Total Knee Arthroplasty Clinical Trial
Official title:
Comparison of Surgical Glove Contamination During Total Knee Arthroplasty Procedure
NCT number | NCT04308798 |
Other study ID # | HE611285 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | July 2020 |
Est. completion date | December 2020 |
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.
Status | Recruiting |
Enrollment | 41 |
Est. completion date | December 2020 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Thailand | Orthopaedic Department, Faculty of Medicine, Khon Kaen University | Muang Khonkaen | Khon Kaen |
Lead Sponsor | Collaborator |
---|---|
Khon Kaen University |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | comparison contamination rate on surgical glove | Contamination rate on surgical glove during total knee arthroplasty | 30 months from randomization | |
Secondary | Contamination rate on surgical glove | Contamination rate on surgical glove during period after draping and before cementation | 30 months from randomization |
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