Effect of Double Surgical Glove on Comfort, Sensitivity and Dexterity

NCT ID: NCT06042088

Last Updated: 2023-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-03

Study Completion Date

2023-11-03

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Surgical Gloves

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Double Gloves:Regular Size

Procedure A: Double gloves, participants will wear both gloves in their surgical glove size.

Group Type EXPERIMENTAL

Regular Size Glove and Bigger One

Intervention Type OTHER

Different sizes of surgical gloves will be worn by participants

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

Group Type EXPERIMENTAL

Regular Size Glove and Bigger One

Intervention Type OTHER

Different sizes of surgical gloves will be worn by participants

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.

Group Type EXPERIMENTAL

Regular Size Glove and Bigger One

Intervention Type OTHER

Different sizes of surgical gloves will be worn by participants

One Glove

Procedure D: Participants will wear only one glove.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Regular Size Glove and Bigger One

Different sizes of surgical gloves will be worn by participants

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

Latex allergic
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara Medipol University

OTHER

Sponsor Role lead

Responsible Party

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Neslihan Ilkaz

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Neslihan Ilkaz

Role: PRINCIPAL_INVESTIGATOR

Ankara Medipol University

Locations

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Neslihan Ilkaz

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 22342011 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19653826 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26306813 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27881806 (View on PubMed)

Global Guidelines for the Prevention of Surgical Site Infection. Geneva: World Health Organization; 2018. Available from http://www.ncbi.nlm.nih.gov/books/NBK536404/

Reference Type BACKGROUND
PMID: 30689333 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33433290 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23747130 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32904254 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33733484 (View on PubMed)

Parlak EA, Ilkaz N, Ayhan H, Iyigun E. Comparison of the effect of glove size on comfort, sensitivity and dexterity in the use of double surgical gloves: a randomized controlled trial. Int J Occup Saf Ergon. 2025 Jun 9:1-7. doi: 10.1080/10803548.2025.2503580. Online ahead of print.

Reference Type DERIVED
PMID: 40485595 (View on PubMed)

Other Identifiers

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2023/170

Identifier Type: -

Identifier Source: org_study_id

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