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Continuous Irrigation Wound Protector for Surgical Site Infection in Colorectal Surgery

N/A
Waitlist Available
Led By Scott Steele, MD
Research Sponsored by Scott Steele
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Anticipated incision length of 3-17 cm
Clean-contaminated, contaminated and dirty wounds per the definition above
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

Study Summary

This trial found that the use of intraoperative wound irrigation in addition to barrier wound protectors significantly reduces the incidence of SSI following colorectal surgery.

Who is the study for?
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).Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not listed, potential risks may include irritation at the wound site due to continuous irrigation or allergic reactions to materials in the wound protectors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My surgery will involve a cut between 3 to 17 cm long.
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My wound is not clean and might be infected.
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I am 18 years old or older.
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My surgery will have an incision between 3 to 17 cm long.
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I am scheduled for colorectal surgery, either open or minimally invasive.
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I am receiving standard infection prevention treatment before surgery.
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I am scheduled for surgery to remove part of my colon, either open or laparoscopic.
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I am receiving standard infection prevention treatments before surgery.
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My wound is not clean and may be infected.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Surgical Site Infection rate

Trial Design

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 Location

Who is running the clinical trial?

Scott SteeleLead Sponsor
1 Previous Clinical Trials
58 Total Patients Enrolled
The Cleveland ClinicLead Sponsor
1,019 Previous Clinical Trials
1,364,310 Total Patients Enrolled
Scott Steele, MDPrincipal Investigator - The Cleveland Clinic
Cleveland Clinic Hospital
University Of Wisconsin Medical Sch (Medical School)
University Of Mn Medical Sch (Residency)

Media Library

CleanCision Wound Retraction and Protection System Clinical Trial Eligibility Overview. Trial Name: NCT03816995 — N/A
Colorectal Surgery Research Study Groups: Alexis O Wound Protector, CleanCision Wound Protector
Colorectal Surgery Clinical Trial 2023: CleanCision Wound Retraction and Protection System Highlights & Side Effects. Trial Name: NCT03816995 — N/A
CleanCision Wound Retraction and Protection System 2023 Treatment Timeline for Medical Study. Trial Name: NCT03816995 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cap on participants for this trial?

"Affirmative. By perusing information available on clinicaltrials.gov, one can deduce that enrollment for this trial is ongoing. This medical project was first made public on December 2nd 2019 and the most recent update occurred 17th February 2022, with a total of 702 patients being sought from 1 participating site."

Answered by AI

Is this experiment currently enrolling participants?

"The information posted on clinicaltrials.gov demonstrates that this research is currently recruiting participants, having first been made available to the public back in February 12th 2019 and being most recently revised on February 17 2022."

Answered by AI
Recent research and studies
~115 spots leftby Mar 2025