Continuous Irrigation Wound Protector for Surgical Site Infection in Colorectal Surgery
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on systemic antibiotic therapy, you must not have taken it within one week before the surgery, except for preoperative antimicrobial prophylaxis.
What data supports the effectiveness of the treatment Alexis O Wound Protector, CleanCision Wound Retraction and Protection System for preventing surgical site infections in colorectal surgery?
Research shows that the Alexis O-Ring wound retractor is effective in preventing surgical site infections (SSIs) in colorectal surgery by reducing contamination and mechanical trauma during surgery. Studies have demonstrated its usefulness in both emergency and planned colorectal surgeries, suggesting it may be superior to conventional methods in reducing SSIs.12345
Is the Continuous Irrigation Wound Protector safe for use in surgeries?
The Alexis Wound Retractor, also known as the Continuous Irrigation Wound Protector, has been used in various surgeries, including colorectal and hip surgeries, without reports of harm to patients. Studies suggest it may reduce the risk of wound infections, indicating it is generally safe for use in humans.13678
How does the Continuous Irrigation Wound Protector treatment differ from other treatments for preventing surgical site infections in colorectal surgery?
The Continuous Irrigation Wound Protector is unique because it combines the use of a wound protector with continuous irrigation (steady flow of fluid) to potentially reduce surgical site infections. This approach may offer additional protection against infections compared to standard wound protectors, which do not include continuous irrigation.1291011
What is the purpose of this trial?
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.
Research Team
Scott Steele, MD
Principal Investigator
The Cleveland Clinic
Eligibility Criteria
This trial is for adults over 18 undergoing elective colorectal surgery, with wounds classified as clean-contaminated to dirty. They must be part of a standard infection prevention protocol and have an incision length between 3-17 cm. It's not for those under 18, with preexisting stomas, recent laparotomy, active infections or on systemic antibiotics (except for preoperative prophylaxis).Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo colorectal surgery using either the Alexis O wound protector or the CleanCision wound retraction and protection system
Follow-up
Participants are monitored for surgical site infections post-operatively
Treatment Details
Interventions
- Alexis O Wound Protector
- CleanCision Wound Retraction and Protection System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Scott Steele
Lead Sponsor
The Cleveland Clinic
Lead Sponsor