Clinical Trial Results:
The efficacy and safety of two topical antiseptic solutions for skin disinfection prior to percutaneous central venous catheter insertion in preterm neonates: a feasibility study
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Summary
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EudraCT number |
2015-000874-36 |
Trial protocol |
GB |
Global end of trial date |
15 Oct 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
01 May 2020
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First version publication date |
01 May 2020
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
2014PAED13L
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Additional study identifiers
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ISRCTN number |
ISRCTN82571474 | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Norfolk and Norwich University Hospitals NHS Foundation Trust
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Sponsor organisation address |
Colney Lane, Norwich, United Kingdom, NR4 7UY
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Public contact |
R+D Office, Norfolk and Norwich University Hospitals NHS Trust, +44 01603 286614, Lisa.Chalkley@nnuh.nhs.uk
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Scientific contact |
R+D Office, Norfolk and Norwich University Hospitals NHS Foundation Trust, +44 01603 286614, Lisa.Chalkley@nnuh.nhs.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
21 Jan 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
15 Oct 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
15 Oct 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
This is a small feasibility study of a group of babies whose skin will get cleaned with either aqueous- or alcohol-based formulations of 2% chlorhexidine antiseptic at the time of percutaneous central venous catheter (PCVC) insertion. Both the active ingredients in these antiseptics are presently very widely used, either alone or in combination, for skin disinfection in neonates in the UK, Europe, and North America. The primary objective is to obtain an estimate of what proportion of babies treated with the alcoholic version (2% chlorhexidine in 70% isopropyl alcohol) have PCVCs that are colonised with bacteria at the time that their catheters are removed. This will directly inform the sample size calculation for a future large-scale trial.
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Protection of trial subjects |
not applicable
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Dec 2015
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 116
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Worldwide total number of subjects |
116
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EEA total number of subjects |
116
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
116
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||||||||
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Pre-assignment
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Screening details |
207 assessed for eligibility. 29 were not eligible, 62 were eligible but not recruited, 116 were randomised. | |||||||||||||||
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Period 1
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Period 1 title |
Trial entry
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||
Roles blinded |
Investigator, Monitor, Data analyst, Carer, Subject, Assessor | |||||||||||||||
Blinding implementation details |
Blinding of Trial Medication:
The two antiseptic IMPs will be supplied in bottles. The products will each be coloured pink (using carmoisine) and so will be visually indistinguishable from each other. To maintain blinding, each baby will be issued a unique allocation number that will correspond to the study pack number.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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2%CHG | |||||||||||||||
Arm description |
Aqueous-based 2% chlorhexidine gluconate | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
Chlorhexidine Gluconate 2% aqueous solution
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Topical use
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Dosage and administration details |
The operator will:
• apply the allocated antiseptic solution to the skin over the area selected for catheter insertion for a minimum of 10 seconds and maximum of 20 seconds
• take great care to use only the minimal volume of antiseptic necessary for skin coverage, avoid any pooling of antiseptic, and ensure that any excess solution and any soaked materials, drapes, or gowns are removed to avoid any prolonged contact with the skin
• allow the disinfected area to air dry completely (for ≥30 seconds) before proceeding with catheter insertion
• not use saline or water to wipe off the disinfected skin area at any time after application of antiseptic solution before catheterisation, because this practice potentially negates the efficacy of the antiseptic, will therefore potentially confound the study findings, and will constitute a violation of the protocol. The only exception to this is in case of failed catheterisation, as described in Sec. 7.3.10)
• insert the PCVC aseptically
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Arm title
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70%IPA/2%CHG | |||||||||||||||
Arm description |
Alcohol-based (70% isopropyl alcohol) 2% chlorhexidine gluconate | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
Chlorhexidine Gluconate 2% in isopropyl alcohol 70% solution
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Topical use
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Dosage and administration details |
The operator will: • apply the allocated antiseptic solution to the skin over the area selected for catheter insertion for a minimum of 10 seconds and maximum of 20 seconds
• take great care to use only the minimal volume of antiseptic necessary for skin coverage, avoid any pooling of antiseptic, and ensure that any excess solution and any soaked materials, drapes, or gowns are removed to avoid any prolonged contact with the skin
• allow the disinfected area to air dry completely (for ≥30 seconds) before proceeding with catheter insertion
• not use saline or water to wipe off the disinfected skin area at any time after application of antiseptic solution before catheterisation, because this practice potentially negates the efficacy of the antiseptic, will therefore potentially confound the study findings, and will constitute a violation of the protocol. The only exception to this is in case of failed catheterisation, as described in Sec. 7.3.10)
• insert the PCVC aseptically
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Period 2
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Period 2 title |
Outcomes
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Is this the baseline period? |
No | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst, Carer, Assessor | |||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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2%CHG | |||||||||||||||
Arm description |
Aqueous-based 2% chlorhexidine gluconate | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
Chlorhexidine Gluconate 2% aqueous solution
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Topical use
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Dosage and administration details |
The operator will:
• apply the allocated antiseptic solution to the skin over the area selected for catheter insertion for a minimum of 10 seconds and maximum of 20 seconds
• take great care to use only the minimal volume of antiseptic necessary for skin coverage, avoid any pooling of antiseptic, and ensure that any excess solution and any soaked materials, drapes, or gowns are removed to avoid any prolonged contact with the skin
• allow the disinfected area to air dry completely (for ≥30 seconds) before proceeding with catheter insertion
• not use saline or water to wipe off the disinfected skin area at any time after application of antiseptic solution before catheterisation, because this practice potentially negates the efficacy of the antiseptic, will therefore potentially confound the study findings, and will constitute a violation of the protocol. The only exception to this is in case of failed catheterisation, as described in Sec. 7.3.10)
• insert the PCVC aseptically
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Arm title
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70%IPA/2%CHG | |||||||||||||||
Arm description |
Alcohol-based (70% isopropyl alcohol) 2% chlorhexidine gluconate | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
Chlorhexidine Gluconate 2% in isopropyl alcohol 70% solution
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Topical use
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Dosage and administration details |
The operator will: • apply the allocated antiseptic solution to the skin over the area selected for catheter insertion for a minimum of 10 seconds and maximum of 20 seconds
• take great care to use only the minimal volume of antiseptic necessary for skin coverage, avoid any pooling of antiseptic, and ensure that any excess solution and any soaked materials, drapes, or gowns are removed to avoid any prolonged contact with the skin
• allow the disinfected area to air dry completely (for ≥30 seconds) before proceeding with catheter insertion
• not use saline or water to wipe off the disinfected skin area at any time after application of antiseptic solution before catheterisation, because this practice potentially negates the efficacy of the antiseptic, will therefore potentially confound the study findings, and will constitute a violation of the protocol. The only exception to this is in case of failed catheterisation, as described in Sec. 7.3.10)
• insert the PCVC aseptically
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| Notes [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period. Justification: In the 70%IPA/2%CHG arm, 87 participants provided baseline information, but for 8 of these their line insertion was never successful, so they could not go on to provide clinical outcomes. Therefore, the number starting the outcomes period is 79, rather than 87. |
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Baseline characteristics reporting groups
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Reporting group title |
2%CHG
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Reporting group description |
Aqueous-based 2% chlorhexidine gluconate | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
70%IPA/2%CHG
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Reporting group description |
Alcohol-based (70% isopropyl alcohol) 2% chlorhexidine gluconate | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
2%CHG - inc in baseline characteristics
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Subject analysis set type |
Modified intention-to-treat | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Post-randomisation exclusions:
After randomisation, in the following circumstances infants will be excluded from the analysis population(s):
(i) major protocol non-compliance
(ii) infants for whom consent to use their data has been withdrawn
(iii) infants that did not receive either intervention because no study catheter insertion attempt was ever made for them
Descriptive analysis population:
Baseline neonatal and maternal characteristics will be reported for all infants randomised for whom we have data available, excluding post-randomisation exclusions.
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Subject analysis set title |
70%IPA/2%CHG - inc in baseline characteristics
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Subject analysis set type |
Modified intention-to-treat | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Post-randomisation exclusions:
After randomisation, in the following circumstances infants will be excluded from the analysis population(s):
(i) major protocol non-compliance
(ii) infants for whom consent to use their data has been withdrawn
(iii) infants that did not receive either intervention because no study catheter insertion attempt was ever made for them
Descriptive analysis population:
Baseline neonatal and maternal characteristics will be reported for all infants randomised for whom we have data available, excluding post-randomisation exclusions.
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Subject analysis set title |
2%CHG - analysed for clinical outcomes
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Subject analysis set type |
Modified intention-to-treat | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Excluding infants with no line insertion attempted (1) or line insertion never successful (0).
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Subject analysis set title |
70%IPA/2%CHG - analysed for clinical outcomes
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Subject analysis set type |
Modified intention-to-treat | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Excluding infants with no line insertion attempted (1) or line insertion never successful (8).
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Subject analysis set title |
Analysed for clinical outcomes (total)
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Subject analysis set type |
Modified intention-to-treat | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All participants randomised who had a successfully inserted catheter and received the intervention
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End points reporting groups
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Reporting group title |
2%CHG
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Reporting group description |
Aqueous-based 2% chlorhexidine gluconate | ||
Reporting group title |
70%IPA/2%CHG
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Reporting group description |
Alcohol-based (70% isopropyl alcohol) 2% chlorhexidine gluconate | ||
Reporting group title |
2%CHG
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Reporting group description |
Aqueous-based 2% chlorhexidine gluconate | ||
Reporting group title |
70%IPA/2%CHG
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Reporting group description |
Alcohol-based (70% isopropyl alcohol) 2% chlorhexidine gluconate | ||
Subject analysis set title |
2%CHG - inc in baseline characteristics
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Subject analysis set type |
Modified intention-to-treat | ||
Subject analysis set description |
Post-randomisation exclusions:
After randomisation, in the following circumstances infants will be excluded from the analysis population(s):
(i) major protocol non-compliance
(ii) infants for whom consent to use their data has been withdrawn
(iii) infants that did not receive either intervention because no study catheter insertion attempt was ever made for them
Descriptive analysis population:
Baseline neonatal and maternal characteristics will be reported for all infants randomised for whom we have data available, excluding post-randomisation exclusions.
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Subject analysis set title |
70%IPA/2%CHG - inc in baseline characteristics
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Subject analysis set type |
Modified intention-to-treat | ||
Subject analysis set description |
Post-randomisation exclusions:
After randomisation, in the following circumstances infants will be excluded from the analysis population(s):
(i) major protocol non-compliance
(ii) infants for whom consent to use their data has been withdrawn
(iii) infants that did not receive either intervention because no study catheter insertion attempt was ever made for them
Descriptive analysis population:
Baseline neonatal and maternal characteristics will be reported for all infants randomised for whom we have data available, excluding post-randomisation exclusions.
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Subject analysis set title |
2%CHG - analysed for clinical outcomes
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Subject analysis set type |
Modified intention-to-treat | ||
Subject analysis set description |
Excluding infants with no line insertion attempted (1) or line insertion never successful (0).
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Subject analysis set title |
70%IPA/2%CHG - analysed for clinical outcomes
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Subject analysis set type |
Modified intention-to-treat | ||
Subject analysis set description |
Excluding infants with no line insertion attempted (1) or line insertion never successful (8).
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Subject analysis set title |
Analysed for clinical outcomes (total)
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Subject analysis set type |
Modified intention-to-treat | ||
Subject analysis set description |
All participants randomised who had a successfully inserted catheter and received the intervention
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End point title |
Catheter colonisation as determined by positive bacterial culture from at least one of the two catheter segments taken at catheter removal [1] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
At catheter removal
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Feasibility study, no comparative analysis planned |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Proportion of babies with catheter colonisation [2] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
At catheter removal
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Feasibility study, no comparative analysis planned |
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| No statistical analyses for this end point | |||||||||
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End point title |
Positive exit-site skin swab at catheter removal (before disinfection) | ||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
At catheter removal
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Positive exit site skin swab at catheter removal (after disinfection) | ||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
At catheter removal
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Culture positive catheter segments at removal | ||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
At catheter removal
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Culture positive catheter segments at removal: Positive tip alone | ||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
At catheter removal
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Culture positive catheter segments at removal: Positive proximal segment alone | |||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
At catheter removal
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| No statistical analyses for this end point | ||||||||||||||||
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End point title |
Culture positive catheter segments at removal: Both tip and proximal segment positive | ||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
At catheter removal
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Definite catheter-related sepsis | ||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
After catheter removal
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Catheter-associated sepsis | ||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
After catheter removal
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Retention: Remained in the study | |||||||||||||||
End point description |
Feasibility metric. Proportion of infants that remained in the study to provide complete primary outcome and safety data.
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End point type |
Other pre-specified
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End point timeframe |
Randomisation to end
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| No statistical analyses for this end point | ||||||||||||||||
|
|||||||||||||
End point title |
Retention: Proportion who remained in the study | ||||||||||||
End point description |
Feasibility metric. Proportion of infants that remained in the study to provide complete primary outcome and safety data.
|
||||||||||||
End point type |
Other pre-specified
|
||||||||||||
End point timeframe |
Randomisation to end
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||
End point title |
Infants with no missing data collection forms | ||||||||||
End point description |
Feasibility metric.
|
||||||||||
End point type |
Other pre-specified
|
||||||||||
End point timeframe |
Randomisation to end
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
||||||||||||||||
|
Adverse events information [1]
|
||||||||||||||||
Timeframe for reporting adverse events |
From the time of the first application of IMP antiseptic until 2 days after the final application of trial antiseptic during PCVC removal, and for 2 days after application of trial antiseptic in cases of unsuccessful PCVC insertion.
|
|||||||||||||||
Adverse event reporting additional description |
A high incidence of adverse events is foreseeable due to the nature of the patient population and their routine care/ treatment. Consequently, only those adverse events identified as serious will be recorded for the trial.
|
|||||||||||||||
Assessment type |
Non-systematic | |||||||||||||||
|
Dictionary used for adverse event reporting
|
||||||||||||||||
Dictionary name |
N/A | |||||||||||||||
Dictionary version |
0
|
|||||||||||||||
|
Reporting groups
|
||||||||||||||||
Reporting group title |
2%CHG
|
|||||||||||||||
Reporting group description |
Aqueous-based 2% chlorhexidine gluconate | |||||||||||||||
Reporting group title |
70%IPA/2%CHG
|
|||||||||||||||
Reporting group description |
Alcohol-based (70% isopropyl alcohol) 2% chlorhexidine gluconate | |||||||||||||||
|
||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||
|
||||||||||||||||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: As per protocol, not reported |
||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
