An interventional study of CleanCision in Wound Contamination and Colorectal Surgery, sponsored by Prescient Surgical. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-27.
Sponsored by Prescient Surgical · Not applicable, Interventional, and Prevention
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.
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.
This is the only study on the registry with Prescient Surgical as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All study subjects will be treated using the CleanCision device.
Device: CleanCision
Wound protection during colorectal surgery.
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)
Safety (Serious Adverse Events Directly Attributable to the Device)
Incidence of Serious Adverse Events directly attributable to the device
Time frame: 30 days
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)
| Milestone | Treatment Group |
|---|---|
| Started | 86 |
| Completed | 86 |
| Not completed | 0 |
Comparison of enteric bacterial contamination on the exposed surface of the CleanCision sheath compared to the protected incision edge
| % of participants with contamination | Treatment Arm |
|---|---|
| Contamination Rate on Exposed Surface | 33.3 |
| Contamination Rate on Protected Incision Edge | 9.5 |
Incidence of Serious Adverse Events directly attributable to the device
| Participants | Treatment Arm |
|---|---|
| Safety (Serious Adverse Events Directly Attributable to the Device) | 0 |
Comparison of bacterial contamination on the exposed surface of the CleanCision sheath compared to the protected incision edge
| % of participants with contamination | Treatment Arm |
|---|---|
| Contamination Rate on Exposed Surface | 34.5 |
| Contamination Rate on Protected Incision Edge | 11.9 |
Collected over 30 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Arm | 0/86 (0%) | 17/86 (19.8%) | 10/86 (11.6%) |
| Event | Treatment Arm |
|---|---|
| IleusGastrointestinal disorders | 3/86 |
| Myocardial infarctionCardiac disorders | 2/86 |
| InfectionInfections and infestations | 2/86 |
| AnaemiaBlood and lymphatic system disorders | 1/86 |
| Abdominal painGastrointestinal disorders | 1/86 |
| Intestinal obstructionGastrointestinal disorders | 1/86 |
| Mesenteric vein thrombosisGastrointestinal disorders | 1/86 |
| VomitingGastrointestinal disorders | 1/86 |
| PainGeneral disorders | 1/86 |
| ExcoriationInjury, poisoning and procedural complications | 1/86 |
| Event | Treatment Arm |
|---|---|
| VomitingGastrointestinal disorders | 5/86 |
| Urinary tract infectionInfections and infestations | 5/86 |
| Age, Continuous(years) | Treatment Arm |
|---|---|
| Mean | 62.4 ± 13.2 |
| Sex: Female, Male(Participants) | Treatment Arm |
|---|---|
| Female | 50 |
| Male | 36 |
| Race/Ethnicity, Customized(participants) | Treatment Arm |
|---|---|
| Black or African American | 4 |
| White | 81 |
| Other | 1 |
| Region of Enrollment(participants) | Treatment Arm |
|---|---|
| United States | 86 |
| BMI(kg/m^2) | Treatment Arm |
|---|---|
| Mean | 29.0 ± 5.8 |
| Medical History(Participants) | Treatment Arm |
|---|---|
| IBD | 14 |
| Colorectal Cancer | 33 |
| Hypertension | 46 |
| Diabetes | 19 |
| History of Smoking | 46 |
| Steroid or other immunosuppressant within 1 month | 30 |
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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