NCT06042088

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 18, 2023

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2023

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2023

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

1 month

First QC Date

September 5, 2023

Last Update Submit

October 15, 2023

Conditions

Keywords

Surgical glovesComfortDexteritySensitivity

Outcome Measures

Primary Outcomes (1)

  • Change from comfort, sensitivity, and dexterity after 90-120 min.

    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).

    After 90-120 minutes

Study Arms (4)

Double Gloves:Regular Size

EXPERIMENTAL

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

Other: Regular Size Glove and Bigger One

Double Gloves: Regular Size and Half-Size Bigger

EXPERIMENTAL

Procedure B: Double gloves, Participants will wear their own glove size and half-size bigger glove on top

Other: Regular Size Glove and Bigger One

Double Gloves: Half-Size Bigger and Regular Size

EXPERIMENTAL

Procedure C: Double gloves, participants will wear a half-size big glove and their own glove size on top.

Other: Regular Size Glove and Bigger One

One Glove

NO INTERVENTION

Procedure D: Participants will wear only one glove.

Interventions

Different sizes of surgical gloves will be worn by participants

Double Gloves: Half-Size Bigger and Regular SizeDouble Gloves: Regular Size and Half-Size BiggerDouble Gloves:Regular Size

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Latex allergic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neslihan Ilkaz

Ankara, Turkey (Türkiye)

Location

Related Publications (10)

  • 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.

    PMID: 22342011BACKGROUND
  • 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.

    PMID: 19653826BACKGROUND
  • 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.

    PMID: 26306813BACKGROUND
  • 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.

    PMID: 27881806BACKGROUND
  • Global Guidelines for the Prevention of Surgical Site Infection. Geneva: World Health Organization; 2018. Available from http://www.ncbi.nlm.nih.gov/books/NBK536404/

    PMID: 30689333BACKGROUND
  • 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.

    PMID: 33433290BACKGROUND
  • 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.

    PMID: 23747130BACKGROUND
  • 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.

    PMID: 32904254BACKGROUND
  • 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.

    PMID: 33733484BACKGROUND
  • 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.

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Neslihan Ilkaz

    Ankara Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 5, 2023

First Posted

September 18, 2023

Study Start

September 3, 2023

Primary Completion

October 15, 2023

Study Completion

November 3, 2023

Last Updated

October 17, 2023

Record last verified: 2023-10

Locations