Clinical trial NCT05928663: The Effect of Using Double Gloves on Perforation in Orthopedic Surgery
Official title: The Effect on Puncture of the Use of Double Gloves in Orthopedic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Puncture
Surgical Gloves
Orthopedic Disorder
Lead sponsor: Celal Bayar University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 1170
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: The sample size of the study was calculated based on the work of Makama et al. In the study, the perforation rate of the single glove was 15.2% and the perforation rate of the second glove in the double glove was determined as 1.17%. Considering these values, the number of gloves to be included in the intervention and control groups (in the single and double glove groups) was calculated as 249, with a 99% confidence interval (α=0.001) and 99% power in the NCSS PASS program. The total number of gloves planned to be evaluated in the intervention (double glove group, 249x2=498) and control (single glove group, 249) groups was determined as 747. The study included a total of 1170 gloves, with 780 gloves in the intervention group and 390 gloves in the control group. The allocation of gloves to the groups was determined using block randomization. The block size of 4 was selected, and all possible permutations of allocation within the block were computed. Blocks were then randomly selected to indicate the allocation of gloves to the intervention or control group.

Data Collection Tools

Patient and Surgery Information Form: In this form, which was created by examining the researches on glove perforations, there are 13 questions consisting of information about the patient, information about the surgical procedure and information about the surgical team.

Gloves Information Form: In this form, which was prepared by examining the literature, there are 16 questions such as the type of glove collected after the surgery, the team member using the glove, the dominant hand of the person using the glove, the duration of experience, the use of cement in the surgery, the time and reasons for replacing the gloves, the perforation conditions, the areas where the perforations are located Interventions Before the research, the necessary approval (Reference number: 20.05.2020/20.478.486) was obtained from the university clinical ethics committee, and the research was performed according to the principles of the Helsinki Declaration. Orthopedic surgeries other than soft tissue surgeries were included in the study.

When the patient was admitted to the operating room, the section containing the patient's information was filled out by using the patient file. On the same form, it was filled in the section containing the information about the surgical team and recorded in the form. In the intervention group, the surgical team members wore brown colored ENCORE® Latex Micro as the inner glove, while white MEDI-GRIP® Latex Standard was used as the outer glove. In the control group, only MEDI-GRIP® Latex Standard gloves were worn. All information about the gloves used in the surgery was recorded in the forms prepared by the researcher. In these forms, the team member who used the gloves, if the gloves were changed, the reason for the change and the time of replacement were stated. Making the surgical incision was defined as the beginning of the operation and the end of the operation when the incision was closed and all surgical instruments were removed from the patient. The time between the beginning and the end of the surgery in minutes was recorded on the form. The number of single and double gloves used during the surgery, the duration of the surgery and the cutting and piercing rotary devices and tools that may affect the perforations were also recorded on the forms. During the operation, the members of the surgical team were constantly monitored by the researcher. In cases where glove change was made, the reason and time of glove change were recorded by the researcher. The gloves used were placed in boxes with barcodes before hand.

All gloves collected after the surgery were tested by the researcher by standardized water leak method EN 455-1. In this method, which was applied to determine the perforation status in the gloves, 1000±50 ml of tap water was filled into the gloves. The temperature of the water was between 15-35°C. Gloves filled with water were observed for two minutes. The area where the water leak occurred was marked on the form and recorded. All fingers were lettered, starting with the little finger of the left hand, in order to more easily register the perforation areas in the gloves (left pinky: a, right pinky: j, left back: k, right back: l, left palm: m, and right palm: n). The perforations detected during the water tightness control were recorded in this order. The same test was applied to the gloves that were opened and not used for control purposes at the beginning of each operation. In the study, double gloves were worn in 55 operations in the intervention group, while single gloves were worn in 57 operations in the control group. Gloves of the same brand, which were opened on the operating table but never used, were checked for each operation. No perforations were detected total of 334 in these gloves that 220 (inner gloves 55x2=110; outer gloves 55x2=110) in the intervention group and 114 (57x2=114) in the control group. Although the number of people in the surgical team during the operation was not standard, there was definitely a surgeon and a nurse in the team. The water leak test applied to collect the gloves used after the surgery and to detect the perforations was performed by the same researcher. However, the same person who was a nurse among the surgical team members during the water leak test of all gloves was present as an observer at the time of the test.

Eligibility criteria: 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.

Primary outcomes:
measure: Investigation of Perforations Presence of Gloves by Groups
timeFrame: immediately after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Manisa
country: Turkey
facility: Manisa Celal Bayar University Faculty of Health Sciences
Study officials:
affiliation: Manisa Celal Bayar University, Faculty of Health Sciences
name: Hakan BAYDUR, Assoc. Prof.
role: STUDY_CHAIR
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