NCT03816995

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
702

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed
18 days until next milestone

Study Start

First participant enrolled

February 12, 2019

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2023

Completed
2 years until next milestone

Results Posted

Study results publicly available

August 6, 2025

Completed
Last Updated

August 6, 2025

Status Verified

July 1, 2025

Enrollment Period

4.5 years

First QC Date

January 23, 2019

Results QC Date

July 21, 2025

Last Update Submit

July 21, 2025

Conditions

Colorectal Surgery

Keywords

wound irrigationcleancisioncolorectal surgery

Outcome Measures

Primary Outcomes (1)

  • 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.

    30 days

Study Arms (2)

Alexis O Wound Protector

ACTIVE COMPARATOR

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

Device: Alexis O Wound Protector

CleanCision Wound Protector

EXPERIMENTAL

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

Device: CleanCision Wound Retraction and Protection System

Interventions

CleanCision Wound Retraction and Protection SystemDEVICE

wound retraction and irrigation

CleanCision Wound Protector
Alexis O Wound ProtectorDEVICE

wound retraction

Alexis O Wound Protector

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 18 years old and above.
  • Elective colorectal surgery with a planned resection including open or laparoscopic surgeries.
  • Clean -contaminated, contaminated and dirty wounds per the definition above.
  • Patients undergoing Standard of care SSI reduction bundle including Prophylactic AB and mechanical bowel preparation.
  • Anticipated incision length of 3-17 cm

You may not qualify if:

  • Patients younger than 18 years old.
  • Patients with a preexisting stoma.
  • Patients with prior laparotomy within 15 days.
  • Patients with an active infection or systemic antibiotic therapy within 1 week prior to surgery with the exception of preoperative antimicrobial prophylaxis.
  • Emergent/ urgent surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

Location

Related Publications (15)

  • Walz JM, Paterson CA, Seligowski JM, Heard SO. Surgical site infection following bowel surgery: a retrospective analysis of 1446 patients. Arch Surg. 2006 Oct;141(10):1014-8; discussion 1018. doi: 10.1001/archsurg.141.10.1014.

    PMID: 17043280BACKGROUND

  • Smith RL, Bohl JK, McElearney ST, Friel CM, Barclay MM, Sawyer RG, Foley EF. Wound infection after elective colorectal resection. Ann Surg. 2004 May;239(5):599-605; discussion 605-7. doi: 10.1097/01.sla.0000124292.21605.99.

    PMID: 15082963BACKGROUND

  • Konishi T, Watanabe T, Kishimoto J, Nagawa H. Elective colon and rectal surgery differ in risk factors for wound infection: results of prospective surveillance. Ann Surg. 2006 Nov;244(5):758-63. doi: 10.1097/01.sla.0000219017.78611.49.

    PMID: 17060769BACKGROUND

  • de Oliveira AC, Ciosak SI, Ferraz EM, Grinbaum RS. Surgical site infection in patients submitted to digestive surgery: risk prediction and the NNIS risk index. Am J Infect Control. 2006 May;34(4):201-7. doi: 10.1016/j.ajic.2005.12.011.

    PMID: 16679177BACKGROUND

  • Fujii S, Tsukamoto M, Fukushima Y, Shimada R, Okamoto K, Tsuchiya T, Nozawa K, Matsuda K, Hashiguchi Y. Systematic review of laparoscopic vs open surgery for colorectal cancer in elderly patients. World J Gastrointest Oncol. 2016 Jul 15;8(7):573-82. doi: 10.4251/wjgo.v8.i7.573.

    PMID: 27559437BACKGROUND

  • Serra-Aracil X, Garcia-Domingo MI, Pares D, Espin-Basany E, Biondo S, Guirao X, Orrego C, Sitges-Serra A. Surgical site infection in elective operations for colorectal cancer after the application of preventive measures. Arch Surg. 2011 May;146(5):606-12. doi: 10.1001/archsurg.2011.90.

    PMID: 21576613BACKGROUND

  • de Lissovoy G, Fraeman K, Hutchins V, Murphy D, Song D, Vaughn BB. Surgical site infection: incidence and impact on hospital utilization and treatment costs. Am J Infect Control. 2009 Jun;37(5):387-397. doi: 10.1016/j.ajic.2008.12.010. Epub 2009 Apr 23.

    PMID: 19398246BACKGROUND

  • Tanner J, Khan D, Aplin C, Ball J, Thomas M, Bankart J. Post-discharge surveillance to identify colorectal surgical site infection rates and related costs. J Hosp Infect. 2009 Jul;72(3):243-50. doi: 10.1016/j.jhin.2009.03.021. Epub 2009 May 15.

    PMID: 19446918BACKGROUND

  • Wick EC, Vogel JD, Church JM, Remzi F, Fazio VW. Surgical site infections in a "high outlier" institution: are colorectal surgeons to blame? Dis Colon Rectum. 2009 Mar;52(3):374-9. doi: 10.1007/DCR.0b013e31819a5e45.

    PMID: 19333034BACKGROUND

  • Gorgun E, Rencuzogullari A, Ozben V, Stocchi L, Fraser T, Benlice C, Hull T. An Effective Bundled Approach Reduces Surgical Site Infections in a High-Outlier Colorectal Unit. Dis Colon Rectum. 2018 Jan;61(1):89-98. doi: 10.1097/DCR.0000000000000929.

    PMID: 29215475BACKGROUND

  • Sajid MS, Rathore MA, Sains P, Singh KK. A systematic review of clinical effectiveness of wound edge protector devices in reducing surgical site infections in patients undergoing abdominal surgery. Updates Surg. 2017 Mar;69(1):21-28. doi: 10.1007/s13304-017-0415-2. Epub 2017 Jan 25.

    PMID: 28124278BACKGROUND

  • Ruiz-Tovar J, Santos J, Arroyo A, Llavero C, Armananzas L, Lopez-Delgado A, Frangi A, Alcaide MJ, Candela F, Calpena R. Effect of peritoneal lavage with clindamycin-gentamicin solution on infections after elective colorectal cancer surgery. J Am Coll Surg. 2012 Feb;214(2):202-7. doi: 10.1016/j.jamcollsurg.2011.10.014.

    PMID: 22265220BACKGROUND

  • Mueller TC, Loos M, Haller B, Mihaljevic AL, Nitsche U, Wilhelm D, Friess H, Kleeff J, Bader FG. Intra-operative wound irrigation to reduce surgical site infections after abdominal surgery: a systematic review and meta-analysis. Langenbecks Arch Surg. 2015 Feb;400(2):167-81. doi: 10.1007/s00423-015-1279-x. Epub 2015 Feb 14.

    PMID: 25681239BACKGROUND

  • Solomkin J, Gastmeier P, Bischoff P, Latif A, Berenholtz S, Egger M, Allegranzi B. WHO Guidelines to prevent surgical site infections-Authors' reply. Lancet Infect Dis. 2017 Mar;17(3):262-264. doi: 10.1016/S1473-3099(17)30081-6. Epub 2017 Feb 23. No abstract available.

    PMID: 28244389BACKGROUND

  • Papaconstantinou HT, Ricciardi R, Margolin DA, Bergamaschi R, Moesinger RC, Lichliter WE, Birnbaum EH. A Novel Wound Retractor Combining Continuous Irrigation and Barrier Protection Reduces Incisional Contamination in Colorectal Surgery. World J Surg. 2018 Sep;42(9):3000-3007. doi: 10.1007/s00268-018-4568-z.

    PMID: 29523908BACKGROUND

Results Point of Contact

Title
Rita Brienza
Organization
The Cleveland Clinic
brienzr@ccf.org
216-399-9186

Study Officials

  • Scott Steele, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
President, Main Campus Submarket

Study Record Dates

First Submitted

January 23, 2019

First Posted

January 25, 2019

Study Start

February 12, 2019

Primary Completion

August 18, 2023

Study Completion

August 18, 2023

Last Updated

August 6, 2025

Results First Posted

August 6, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)