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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Kamolsak sukontaman, Doctor contact

0816557443

kamolsu@kku.ac.th

Weerachai Kowsuwon, Professor contact

0812625055

weera_ko@kku.ac.th

Thailand1 site, 1 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

    Recruiting

Other trials in Thailand

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

  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
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 groups in NCT04308798
Study groupRoleWhat they receive
Control groupExperimentalNo surgical glove changing during total knee arthroplasty procedure
Receives: Procedure: Surgical glove changing
Treatment 1 groupExperimentalChanging surgical glove after draping and before cementation during total knee arthroplasty procedure
Receives: Procedure: Surgical glove changing
Treatment 2 groupExperimentalChanging 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.

  1. comparison contamination rate on surgical glove

    Contamination rate on surgical glove during total knee arthroplasty

    Measured: 30 months from randomization

Secondary outcomes (1)
  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.

  1. First posted16 Mar 2020
  2. Study startJul 2020 (estimated)
  3. Primary completionDec 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

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)
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

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.

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