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

March 12, 2020 updated by: Weerachai Kosuwon, Khon Kaen University

Comparison of Surgical Glove Contamination During Total Knee Arthroplasty Procedure

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.

Study Overview

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

Study Type

Interventional

Enrollment (Anticipated)

41

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kamolsak sukontaman, Doctor
  • Phone Number: 0816557443
  • Email: kamolsu@kku.ac.th

Study Contact Backup

Study Locations

    • Khon Kaen
      • Muang Khonkaen, Khon Kaen, Thailand, 40002
        • Recruiting
        • Orthopaedic Department, Faculty of Medicine, Khon Kaen University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Control group
No surgical glove changing during total knee arthroplasty procedure
Changing surgical glove after draping and before cementation during total knee arthroplasty
EXPERIMENTAL: Treatment 1 group
Changing surgical glove after draping and before cementation during total knee arthroplasty procedure
Changing surgical glove after draping and before cementation during total knee arthroplasty
EXPERIMENTAL: Treatment 2 group
Changing surgical glove before cementation during total knee arthroplasty procedure
Changing surgical glove after draping and before cementation during total knee arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison contamination rate on surgical glove
Time Frame: 30 months from randomization
Contamination rate on surgical glove during total knee arthroplasty
30 months from randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contamination rate on surgical glove
Time Frame: 30 months from randomization
Contamination rate on surgical glove during period after draping and before cementation
30 months from randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Navapong Thitiworakarn, Doctor, Orthopaedic Department, Faculty of Medicine, Khon Kaen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 1, 2020

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

February 25, 2020

First Submitted That Met QC Criteria

March 12, 2020

First Posted (ACTUAL)

March 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 16, 2020

Last Update Submitted That Met QC Criteria

March 12, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • HE611285

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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