Continuous Irrigation Wound Protector for Surgical Site Infection in Colorectal Surgery

No longer recruiting at 1 trial location

Overseen By Holly Renner

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Scott Steele

Must be taking: Prophylactic antibiotics

Must not be taking: Systemic antibiotics

Disqualifiers: Preexisting stoma, Prior laparotomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to find better ways to prevent surgical site infections (SSIs) in individuals undergoing colorectal surgery. It tests two tools: the Alexis O Wound Protector and the CleanCision Wound Retraction and Protection System, to determine which one best maintains wound cleanliness during surgery. The trial seeks participants planning to undergo elective colorectal surgery with a planned resection and an incision length of 3-17 cm. Eligible participants could help improve surgical care for future patients. As an unphased trial, this study provides a unique opportunity to contribute to advancements in surgical care without the constraints of traditional clinical trial phases.

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 prior data suggests that these wound protection systems are safe for use in colorectal surgery?

Research has shown that both the Alexis O Wound Protector and the CleanCision Wound Retraction and Protection System are safe. Previous studies have demonstrated that the Alexis O Wound Protector effectively reduces infections at the surgery site during colorectal surgeries by maintaining cleanliness. This indicates it is safe and well-tolerated.

For the CleanCision system, studies found that it significantly lowers infection rates compared to standard wound protectors. This suggests it not only helps prevent infections but is also safe, with no major side effects reported.

Both treatments aim to protect the surgery site and prevent infections, which is crucial for patient recovery. While specific side effects are not detailed in the sources, the absence of major side effects suggests these treatments are generally safe for patients undergoing colorectal surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative techniques to reduce surgical site infections in colorectal surgery. The Alexis O Wound Protector and the CleanCision Wound Retraction and Protection System offer unique methods of wound protection during surgery. The Alexis O provides a physical barrier to contaminants, while the CleanCision system actively irrigates the wound site to flush away potential pathogens. By investigating these methods, researchers aim to find more effective ways to minimize infections and improve recovery times for patients undergoing colorectal surgery.

What evidence suggests that this trial's treatments could be effective for reducing surgical site infections in colorectal surgery?

Research has shown that the CleanCision Wound Retraction and Protection System, one of the treatments in this trial, can greatly reduce the risk of infection at the surgery site after colorectal surgery. In studies, patients using this system experienced fewer infections within 30 days post-surgery. The system combines a protective barrier with a continuous cleaning process, maintaining wound cleanliness during surgery. This approach has proven to lower infection rates compared to standard methods.

The Alexis O Wound Protector, another treatment option in this trial, also prevents contamination during surgery. However, less detailed information is available comparing its effectiveness to the CleanCision system. Both tools in this trial aim to enhance patient recovery by reducing infection risk. ^{1 2 6 7 8}

Who Is on the Research Team?

Scott Steele, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: CleanCision Wound Protector Experimental Treatment 1 Intervention

Participants will undergo standard surgical procedure using the CleanCision Wound Retraction and Protection System

Group II: Alexis O Wound Protector Active Control 1 Intervention

Participants will undergo standard surgical procedure using the Alexis O wound protector.

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+

Prescient Surgical

Industry Sponsor

Trials

1

Recruited

110+

Citations

1. journalofsurgicalresearch.com journalofsurgicalresearch.com/article/S0022-4804(21)00180-3/fulltext

Initial Outcomes of a Novel Irrigating Wound Protector for ... We aimed to evaluate 30-day SSI outcomes of a novel wound retractor that combines barrier protection with continuous wound irrigation in elective colorectal ...

2. journals.lww.com journals.lww.com/journalacs/fulltext/2022/11002/novel_cleancision_irrigating_wound_retractor_vs.22.aspx

Novel CleanCision Irrigating Wound Retractor vs Standard... We sought to compare the effectiveness of both retractors in preventing SSIs after colorectal resections. Methods: This single-arm clinical trial included ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022480421001803

Initial Outcomes of a Novel Irrigating Wound Protector for ... We aimed to evaluate 30-day SSI outcomes of a novel wound retractor that combines barrier protection with continuous wound irrigation in elective colorectal ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9293099/

Reducing surgical site infection rates in colorectal surgery A successful reduction in the rate of SSI following elective colorectal surgery can be achieved by adopting a comprehensive perioperative bundle.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8719508/

Delphi Consensus on Intraoperative Technical/Surgical ... Colorectal surgery (CRS) is associated with one of the highest surgical site infection (SSI) rates after surgical procedures of all types, with ...

6. biospace.com biospace.com/cleancision-shown-to-significantly-reduce-high-surgical-site-infection-rates-in-colorectal-surgery-as-compared-to-standard-wound-protectors

CleanCision Shown to Significantly Reduce High Surgical ... The study evaluated 30-day SSI outcomes for CleanCision, the novel wound retraction device that combines barrier protection and continuous ...

7. withpower.com withpower.com/trial/phase-surgical-wound-infection-1-2019-6c0af

Continuous Irrigation Wound Protector for Surgical Site ... Research shows that the Alexis O-Ring wound retractor is effective in preventing surgical site infections (SSIs) in colorectal surgery by reducing contamination ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11278392/

Surgical Site Infections in Colorectal Cancer Surgeries One study found that meticulous wound management during surgery can significantly reduce the risk of incisional SSIs in elective colorectal cancer surgeries [31] ...