Effect of Double Surgical Glove on Comfort, Sensitivity and Dexterity

Overview

This clinical trial aims to test the effect of double surgical gloves worn in different sizes on the surgical team's comfort, sensitivity, and dexterity.

Full Title of Study: “Comparison of the Effect of Glove Number on Comfort, Sensitivity, and Dexterity in the Use of Double Surgical Gloves”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 3, 2023

Detailed Description

The purpose of using surgical gloves is to create a protective barrier against blood-borne pathogens. According to studies, gloves can puncture during surgical procedures. Many studies recommend wearing double gloves. However, the World Health Organization reported that in the guideline for surgical site infections published in 2018, there is not enough evidence for wearing double or single gloves to prevent surgical site infections. However, he recommends that the surgical team prefer to use double gloves to protect themselves against punctures. Although wearing double gloves is considered to be positive in terms of patient and employee safety, it is not preferred by the surgical team in some cases. The sense of touch and sensitivity of the human hand is at the center of surgical procedures. Finger pulp is extremely sensitive and contains many sensory receptors. Placing a barrier, such as a glove, between these sensory receptors and the touched surface may prevent tactile sensitivity in surgical applications. In addition to the advantages of double gloves in terms of patient and employee safety, there are disadvantages such as reduced dexterity and touch sensitivity. In the literature, it has been determined that there are few and old studies examining the effects of double glove use on performance and comfort. Therefore, this study, it was aimed to compare the effects of double surgical gloves worn in different procedures or usage habits (double gloves, large and small gloves) on the comfort, sensitivity, and dexterity of the surgical team. The study will conduct as a prospective randomized controlled trial. After obtaining verbal and written consent from the participant, the study will conduct with various data collection forms. These forms are; the introductory information form, surgical glove evaluation form, and Visual Analogue Scale. Participants will randomize. After randomization, participants will be included in one of four groups. All procedures will be applied to participants in all groups. Group I (n=20), Group II (n=20), Group III (n=20), Group IV (n=20). Procedure A: Double gloves, participants will wear both gloves in their surgical glove size. Procedure B: Double gloves, participants will wear their own glove number and half a size bigger glove on top. Procedure C: Double gloves, participants will wear a half-size big glove and their own glove number on top. Procedure D: Participants will wear one glove (control procedure). Open surgeries with a duration of 90-120 minutes will be preferred for evaluation.

Interventions

  • Other: Regular Size Glove and Bigger One
    • Different sizes of surgical gloves will be worn by participants

Arms, Groups and Cohorts

  • Experimental: Double Gloves:Regular Size
    • Procedure A: Double gloves, participants will wear both gloves in their surgical glove size.
  • Experimental: Double Gloves: Regular Size and Half-Size Bigger
    • Procedure B: Double gloves, Participants will wear their own glove size and half-size bigger glove on top
  • Experimental: Double Gloves: Half-Size Bigger and Regular Size
    • Procedure C: Double gloves, participants will wear a half-size big glove and their own glove size on top.
  • No Intervention: One Glove
    • Procedure D: Participants will wear only one glove.

Clinical Trial Outcome Measures

Primary Measures

  • Change from comfort, sensitivity, and dexterity after 90-120 min.
    • Time Frame: After 90-120 minutes
    • In this section, the degree of comfort, sensitivity, and dexterity. This status will be evaluated with Visual Analogue Scale. In Visual Analogue Scale we use between 0-10 point (0= most uncomfortable/ most insensitivity/ most indexterity, 10=most comfort/ most sensitivity/ most dexterity).

Participating in This Clinical Trial

Inclusion Criteria

Taking part in the surgical team Six months or more of surgical experience Exclusion Criteria:

Latex allergic

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ankara Medipol University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Neslihan Ilkaz, Assistant Professor – Ankara Medipol University
  • Overall Official(s)
    • Neslihan Ilkaz, Principal Investigator, Ankara Medipol University

References

Guo YP, Wong PM, Li Y, Or PP. Is double-gloving really protective? A comparison between the glove perforation rate among perioperative nurses with single and double gloves during surgery. Am J Surg. 2012 Aug;204(2):210-5. doi: 10.1016/j.amjsurg.2011.08.017. Epub 2012 Feb 17.

Bouvet E, Pellissier G, Abiteboul D, L'Heriteau F; Group for the Prevention of Occupational Infections in Healthcare Workers. Is double gloving an effective barrier to protect surgeons against blood exposure due to needlestick injury? Infect Control Hosp Epidemiol. 2009 Sep;30(9):928-9; author reply 929. doi: 10.1086/599309. No abstract available.

Schmauss D, Megerle K, Weinzierl A, Agua K, Cerny M, Schmauss V, Lohmeyer JA, Machens HG, Erne H. Microsurgeons do better–tactile training might prevent the age-dependent decline of the sensibility of the hand. J Peripher Nerv Syst. 2015 Dec;20(4):392-6. doi: 10.1111/jns.12144.

Mylon P, Carre MJ, Martin N, Lewis R. How do gloves affect cutaneous sensibility in medical practice? Two new applied tests. Proc Inst Mech Eng H. 2017 Jan;231(1):28-39. doi: 10.1177/0954411916679199. Epub 2016 Nov 23.

8. World Health Organization (WHO), Global guidelines for the prevention of surgical site infection, 2nd ed.,2018. Eri┼čim adresi: https://www.who.int/publications/i/item/global-guidelines-for-the-prevention-of-surgical-site-infection-2nd-ed

Basak T, Sahin G, Demirtas A. Comparison of surgical gloves: perforation, satisfaction and manual dexterity. Int J Occup Saf Ergon. 2022 Jun;28(2):1160-1166. doi: 10.1080/10803548.2021.1875636. Epub 2021 Mar 2.

Han CD, Kim J, Moon SH, Lee BH, Kwon HM, Park KK. A randomized prospective study of glove perforation in orthopaedic surgery: is a thick glove more effective? J Arthroplasty. 2013 Dec;28(10):1878-81. doi: 10.1016/j.arth.2013.05.007. Epub 2013 Jun 6.

Moog P, Schulz M, Betzl J, Schmauss D, Lohmeyer JA, Machens HG, Megerle K, Erne HC. Do your surgical glove characteristics and wearing habits affect your tactile sensibility? Ann Med Surg (Lond). 2020 Aug 8;57:281-286. doi: 10.1016/j.amsu.2020.08.002. eCollection 2020 Sep. Erratum In: Ann Med Surg (Lond). 2021 Aug 21;69:102743.

Zhang Z, Gao X, Ruan X, Zheng B. Effectiveness of double-gloving method on prevention of surgical glove perforations and blood contamination: A systematic review and meta-analysis. J Adv Nurs. 2021 Sep;77(9):3630-3643. doi: 10.1111/jan.14824. Epub 2021 Mar 17.

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