Colorectal Surgery, Wound Contamination
Conditions
Brief 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.
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.
Interventions
DEVICECleanCision
Wound protection during colorectal surgery.
Sponsors
Prescient Surgical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy (Enteric Bacterial Contamination on the Exposed Surface of the CleanCision Sheath Compared to the Protected Incision Edge) | 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) | 30 days | Incidence of Serious Adverse Events directly attributable to the device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy (Bacterial Contamination on the Exposed Surface of the CleanCision Sheath Compared to the Protected Incision Edge) | 1 day (end of the procedure and removal of the investigational device) | Comparison of bacterial contamination on the exposed surface of the CleanCision sheath compared to the protected incision edge |
Countries
United States
Participant flow
Pre-assignment details
There were 11 subjects in an initial study phase conducted at a single-center. The protocol was modified following this phase. Also, 11 subjects were in a pre-specified roll-in phase. The 22 participants in the Initial Study Phase and Roll-In Phase account for the discrepancy between Protocol Enrollment and Participant Flow Started value.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm All study subjects will be treated using the CleanCision device. | 86 |
| Total | 86 |
Baseline characteristics
| Characteristic | Treatment Arm |
|---|---|
| Age, Continuous | 62.4 years STANDARD_DEVIATION 13.2 |
| BMI | 29.0 kg/m^2 STANDARD_DEVIATION 5.8 |
| Medical History Colorectal Cancer | 33 Participants |
| Medical History Diabetes | 19 Participants |
| Medical History History of Smoking | 46 Participants |
| Medical History Hypertension | 46 Participants |
| Medical History IBD | 14 Participants |
| Medical History Steroid or other immunosuppressant within 1 month | 30 Participants |
| Race/Ethnicity, Customized Black or African American | 4 participants |
| Race/Ethnicity, Customized Other | 1 participants |
| Race/Ethnicity, Customized White | 81 participants |
| Region of Enrollment United States | 86 participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 86 |
| other Total, other adverse events | 10 / 86 |
| serious Total, serious adverse events | 17 / 86 |
Outcome results
Primary
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
Time frame: 1 day (end of the procedure and removal of the investigational device)
Population: Two subjects did not have swab results and thus were not included in the intention-to-treat analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Arm | Efficacy (Enteric Bacterial Contamination on the Exposed Surface of the CleanCision Sheath Compared to the Protected Incision Edge) | Contamination Rate on Exposed Surface | 33.3 % of participants with contamination |
| Treatment Arm | Efficacy (Enteric Bacterial Contamination on the Exposed Surface of the CleanCision Sheath Compared to the Protected Incision Edge) | Contamination Rate on Protected Incision Edge | 9.5 % of participants with contamination |
p-value: <0.001McNemar
Primary
Safety (Serious Adverse Events Directly Attributable to the Device)
Incidence of Serious Adverse Events directly attributable to the device
Time frame: 30 days
Population: All subjects within the Treatment arm were analyzed (Intention-to-treat).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Arm | Safety (Serious Adverse Events Directly Attributable to the Device) | 0 Participants |
Secondary
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
Time frame: 1 day (end of the procedure and removal of the investigational device)
Population: Two subjects did not have swab results and thus were not included in the intention-to-treat analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Arm | Efficacy (Bacterial Contamination on the Exposed Surface of the CleanCision Sheath Compared to the Protected Incision Edge) | Contamination Rate on Exposed Surface | 34.5 % of participants with contamination |
| Treatment Arm | Efficacy (Bacterial Contamination on the Exposed Surface of the CleanCision Sheath Compared to the Protected Incision Edge) | Contamination Rate on Protected Incision Edge | 11.9 % of participants with contamination |
p-value: <0.001McNemar