N/A
N=86
Cleancision IntRaoperative Contamination prEvention Study
Wound Contamination · Colorectal Surgery
Bottom Line
View on ClinicalTrials.gov: NCT02413879 ↗Enrolled (actual)
86
Serious AEs
19.8%
Results posted
Jul 2017
Primary outcome: Primary: Efficacy (Enteric Bacterial Contamination on the Exposed Surface of the CleanCision Sheath Compared to the Protected Incision Edge) — 33.3; 9.5 % of participants with contamination — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CleanCision (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Prescient Surgical
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy (Enteric Bacterial Contamination on the Exposed Surface of the CleanCision Sheath Compared to the Protected Incision Edge) |
33.3; 9.5 | <0.001 sig |
| PRIMARY Safety (Serious Adverse Events Directly Attributable to the Device) |
— | — |
| SECONDARY Efficacy (Bacterial Contamination on the Exposed Surface of the CleanCision Sheath Compared to the Protected Incision Edge) |
34.5; 11.9 | <0.001 sig |
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 during surgery.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT02413879). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.