Orthopedic Disorder Clinical Trial
Official title:
The Effect on Puncture of the Use of Double Gloves in Orthopedic Surgery
Verified date | July 2023 |
Source | Celal Bayar University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Aim: This study aimed to investigate the effect of using double gloves on perforation in orthopedic surgery. Materials and Method: The randomized controlled experimental study was conducted between 30.11.2021 and 31.03.2022 in the Orthopedics and Traumatology operating room of a university hospital in western Turkey. The gloves used in the surgery were randomly divided into two groups (intervention: double glove group = 780 gloves, control: single glove group = 390). The presence of holes was checked by performing a water tightness test with the EN455-1 method on all gloves collected after the surgery by the researcher. Data were evaluated with descriptive statistics, Chi-square Test, Fisher Exact Test, and linear model regression analysis (GLM for the Binomial Family Regression). Statistical significance was accepted as 0.05.
Status | Completed |
Enrollment | 1170 |
Est. completion date | July 18, 2022 |
Est. primary completion date | March 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - In the intervention group, ENCORE® Latex Micro was used as the inner glove and MEDI-GRIP® Latex Standard was used as the outer glove - MEDI-GRIP® Latex Standard gloves were used in the control group. Exclusion Criteria: - Gloves that were removed before the operation starts in cases where the surgical team member's glove is torn or contaminated for any reason. - Gloves worn by the surgical team member after changing gloves for any reason. - Gloves worn by the replacement person in cases where the surgical team members leave their place to another team member for any reason. |
Country | Name | City | State |
---|---|---|---|
Turkey | Manisa Celal Bayar University Faculty of Health Sciences | Manisa |
Lead Sponsor | Collaborator |
---|---|
Celal Bayar University |
Turkey,
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* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Investigation of Perforations Presence of Gloves by Groups | Whether there is a puncture (perforation) or not in intervention and control groups | immediately after surgery |
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