Comparison of Surgical Glove Contamination During Total Knee Arthroplasty Procedure : a Randomized Controlled Trial

NCT ID: NCT04308798

Last Updated: 2020-03-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-31
• Study Completion Date: 2020-12-31

Brief Summary

Total knee arthroplasty post-op surgical site infection rate about 0.5- 5% Pre-operative , perioperative and post-operative prevention are importance for reduce surgical site infection The prevention of surgical-site infections (SSIs) is an integral component of nosocomial infection control and a major priority in orthopedic surgery.

Surgical wound contamination must be prevented to avoid patient colonisation by microorganisms during surgery.

Surgical glove changing perioperative can reduce contamination and perforation rate Orthopedic surgery had found contamination rate about 20-28 % Joint replacement procedure found contamination rate about 38-67% of all orthopedic surgery 12% of gloves are contaminated after draping and 24% once patient installation is complete.

We hypothesis that changing surgical glove during total knee arthroplasty can reduce contamination rate on surgical glove.

Detailed Description

Total knee arthroplasty post-op surgical site infection rate about 0.5- 5% Pre-operative , perioperative and post-operative prevention are importance for reduce surgical site infection The prevention of surgical-site infections (SSIs) is an integral component of nosocomial infection control and a major priority in orthopedic surgery.

Surgical wound contamination must be prevented to avoid patient colonisation by microorganisms during surgery.

Surgical glove changing perioperative can reduce contamination and perforation rate Orthopedic surgery had found contamination rate about 20-28 % Joint replacement procedure found contamination rate about 38-67% of all orthopedic surgery 12% of gloves are contaminated after draping and 24% once patient installation is complete.

Research question : Does changing surgical glove during total knee arthroplasty can reduce contamination rate on surgical glove?

Population : Patient who schedule for primary total knee arthroplasty in Srinagarind hospital

Inclusion criteria :Patient who schedule for primary total knee arthroplasty in Srinagarind hospital

Exclusion criteria :

Patient factor Patient who had previous open knee surgery Patient who have remote infection at period of surgery for total knee arthroplasty Patient who have lower extremity infection same side at total knee arthroplasty prior 48 hrs Surgical glove factor gross perforation Glove changing not include in criteria for study group

Primary outcome :

-Comparison contamination rate of surgical glove in treatment group and control group

Secondary outcome :

-Contamination rate in draping method period and surgical procedure prior to cementation period in total knee arthroplasty

Study design: a randomized controlled trial

Treatment group glove changing after draping and before cementation glove changing before cementation Control group

-no glove change

Pre-operative protocal

• iv. Cefazolin 1 hour prior to incision
• skin preparation by Betadine scrub
• Draping including entire limb from thigh to foot
• pre-operative hand wash by Betadine scrub for at least 2 minutes Perioperative protocal
• Operating room include horizontal laminar flow
• Use Ansell GAMMEX latex powdered surgical glove for all glove include in this study Post-operative protocal
• antibiotic prophylaxis for 24 hours post-op

The five fingertips of each hand were placed on blood agar immediately before each set of gloves were removed Culture plates were subsequently incubated at 37°C for 48 hours. A single microbiologist reported the results of the culture. The number of colonies counted as the number of colony-forming units (CFU) per dish and types of organisms were recorded

identified all bacterial isolates by using Gram stain coagulase oxidase catalase tests. The degree of contamination was divided into three grades

1. no contamination if there was no growth

2. low contamination where between one and five colonies

3. heavily contaminated if there were more than five colonies

Conditions

Surgical Glove; Total Knee Arthroplasty; Contamination Rate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control group

No surgical glove changing during total knee arthroplasty procedure

Group Type: EXPERIMENTAL

Surgical glove changing

Intervention Type: PROCEDURE

Changing surgical glove after draping and before cementation during total knee arthroplasty

Treatment 1 group

Changing surgical glove after draping and before cementation during total knee arthroplasty procedure

Group Type: EXPERIMENTAL

Surgical glove changing

Intervention Type: PROCEDURE

Changing surgical glove after draping and before cementation during total knee arthroplasty

Treatment 2 group

Changing surgical glove before cementation during total knee arthroplasty procedure

Group Type: EXPERIMENTAL

Surgical glove changing

Intervention Type: PROCEDURE

Changing surgical glove after draping and before cementation during total knee arthroplasty

Interventions

Surgical glove changing

Changing surgical glove after draping and before cementation during total knee arthroplasty

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patient who schedule for primary total knee arthroplasty

Exclusion Criteria

• Patient who had previous history of open knee surgery Patient who have remote infection during period of total knee arthroplasty Patient who have infection around lower extremity at the same site of total knee arthroplasty

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Khon Kaen University

OTHER

Sponsor Role: lead

Responsible Party

Weerachai Kosuwon

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Navapong Thitiworakarn, Doctor

Role: PRINCIPAL_INVESTIGATOR

Orthopaedic Department, Faculty of Medicine, Khon Kaen University

Locations

Orthopaedic Department, Faculty of Medicine, Khon Kaen University

Muang Khonkaen, Changwat Khon Kaen, Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

Kamolsak sukontaman, Doctor

Role: CONTACT

kamolsu@kku.ac.th

0816557443

Weerachai Kowsuwon, Professor

Role: CONTACT

weera_ko@kku.ac.th

0812625055

Facility Contacts

Navapong Thitiworakarn, Doctor

Role: primary

kaowmed38@gmail.com

66885715543

Kamolsak sukontaman, Doctor

Role: backup

kamolsu@kku.ac.th

66816557443

Other Identifiers

HE611285

Identifier Type: -

Identifier Source: org_study_id