Surgical GlovesNCT06042088
Effect of Double Surgical Glove on Comfort, Sensitivity and Dexterity
A study testing Regular Size Glove and Bigger One in people with Surgical Gloves, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Gloves
- What is being tested?
- Regular Size Glove and Bigger One
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Sep 2023to 3 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Taking part in the surgical team Six months or more of surgical experience
Who cannot join
- Latex allergic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effect of Glove Number on Comfort, Sensitivity, and Dexterity in the Use of Double Surgical Gloves
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.
Read the 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.
- Conditions
- Surgical Gloves
- Being tested
- Regular Size Glove and Bigger One
- Keywords
- Surgical gloves, Comfort, Dexterity, Sensitivity
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular Size Glove and Bigger OneOther
Different sizes of surgical gloves will be worn by participants
| Study group | Role | What they receive |
|---|---|---|
| Double Gloves:Regular Size | Experimental | Procedure A: Double gloves, participants will wear both gloves in their surgical glove size. Receives: 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 Receives: 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. Receives: Other: Regular Size Glove and Bigger One |
| One Glove | No intervention | Procedure D: Participants will wear only one glove. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: After 90-120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start3 Sep 2023
- Primary completion15 Oct 2023
- Study completion3 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Surgical GlovesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neslihan Ilkaz, Ankara Medipol University
- Investigators
- Neslihan Ilkaz, Principal investigator, Ankara Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042088
- Sponsor's protocol ID
- 2023/170
- Status last verified
- Oct 2023
- First submitted
- 5 Sep 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 22342011Bouvet 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.
PubMed 19653826Schmauss 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.
PubMed 26306813Mylon 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.
PubMed 278818068. World Health Organization (WHO), Global guidelines for the prevention of surgical site infection, 2nd ed.,2018. Erişim 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.
PubMed 33433290Han 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.
PubMed 23747130Moog 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.
PubMed 32904254Zhang 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.
PubMed 33733484Parlak 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. 2026 Mar;32(1):80-86. doi: 10.1080/10803548.2025.2503580. Epub 2025 Jun 9.
PubMed 40485595
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Glove Number on Comfort, Sensitivity, and Dexterity in the Use of Double Surgical Gloves
- ClinicalTrials.gov ID
- NCT06042088
- Acronym / sponsor ID
- 2023/170
- Conditions
- Surgical Gloves
- Keywords
- Surgical gloves, Comfort, Dexterity, Sensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ankara Medipol UniversityUniversity, hospital or other
- Study start
- 3 Sep 2023 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 3 Nov 2023 (estimated)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Double Gloves:Regular Size | Experimental | Other: Regular Size Glove and Bigger OneProcedure A: Double gloves, participants will wear both gloves in their surgical glove size. |
| Double Gloves: Regular Size and Half-Size Bigger | Experimental | Other: Regular Size Glove and Bigger OneProcedure B: Double gloves, Participants will wear their own glove size and half-size bigger glove on top |
| Double Gloves: Half-Size Bigger and Regular Size | Experimental | Other: Regular Size Glove and Bigger OneProcedure C: Double gloves, participants will wear a half-size big glove and their own glove size on top. |
| One Glove | No intervention | –Procedure D: Participants will wear only one glove. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Taking part in the surgical team Six months or more of surgical experience
Key exclusion criteria (1 listed)
- Latex allergic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regular Size Glove and Bigger OneDifferent sizes of surgical gloves will be worn by participants | Other | Double Gloves: Half-Size Bigger and Regular Size, Double Gloves: Regular Size and Half-Size Bigger, Double Gloves:Regular Size |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Background: PubMed 22342011Guo 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.
- Background: PubMed 19653826Bouvet 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.
- Background: PubMed 26306813Schmauss 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.
- Background: PubMed 27881806Mylon 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.
- Background8. World Health Organization (WHO), Global guidelines for the prevention of surgical site infection, 2nd ed.,2018. Erişim adresi: https://www.who.int/publications/i/item/global-guidelines-for-the-prevention-of-surgical-site-infection-2nd-ed
- Background: PubMed 33433290Basak 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.
- Background: PubMed 23747130Han 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.
- Background: PubMed 32904254Moog 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.
- Background: PubMed 33733484Zhang 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.
- Derived from this study: PubMed 40485595Parlak 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. 2026 Mar;32(1):80-86. doi: 10.1080/10803548.2025.2503580. Epub 2025 Jun 9.
Related trials for Surgical Gloves
Not yet recruiting
Sensorised Surgical Gloves for Neuroendovascular Procedures
Endovascular Procedures, Force Sensing Surgical Gloves
Not yet recruiting
Surgical Glove Compression to Prevent Paclitaxel Neuropathy
Paclitaxel-Induced Peripheral Neuropathy, Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neslihan Ilkaz principal investigator
Ankara Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular Size Glove and Bigger One in people with Surgical Gloves, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from comfort, sensitivity, and dexterity after 90-120 min. (time frame: After 90-120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06042088, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.