- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04308798
Comparison of Surgical Glove Contamination During Total Knee Arthroplasty Procedure : a Randomized Controlled Trial
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
Status
Intervention / Treatment
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
- no contamination if there was no growth
- low contamination where between one and five colonies
- heavily contaminated if there were more than five colonies
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Kamolsak sukontaman, Doctor
- Phone Number: 0816557443
- Email: kamolsu@kku.ac.th
Study Contact Backup
- Name: Weerachai Kowsuwon, Professor
- Phone Number: 0812625055
- Email: weera_ko@kku.ac.th
Study Locations
-
-
Khon Kaen
-
Muang Khonkaen, Khon Kaen, Thailand, 40002
- Recruiting
- Orthopaedic Department, Faculty of Medicine, Khon Kaen University
-
Contact:
- Navapong Thitiworakarn, Doctor
- Phone Number: 66885715543
- Email: kaowmed38@gmail.com
-
Contact:
- Kamolsak sukontaman, Doctor
- Phone Number: 66816557443
- Email: kamolsu@kku.ac.th
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Navapong Thitiworakarn, Doctor, Orthopaedic Department, Faculty of Medicine, Khon Kaen University
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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