The Effect on Puncture of the Use of Double Gloves in Orthopedic Surgery

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.