when the CleanCision is used during surgery. The CleanCision is a surgical tool that is designed to be used for the primary purpose of protecting the wound from contamination that occurs to the incision site during surgery ultimately reducing the occurrence of Surgical Site Infections (SSI).
This is a prospective, multi-center, single-arm (non-randomized) clinical study.
- Conditions
- Wound Contamination, Colorectal Surgery
- Being tested
- CleanCision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CleanCisionDevice
Wound protection during colorectal surgery.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | All study subjects will be treated using the CleanCision device. Receives: Device: CleanCision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy (Enteric Bacterial Contamination on the Exposed Surface of the CleanCision Sheath Compared to the Protected Incision Edge)
Comparison of enteric bacterial contamination on the exposed surface of the CleanCision sheath compared to the protected incision edge
Measured: 1 day (end of the procedure and removal of the investigational device)
Safety (Serious Adverse Events Directly Attributable to the Device)
Incidence of Serious Adverse Events directly attributable to the device
Measured: 30 days
Secondary outcomes (1)
Efficacy (Bacterial Contamination on the Exposed Surface of the CleanCision Sheath Compared to the Protected Incision Edge)
Comparison of bacterial contamination on the exposed surface of the CleanCision sheath compared to the protected incision edge
Measured: 1 day (end of the procedure and removal of the investigational device)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2016
- Study completionJul 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wound ContaminationStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prescient Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Harry Papaconstantinou, MD, Principal investigator, Scott & White Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413879
- Sponsor's protocol ID
- CLP-0001
- Acronym
- CIRCE
- Status last verified
- Jul 2017
- First submitted
- 27 Mar 2015
- Last updated
- 27 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Papaconstantinou HT, Ricciardi R, Margolin DA, Bergamaschi R, Moesinger RC, Lichliter WE, Birnbaum EH. A Novel Wound Retractor Combining Continuous Irrigation and Barrier Protection Reduces Incisional Contamination in Colorectal Surgery. World J Surg. 2018 Sep;42(9):3000-3007. doi: 10.1007/s00268-018-4568-z.
PubMed 29523908
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Safety and Efficacy of the CleanCision Wound Retraction and Protection System in Protecting Surgical Incisions From Intraoperative Contamination When Used During Colorectal Surgery
- ClinicalTrials.gov ID
- NCT02413879
- Acronym / sponsor ID
- CIRCE / CLP-0001
- Conditions
- Wound Contamination, Colorectal Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Prescient SurgicalIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 10 Apr 2015 (estimated)
- Results
- Posted 13 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study entitled, An Evaluation of the Safety and Efficacy of the CleanCision Wound Retraction and Protection System in Protecting Surgical Incisions from Intraoperative Contamination When Used during Colorectal Surgery, is designed to evaluate contamination at the wound incision site when the CleanCision is used during surgery.
Detailed description
This study entitled, An Evaluation of the Safety and Efficacy of the CleanCision Wound Retraction and Protection System in Protecting Surgical Incisions from Intraoperative Contamination When Used during Colorectal Surgery, is designed to evaluate bacterial contamination at the wound incision site when the CleanCision is used during surgery. The CleanCision is a surgical tool that is designed to be used for the primary purpose of protecting the wound from contamination that occurs to the incision site during surgery ultimately reducing the occurrence of Surgical Site Infections (SSI).
This is a prospective, multi-center, single-arm (non-randomized) clinical study.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: CleanCisionAll study subjects will be treated using the CleanCision device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 and older
- BMI 15-45, inclusive
- Colorectal surgery patient, planned resection
- Incision length meets labeling requirements
- Written informed consent using the governing IRB approved form
Key exclusion criteria (10 listed)
- Patients with a pre-existing stoma
- Patients undergoing emergent colorectal surgery
- Known history of contact hypersensitivity or allergy to device materials
- Prior laparotomy or abdominal surgery within a timeframe that may present a safety risk or compromise study results
- Active infection, sepsis or systemic antibiotic therapy within timeframe that may impact safety or study results
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 |
|---|---|---|
| CleanCisionWound protection during colorectal surgery. | Device | Treatment Group |
Primary outcome
Efficacy (Enteric Bacterial Contamination on the Exposed Surface of the CleanCision Sheath Compared to the Protected Incision Edge)
Time frame: 1 day (end of the procedure and removal of the investigational device)
Comparison of enteric bacterial contamination on the exposed surface of the CleanCision sheath compared to the protected incision edge
Safety (Serious Adverse Events Directly Attributable to the Device)
Time frame: 30 days
Incidence of Serious Adverse Events directly attributable to the device
1 secondary outcome
Efficacy (Bacterial Contamination on the Exposed Surface of the CleanCision Sheath Compared to the Protected Incision Edge)
Time frame: 1 day (end of the procedure and removal of the investigational device)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29523908Papaconstantinou HT, Ricciardi R, Margolin DA, Bergamaschi R, Moesinger RC, Lichliter WE, Birnbaum EH. A Novel Wound Retractor Combining Continuous Irrigation and Barrier Protection Reduces Incisional Contamination in Colorectal Surgery. World J Surg. 2018 Sep;42(9):3000-3007. doi: 10.1007/s00268-018-4568-z.
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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.
Harry Papaconstantinou, MD principal investigator
Scott & White Memorial Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CleanCision in people with Wound Contamination and Colorectal Surgery, run by Prescient Surgical at 7 sites 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 10 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 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 13 Jul 2017). 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?
Efficacy (Enteric Bacterial Contamination on the Exposed Surface of the CleanCision Sheath Compared to the Protected Incision Edge) (time frame: 1 day (end of the procedure and removal of the investigational device)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02413879, which also lists 1 linked publication.
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 27 Jul 2017; AzTrials last refreshed its copy on 27 Oct 2026.