Gloves, SurgicalInDureNCT03344354
Durability of Double-gloving With Biogel® Surgical Gloves When Used by Clinicians/Surgeons
A study testing Biogel, Ansell and Cardinal in people with Gloves, Surgical, run by Molnlycke Health Care AB at 1 site in United States.
Trial summary
A prospective open-label study design was chosen because it will provide the most accurate data on the efficacy of four commercially available similar brands of NRL (natural rubber latex) and synthetic latex surgical gloves when they are used for surgeries in a clinical setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gloves, Surgical
- What is being tested?
- Biogel, Ansell and Cardinal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,507 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2018to 26 Oct 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All study clinicians, i.e. study glove wearers, must meet all of the following Inclusion Criteria in order to be included in the investigation:
- Must be certified and licensed physician or a clinician in training under supervision in Orthopedic, Neurosurgery, Cardiothoracic, Colorectal or Trauma specialty surgery services or be working in other OR support functions;
- Directly take part in the surgical procedure work within the sterile field;
- Be willing to wear half size larger underglove if recommended by the manufacturer.
- Perform one of the five target procedure groups which is scheduled to last a minimum of 1 hour;
- Be a current employee or active medical staff member with privileges at the institution conducting the clinical investigation;
- Be willing and able to participate in the written user survey and other tasks associated with the clinical investigation and evaluation of the surgical gloves;
- Be willing and able to read, understand and sign the participant information and consent form prior to the initiation of the clinical investigation.
Who cannot join
- All potential study participants who meets any of the following Exclusion Criteria will not be included in the investigation:
- Has had or currently has dermatological or other medical conditions that may prevent proper scrub technique and the use of the sterile study surgical gloves for the duration of the participation in the procedure or the span of time the investigation is to take place;
- Wearing of rings, bracelets, or other jewelry that cannot be removed during glove evaluation;
- Incomplete or absent training on the current clinical investigation plan and study participation responsibilities; and
- Is an employee or staff member of the Sponsor, CRO or any other glove manufacturer; or is an immediate relative of an employee of the Sponsor, CRO or any other glove manufacturer.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: InDure: A Clinical Investigation Comparing the In-Use Durability of Double-gloving With Biogel® Surgical Gloves to Three Comparators
A prospective open-label study design was chosen because it will provide the most accurate data on the efficacy of four commercially available similar brands of NRL (natural rubber latex) and synthetic latex surgical gloves when they are used for surgeries in a clinical setting. The primary endpoint will be the overall failure rate of the Biogel® sterile surgical undergloves (device) compared to three undergloves brands of surgical gloves. The secondary endpoints are perforation rates of the underglove, the failure rate of the overglove, the frequency of overglove perforation detection by the glove wearer when double-gloving, the ratio of perforations detected of overglove compared to underglove and to determine the frequency of overglove perforation detection by the glove wearer.
The clinical investigation will be statistically powered to test the hypothesis that the failure rate of the Biogel® Sterile Surgical undergloves is different from that of the three comparators.
Read the detailed description
This is a non-significant risk, cross-over, comparative, prospective, five-armed, open-label clinical investigation in which the perforation rate of surgical gloves from four different manufacturers will be evaluated in double-gloving fashion. Study clinicians who will directly in the sterile field, with a similar surgical procedural work scope will be asked to use gloves from the four manufacturers of surgical gloves while performing surgical procedures. The types of procedures under which the study gloves will be put in use are prosthetic joints arthroplasty and implantation (i.e. orthopedic), trauma surgery, neurosurgery, colorectal and cardiothoracic surgery.
All gloves under evaluation in each phase will be assessed for perforation rate and overall failure on the basis of binomial responses (Y/N) looking at five time points:
- glove failure pre-donning (after removal from pack, prior to donning)
- glove failure during donning (putting the gloves on)
- observed intraoperative glove failure
- glove failure during doffing (glove removal)
- post-procedure: glove perforation and failure determined using a standardized water leak test
No patients have been enrolled in this study therefore no patient data will be assessed.
- Conditions
- Gloves, Surgical
- Being tested
- Biogel, Ansell, Cardinal, Medline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiogelDevice
Sterile surgical gloves used during surgical procedures.
AnsellDevice
Sterile surgical gloves used during surgical procedures.
CardinalDevice
Sterile surgical gloves used during surgical procedures.
MedlineDevice
Sterile surgical gloves used during surgical procedures.
| Study group | Role | What they receive |
|---|---|---|
| Brand 1 | Active comparator | sterile surgical gloves Two arms of Brand 1 were combined to allow comparison of the total of all comparator gloves. Receives: Device: Biogel |
| Brand 2 | Active comparator | sterile surgical gloves Receives: Device: Ansell |
| Brand 3 | Active comparator | sterile surgical gloves Receives: Device: Cardinal |
| Brand 4 | Active comparator | sterile sergical gloves Receives: Device: Medline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Underglove failure rate compared between all competitors
To determine and compare the failure rate of the Biogel® natural rubber latex (NRL) and synthetic latex study underglove assortment to all competitors combined as non-Biogel.
Measured: Procedures that are scheduled to last a minimum of one (1) hour long
Underglove failure rate compared to each of the three comparators
To determine and compare the failure rate of the Biogel® natural rubber latex (NRL) and synthetic latex study underglove assortment to each of the three comparators.
Measured: Procedures that are scheduled to last a minimum of one (1) hour long
Secondary outcomes (1)
Underglove perforation rate compared to each of the three comparators comparators separately and combined as non-Biogel.
To determine and compare the perforation rate of the Biogel® NRL and synthetic latex study underglove assortment to that of the three comparators separately and combined as non-Biogel.
Measured: Procedures that are scheduled to last a minimum of one (1) hour long
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start10 Apr 2018
- Primary completion18 Nov 2021
- Study completion26 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gloves, SurgicalStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a non-significant risk, crossover, comparative, prospective, five-armed, open-label clinical investigation in which failure rates of surgical gloves from four manufacturers will be evaluated in double-gloving fashion. The investigation is to be conducted over the course of ten (10) periods where the Biogel® brand of NRL and synthetic latex overgloves and undergloves are compared to other brand products from three manufacturers with comparable glove materials and thickness, and used during similar types of procedures. Study clinicians will be divided into five study groups based on specialty: Cardiothoracic and plastic surgery, Neurosurgery, Orthopaedic surgery, Trauma and acute general surgery, and Colorectal surgery. Before the first period each of five study groups will be randomized to one glove brand to start with in period 1. After each period the study group will cross over to the next period and brand of gloves according to a pre-defined order of rotation.
- Masking
- None (open label)
- Enrolment
- 3,507 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michelle Doll, MD, MPH, Principal investigator, Virginia Commonwealth University HealthGonzalo M.L. Bearman, Principal investigator, Virginia Commonwealth University Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344354
- Sponsor's protocol ID
- InDure_G016-002
- Acronym
- InDure
- Status last verified
- Aug 2023
- First submitted
- 9 Nov 2017
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Doll M, Namoos A, Kang L, Satpathy J, Feldman MJ, Cassano A, Bohl J, Aboutanos MB, Cameron B, Kim J, Asbury C, Haque M, Hess O, Ahlbom H, Bearman G. A randomized trial comparing the intraoperative durability of double-gloving with Biogel(R) surgical gloves to 3 comparators. Antimicrob Steward Healthc Epidemiol. 2024 Oct 10;4(1):e169. doi: 10.1017/ash.2024.431. eCollection 2024.
PubMed 39430795
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- InDure: A Clinical Investigation Comparing the In-Use Durability of Double-gloving With Biogel® Surgical Gloves to Three Comparators
- ClinicalTrials.gov ID
- NCT03344354
- Acronym / sponsor ID
- InDure / InDure_G016-002
- Conditions
- Gloves, Surgical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,507 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 18 Nov 2021 (actual)
- Study completion
- 26 Oct 2022 (actual)
- First posted
- 17 Nov 2017 (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.
A prospective open-label study design was chosen because it will provide the most accurate data on the efficacy of four commercially available similar brands of NRL (natural rubber latex) and synthetic latex surgical gloves when they are used for surgeries in a clinical setting. The primary endpoint will be the overall failure rate of the Biogel® sterile surgical undergloves (device) compared to three undergloves brands of surgical gloves. The secondary endpoints are perforation rates of the underglove, the failure rate of the overglove, the frequency of overglove perforation detection by the glove wearer when double-gloving, the ratio of perforations detected of overglove compared to underglove and to determine the frequency of overglove perforation detection by the glove wearer.
The clinical investigation will be statistically powered to test the hypothesis that the failure rate of the Biogel® Sterile Surgical undergloves is different from that of the three comparators.
Detailed description
This is a non-significant risk, cross-over, comparative, prospective, five-armed, open-label clinical investigation in which the perforation rate of surgical gloves from four different manufacturers will be evaluated in double-gloving fashion. Study clinicians who will directly in the sterile field, with a similar surgical procedural work scope will be asked to use gloves from the four manufacturers of surgical gloves while performing surgical procedures. The types of procedures under which the study gloves will be put in use are prosthetic joints arthroplasty and implantation (i.e. orthopedic), trauma surgery, neurosurgery, colorectal and cardiothoracic surgery.
All gloves under evaluation in each phase will be assessed for perforation rate and overall failure on the basis of binomial responses (Y/N) looking at five time points:
- glove failure pre-donning (after removal from pack, prior to donning)
- glove failure during donning (putting the gloves on)
- observed intraoperative glove failure
- glove failure during doffing (glove removal)
- post-procedure: glove perforation and failure determined using a standardized water leak test
No patients have been enrolled in this study therefore no patient data will be assessed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a non-significant risk, crossover, comparative, prospective, five-armed, open-label clinical investigation in which failure rates of surgical gloves from four manufacturers will be evaluated in double-gloving fashion. The investigation is to be conducted over the course of ten (10) periods where the Biogel® brand of NRL and synthetic latex overgloves and undergloves are compared to other brand products from three manufacturers with comparable glove materials and thickness, and used during similar types of procedures. Study clinicians will be divided into five study groups based on specialty: Cardiothoracic and plastic surgery, Neurosurgery, Orthopaedic surgery, Trauma and acute general surgery, and Colorectal surgery. Before the first period each of five study groups will be randomized to one glove brand to start with in period 1. After each period the study group will cross over to the next period and brand of gloves according to a pre-defined order of rotation.
| Arm | Type | Receives |
|---|---|---|
| Brand 1 | Active comparator | Device: Biogelsterile surgical gloves Two arms of Brand 1 were combined to allow comparison of the total of all comparator gloves. |
| Brand 2 | Active comparator | Device: Ansellsterile surgical gloves |
| Brand 3 | Active comparator | Device: Cardinalsterile surgical gloves |
| Brand 4 | Active comparator | Device: Medlinesterile sergical gloves |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- All study clinicians, i.e. study glove wearers, must meet all of the following Inclusion Criteria in order to be included in the investigation:
- Must be certified and licensed physician or a clinician in training under supervision in Orthopedic, Neurosurgery, Cardiothoracic, Colorectal or Trauma specialty surgery services or be working in other OR support functions;
- Directly take part in the surgical procedure work within the sterile field;
- Be willing to wear half size larger underglove if recommended by the manufacturer.
- Perform one of the five target procedure groups which is scheduled to last a minimum of 1 hour;
Key exclusion criteria (5 listed)
- All potential study participants who meets any of the following Exclusion Criteria will not be included in the investigation:
- Has had or currently has dermatological or other medical conditions that may prevent proper scrub technique and the use of the sterile study surgical gloves for the duration of the participation in the procedure or the span of time the investigation is to take place;
- Wearing of rings, bracelets, or other jewelry that cannot be removed during glove evaluation;
- Incomplete or absent training on the current clinical investigation plan and study participation responsibilities; and
- Is an employee or staff member of the Sponsor, CRO or any other glove manufacturer; or is an immediate relative of an employee of the Sponsor, CRO or any other glove manufacturer.
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 |
|---|---|---|
| BiogelSterile surgical gloves used during surgical procedures. | Device | Brand 1 |
| AnsellSterile surgical gloves used during surgical procedures. | Device | Brand 2 |
| CardinalSterile surgical gloves used during surgical procedures. | Device | Brand 3 |
| MedlineSterile surgical gloves used during surgical procedures. | Device | Brand 4 |
Primary outcome
Underglove failure rate compared between all competitors
Time frame: Procedures that are scheduled to last a minimum of one (1) hour long
To determine and compare the failure rate of the Biogel® natural rubber latex (NRL) and synthetic latex study underglove assortment to all competitors combined as non-Biogel.
Underglove failure rate compared to each of the three comparators
Time frame: Procedures that are scheduled to last a minimum of one (1) hour long
To determine and compare the failure rate of the Biogel® natural rubber latex (NRL) and synthetic latex study underglove assortment to each of the three comparators.
1 secondary outcome
Underglove perforation rate compared to each of the three comparators comparators separately and combined as non-Biogel.
Time frame: Procedures that are scheduled to last a minimum of one (1) hour long
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Derived from this study: PubMed 39430795Doll M, Namoos A, Kang L, Satpathy J, Feldman MJ, Cassano A, Bohl J, Aboutanos MB, Cameron B, Kim J, Asbury C, Haque M, Hess O, Ahlbom H, Bearman G. A randomized trial comparing the intraoperative durability of double-gloving with Biogel(R) surgical gloves to 3 comparators. Antimicrob Steward Healthc Epidemiol. 2024 Oct 10;4(1):e169. doi: 10.1017/ash.2024.431. eCollection 2024.
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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.
Michelle Doll, MD, MPH principal investigator
Virginia Commonwealth University Health
Gonzalo M.L. Bearman principal investigator
Virginia Commonwealth University Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biogel, Ansell and Cardinal in people with Gloves, Surgical, run by Molnlycke Health Care AB at 1 site in United States.
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 8 inclusion and 5 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: finished, as of the sponsor's last update on 22 Aug 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Underglove failure rate compared between all competitors (time frame: Procedures that are scheduled to last a minimum of one (1) hour long). The study lists 2 primary outcomes in all. 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 NCT03344354, which also lists 1 linked publication.
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 22 Aug 2023.