Colorectal Surgery
Conditions
Keywords
wound irrigation, cleancision, colorectal surgery
Brief summary
Surgical site infection (SSI) remains a problem in colorectal surgery. Strategies to reduce the incidence of SSI following colorectal surgery are important to improve overall patient outcomes, reduce healthcare-associated costs and provide value-based healthcare to surgical patients. Preventing contamination of the wound through the use of barrier wound protectors or intraoperative wound irrigation has shown significant promise individually and is an ongoing focus to reduce wound infections SSI.
Detailed description
Surgical site infection (SSI) remains a persistent and morbid problem in colorectal surgery with published rates ranging from 7 to 25%. The negative outcomes of SSI are well reported and include a significant increase in morbidity, length of hospital stay, readmissions and healthcare-associated cost. Therefore, strategies to reduce the incidence of SSI following colorectal surgery are important to improve overall patient outcomes, reduce healthcare-associated costs and provide value-based healthcare to surgical patients. Key to the pathogenesis of SSI is the degree of bacterial contamination of the surgical wound. Preventing contamination of the wound or reducing the bacterial load through the use of barrier wound protectors or intraoperative wound irrigation has shown significant promise individually and is an ongoing strategic focus to reduce wound infections after surgery. The usage of intraoperative wound irrigation has been shown to significantly reduce the risk of SSI via multiple RTC. A surgical device that combines continuous wound irrigation and barrier protection will have an important SSI prevention advantage. CleanCision is a recently developed apparatus that serves this purpose and was found to reduce bacterial wound contamination in preclinical and clinical trials. This study aims to investigate the effect of using CleanCision wound protector on the rates of postoperative Surgical Site Infections in comparison to the current wound protector (Alexis O) being used at our institute.
Interventions
DEVICECleanCision Wound Retraction and Protection System
wound retraction and irrigation
DEVICEAlexis O Wound Protector
wound retraction
Sponsors
Prescient Surgical
Scott Steele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients 18 years old and above. 2. Elective colorectal surgery with a planned resection including open or laparoscopic surgeries. 3. Clean -contaminated, contaminated and dirty wounds per the definition above. 4. Patients undergoing Standard of care SSI reduction bundle including Prophylactic AB and mechanical bowel preparation. 5. Anticipated incision length of 3-17 cm
Exclusion criteria
1. Patients younger than 18 years old. 2. Patients with a preexisting stoma. 3. Patients with prior laparotomy within 15 days. 4. Patients with an active infection or systemic antibiotic therapy within 1 week prior to surgery with the exception of preoperative antimicrobial prophylaxis. 5. Emergent/ urgent surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Site Infection (SSI) Rate | 30 days | To evaluate the 30 day post-operative SSI rate in patients undergoing elective colorectal surgical procedures after intraoperative usage of Alexis O wound protector vs. CleanCision continuous irrigation wound protector. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Alexis O Wound Protector Participants will undergo standard surgical procedure using the Alexis O wound protector.
Alexis O Wound Protector: wound retraction | 327 |
| CleanCision Wound Protector Participants will undergo standard surgical procedure using the CleanCision Wound Retraction and Protection System
CleanCision Wound Retraction and Protection System: wound retraction and irrigation | 318 |
| Total | 645 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Cancelled Surgery | 8 | 12 |
| Overall Study | No wound protector used | 11 | 17 |
| Overall Study | Protocol Violation | 2 | 3 |
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | CleanCision Wound Protector | Total | Alexis O Wound Protector |
|---|---|---|---|
| Age, Continuous | 57.2 years STANDARD_DEVIATION 14.9 | 57.7 years STANDARD_DEVIATION 16.05 | 58.1 years STANDARD_DEVIATION 15.3 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 318 participants | 645 participants | 327 participants |
| Sex: Female, Male Female | 187 Participants | 355 Participants | 168 Participants |
| Sex: Female, Male Male | 131 Participants | 290 Participants | 159 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 327 | 0 / 318 |
| other Total, other adverse events | 98 / 327 | 95 / 318 |
| serious Total, serious adverse events | 0 / 327 | 0 / 318 |
Outcome results
Primary
Surgical Site Infection (SSI) Rate
To evaluate the 30 day post-operative SSI rate in patients undergoing elective colorectal surgical procedures after intraoperative usage of Alexis O wound protector vs. CleanCision continuous irrigation wound protector.
Time frame: 30 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alexis O Wound Protector | Surgical Site Infection (SSI) Rate | Post-op Superficial SSI | 16 Participants |
| Alexis O Wound Protector | Surgical Site Infection (SSI) Rate | Post-op Deep SSI | 6 Participants |
| Alexis O Wound Protector | Surgical Site Infection (SSI) Rate | Post-op Organ/Space SSI | 6 Participants |
| Alexis O Wound Protector | Surgical Site Infection (SSI) Rate | Composite Infection (SSIs + Wound Disruption) | 28 Participants |
| CleanCision Wound Protector | Surgical Site Infection (SSI) Rate | Composite Infection (SSIs + Wound Disruption) | 18 Participants |
| CleanCision Wound Protector | Surgical Site Infection (SSI) Rate | Post-op Superficial SSI | 14 Participants |
| CleanCision Wound Protector | Surgical Site Infection (SSI) Rate | Post-op Organ/Space SSI | 3 Participants |
| CleanCision Wound Protector | Surgical Site Infection (SSI) Rate | Post-op Deep SSI | 1 Participants |