NCT03816995

Prospective, Randomized, Parallel-arm Clinical Trial of CleanCision or Alexis O in Elective Colorectal Surgery

A Novel Wound Retractor Combining Continuous Irrigation and Barrier Protection Reduces Incisional Contamination and Surgical Site Infection in Colorectal Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 702 (actual)
• Sponsor: Scott Steele · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Surgical site infection (SSI) remains a persistent and morbid problem in colorectal surgery with published rates ranging from 7 to 25%. The negative outcomes of SSI are well reported and include a significant increase in morbidity, length of hospital stay, readmissions and healthcare-associated cost. Therefore, 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. Key to the pathogenesis of SSI is the degree of bacterial contamination of the surgical wound. Preventing contamination of the wound or reducing the bacterial load through the use of barrier wound protectors or intraoperative wound irrigation has shown significant promise individually and is an ongoing strategic focus to reduce wound infections after surgery. The usage of intraoperative wound irrigation has been shown to significantly reduce the risk of SSI via multiple RTC. A surgical device that combines continuous wound irrigation and barrier protection will have an important SSI prevention advantage. CleanCision is a recently developed apparatus that serves this purpose and was found to reduce bacterial wound contamination in preclinical and clinical trials. This study aims to investigate the effect of using CleanCision wound protector on the rates of postoperative Surgical Site Infections in comparison to the current wound protector (Alexis O) being used at our institute.

Conditions

• Colorectal Surgery

Interventions

Type	Name	Description
DEVICE	CleanCision Wound Retraction and Protection System	wound retraction and irrigation
DEVICE	Alexis O Wound Protector	wound retraction

Timeline

• Start date: 2019-02-12
• Primary completion: 2023-08-18
• Completion: 2023-08-18
• First posted: 2019-01-25
• Last updated: 2025-08-06
• Results posted: 2025-08-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study