Surgical GlovePhase 3NCT04308798
Comparison of Surgical Glove Contamination During Total Knee Arthroplasty Procedure : a Randomized Controlled Trial
A Phase 3 study testing Surgical glove changing in people with Surgical Glove and Total Knee Arthroplasty, run by Khon Kaen University at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Surgical Glove, Total Knee Arthroplasty, Contamination Rate
- What is being tested?
- Surgical glove changing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2020to Dec 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patient who schedule for primary total knee arthroplasty
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Orthopaedic Department, Faculty of Medicine, Khon Kaen University
Muang Khonkaen, Changwat Khon Kaen, 40002
Navapong Thitiworakarn, Doctor, 66885715543, kaowmed38@gmail.com
Kamolsak sukontaman, Doctor, 66816557443, kamolsu@kku.ac.th
About this study
Official title: 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.
Read more
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.
Read the 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
- Conditions
- Surgical Glove, Total Knee Arthroplasty, Contamination Rate
- Being tested
- Surgical glove changing
- Keywords
- Total knee arthroplasty, Surgical glove, Contamination rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical glove changingProcedure or surgery
Changing surgical glove after draping and before cementation during total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | No surgical glove changing during total knee arthroplasty procedure Receives: Procedure: Surgical glove changing |
| Treatment 1 group | Experimental | Changing surgical glove after draping and before cementation during total knee arthroplasty procedure Receives: Procedure: Surgical glove changing |
| Treatment 2 group | Experimental | Changing surgical glove before cementation during total knee arthroplasty procedure Receives: Procedure: Surgical glove changing |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison contamination rate on surgical glove
Contamination rate on surgical glove during total knee arthroplasty
Measured: 30 months from randomization
Secondary outcomes (1)
Contamination rate on surgical glove
Contamination rate on surgical glove during period after draping and before cementation
Measured: 30 months from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study startJul 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical GloveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison contamination rate of surgical glove in control group and surgical glove changing group during total knee arthroplasty procedure
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weerachai Kosuwon, Khon Kaen University
- Investigators
- Navapong Thitiworakarn, Doctor, Principal investigator, Orthopaedic Department, Faculty of Medicine, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308798
- Sponsor's protocol ID
- HE611285
- Status last verified
- Mar 2020
- First submitted
- 25 Feb 2020
- Last updated
- 16 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Surgical Glove Contamination During Total Knee Arthroplasty Procedure
- ClinicalTrials.gov ID
- NCT04308798
- Acronym / sponsor ID
- HE611285
- Conditions
- Surgical Glove, Total Knee Arthroplasty, Contamination Rate
- Keywords
- Total knee arthroplasty, Surgical glove, Contamination rate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Jul 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 16 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Comparison contamination rate of surgical glove in control group and surgical glove changing group during total knee arthroplasty procedure
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Procedure: Surgical glove changingNo surgical glove changing during total knee arthroplasty procedure |
| Treatment 1 group | Experimental | Procedure: Surgical glove changingChanging surgical glove after draping and before cementation during total knee arthroplasty procedure |
| Treatment 2 group | Experimental | Procedure: Surgical glove changingChanging surgical glove before cementation during total knee arthroplasty procedure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient who schedule for primary total knee arthroplasty
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical glove changingChanging surgical glove after draping and before cementation during total knee arthroplasty | Procedure or surgery | Control group, Treatment 1 group, Treatment 2 group |
Primary outcome
comparison contamination rate on surgical glove
Time frame: 30 months from randomization
Contamination rate on surgical glove during total knee arthroplasty
1 secondary outcome
Contamination rate on surgical glove
Time frame: 30 months from randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Navapong Thitiworakarn, Doctor principal investigator
Orthopaedic Department, Faculty of Medicine, Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Surgical glove changing in people with Surgical Glove and Total Knee Arthroplasty, run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kamolsak sukontaman, Doctor (0816557443, kamolsu@kku.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison contamination rate on surgical glove (time frame: 30 months from randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2020.