702 Participants Needed

Continuous Irrigation Wound Protector for Surgical Site Infection in Colorectal Surgery

Recruiting at 1 trial location
AO
HR
Overseen ByHolly Renner
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Scott Steele
Must be taking: Prophylactic antibiotics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

SS

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

My wound is not clean and might be infected.
My surgery will have an incision between 3 to 17 cm long.
I am scheduled for colorectal surgery, either open or minimally invasive.
See 4 more

Exclusion Criteria

I need surgery urgently due to my condition.
I haven't taken antibiotics for an infection in the week before surgery, except for prevention.
I had major abdominal surgery within the last 15 days.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo colorectal surgery using either the Alexis O wound protector or the CleanCision wound retraction and protection system

1 day
1 visit (in-person)

Follow-up

Participants are monitored for surgical site infections post-operatively

30 days
Follow-up visits as needed

Treatment Details

Interventions

  • Alexis O Wound Protector
  • CleanCision Wound Retraction and Protection System
Trial Overview The study tests two methods to prevent surgical site infections during colorectal surgeries: the Alexis O Wound Protector and the CleanCision system. Both aim to reduce wound contamination by providing barrier protection and continuous irrigation.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: CleanCision Wound ProtectorExperimental Treatment1 Intervention
Participants will undergo standard surgical procedure using the CleanCision Wound Retraction and Protection System
Group II: Alexis O Wound ProtectorActive Control1 Intervention
Participants will undergo standard surgical procedure using the Alexis O wound protector.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Scott Steele

Lead Sponsor

Trials
2
Recruited
760+

The Cleveland Clinic

Lead Sponsor

Trials
1,072
Recruited
1,377,000+

References

Randomized, controlled investigation of the anti-infective properties of the Alexis retractor/protector of incision sites. [2007]
Usefulness of a circumferential wound retractor in emergency colorectal surgery as a preventive measure for surgical site infection. Alexis O-Ring® and emergency surgery. [2021]
ALEXIS O-Ring wound retractor vs conventional wound protection for the prevention of surgical site infections in colorectal resections(1). [2014]
Impact of wound edge protection devices on surgical site infection after laparotomy: multicentre randomised controlled trial (ROSSINI Trial). [2022]
Novel antibiotic irrigation device versus standard O-ring wound retractor in the prevention of surgical site infection following colorectal resection. [2023]
Another string.... but no bow. [2011]
Reduced wound infection in colorectal resection by using a wound auto-retractor. [2019]
Alexis Retractor: Institutional Experience of Its Applications in Head and Neck Surgery and Review of the Literature. [2022]
Plastic wound protectors do not affect wound infection rates following laparoscopic-assisted colectomy. [2019]
Role of single or double ringed circumferential wound protectors in reducing surgical site infections following colorectal resections. A systematic review. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Plastic wound protectors decreased surgical site infections following laparoscopic-assisted colectomy for colorectal cancer: A retrospective cohort study. [2021]
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