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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | All study subjects will be treated using the CleanCision device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CleanCision | Device | Wound protection during colorectal surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 day (end of the procedure and removal of the investigational device) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harry Papaconstantinou, MD | Scott & White Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States | ||
| Lahey Hospital and Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29523908 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | All study subjects were treated using the CleanCision device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm | All study subjects will be treated using the CleanCision device. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Two subjects did not have swab results and thus were not included in the intention-to-treat analysis. | Posted | Number | % of participants with contamination | 1 day (end of the procedure and removal of the investigational device) |
|
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Arm | All study subjects will be treated using the CleanCision device. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical | Prescient Surgical | 6504895025 | lclaude@prescientsurgical.com |
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| Burlington |
| Massachusetts |
| 01805 |
| United States |
| Washington University Medical Center | St Louis | Missouri | 63110 | United States |
| Stony Brook Medicine | Stony Brook | New York | 11794 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| Scott & White Memorial Hospital | Temple | Texas | 76508 | United States |
| Intermountain Healthcare McKay-Dee Hospital | Ogden | Utah | 84403 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Medical History | Count of Participants | Participants |
|
| Participants |
|
|
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| Primary | Safety (Serious Adverse Events Directly Attributable to the Device) | Incidence of Serious Adverse Events directly attributable to the device | All subjects within the Treatment arm were analyzed (Intention-to-treat). | Posted | Count of Participants | Participants | 30 days |
|
|
|
| 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 | Two subjects did not have swab results and thus were not included in the intention-to-treat analysis. | Posted | Number | % of participants with contamination | 1 day (end of the procedure and removal of the investigational device) |
|
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| 0 |
| 86 |
| 17 |
| 86 |
| 10 |
| 86 |
| Myocardial infarction | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Mesenteric vein thrombosis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Gastrointestinal anastomotic leak | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Hypovolaemic shock | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Intra-abdominal haematoma | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
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