Disinfectant Dye Adverse ReactionNCT04821193
Comparison of the Effects of 5%NaHCO3, 2%CHG and 70%Alcohol in the Prevention of Infections Related to Catheter
A study testing Skin antisepsis with 5% NaHCO3 water solution and Skin antisepsis with 2% Chlorhexidine Gluconate solution in people with Disinfectant Dye Adverse Reaction and Catheter-Related Infections, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Intravenous catheters have become one of the indispensable tools of modern medicine. Peripheric intravenous catheters facilitate the work of healthcare professionals in the treatment phase, especially in diagnostic procedures. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Disinfectant Dye Adverse Reaction, Catheter-Related Infections, Nursing Caries
- What is being tested?
- Skin antisepsis with 5% NaHCO3 water solution and Skin antisepsis with 2% Chlorhexidine Gluconate solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Nov 2017to 27 Jul 2020
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Being between the ages of 1-18
- Having inpatient treatment in pediatric clinics
- No previous history of catheter-related infections
- No history of systemic infection
- Absence of immunological disease
- Not using antibiotherapy
- No scar/scar tissue on the skin in the catheterization area
Who cannot join
- Being an inpatient who does not need intravenous treatment
- Finding an infection
- Having a chronic skin disease
- Having a history of allergies
- Being a newborn
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpaşa
Istanbul, Avcilar, 34320
About this study
Official title: Comparison of the Effects of 5% NaHCO3, 2% Chlorhexidine Gluconate and 70% Alcohol for Prevention of Infections Related to Catheter Applications in Children.
Intravenous catheters have become one of the indispensable tools of modern medicine. Peripheric intravenous catheters facilitate the work of healthcare professionals in the treatment phase, especially in diagnostic procedures. Intravenous catheters cause microorganisms to enter the bloodstream by damaging the skin, which is the body's first defense barrier. In this case, it causes infections, sepsis, an increase in mortality and morbidity rates, prolongation of hospital stay, increase in antibiotic use, and medical expenses. The density of the skin flora in the area where the catheter will be inserted is a major risk factor for infection.To prevent complications associated with peripheric intravenous catheters; Performing the procedure in line with the principles of surgical asepsis and following the correct follow-up are among the most important measures that the nurse should take. Also, the child and the parents should be prepared for the procedure and the appropriate environment should be provided. Along with correct catheter placement and care, antisepsis of the cannula placement area is among the indicators of nursing care.
As well as the effectiveness and safety of skin disinfectants, topical absorption, lack of toxic effect, local and irritation effect are also important. Solutions with 5% NaHCO3 have recently come to the fore as antiseptic agents. When the literature is examined, it has not been found that there are very few studies on this solution and it is used in skin antisepsis before peripheral intravenous catheterization in children. This study was planned as a randomized controlled experimental design to determine the effectiveness of 5% NaHCO3 water solution in catheter site cleaning in pediatric patients by comparing it with the most commonly used antiseptic agents and to monitor the development of catheter-related infections.
Read the detailed description
Intravenous therapy is one of the basic elements of modern health care. IV routes provided through catheters for pediatric patients are necessary for primary and secondary health and increase the possibility of mortality and morbidity depending on the treatment given and the factors of the patient. As in every invasive application, there are problems regarding the use of catheters, which is a minimal surgical procedure, and perhaps the most important of these is catheter-related infections.
CRI's are defined as the accompanying of both local (redness around the catheter, increased temperature, discharge, drainage, tenderness, edema) and systemic (fever, chills, changes in laboratory tests) infection findings in patients and is an important complication for children. is happening. The increase in prevalence varies among patients, as well as between cities and countries, and is among the top three among hospital-associated infections.
Although there are many studies on infections related to the use of a peripheric intravenous catheters in adult patients, it is reported that this issue is not addressed much in children. It is thought that there is no standardization regarding peripheric intravenous catheters management in the studies conducted.
Since the risk factors for infection such as body weight, concomitant chronic disease, characteristics of the catheter used and the drug administered, presence of interconnection for pediatric patients are different from adults, catheter-related infections in the pediatric age group requires a separate discussion. It cannot be denied that the main step in the prevention of catheter-related infections is the management of peripheric intravenous catheters and determining an appropriate skin antiseptic is a part of this.
In Children, 70% Alcohol, 2% Chlorhexidine Gluconate, 1% Octenidine, and 10% Povidone-iodine type antiseptics are commonly used for skin antisepsis. Sodium bicarbonate (NaHCO3) solutions are used in different areas such as oral hygiene and dental care in the world and our country, and side effects are not reported. There is limited information in the literature regarding its use as a skin antiseptic, and it is seen that this information belongs to the adult age group. There is no data on the child age group.
In this study, which was planned in two stages to determine the effectiveness of the use of sodium bicarbonate as a skin antiseptic in the prevention of catheter-related infections, the effectiveness of the antiseptics used in the first stage was evaluated in the laboratory environment against the most common microorganisms in the skin flora, and in the second stage, the use of these antiseptic solutions in skin cleansing in pediatric patients before the peripheric intravenous catheters procedure their effectiveness has been evaluated.
- Conditions
- Disinfectant Dye Adverse Reaction, Catheter-Related Infections, Nursing Caries, Children, Only, Skin Lesion, Chlorhexidine Adverse Reaction
- Being tested
- Skin antisepsis with 5% NaHCO3 water solution, Skin antisepsis with 2% Chlorhexidine Gluconate solution
- Keywords
- Antiseptic, Intravenous catheterization, Catheter-related infection, Chlorhexidine gluconate, Sodium bicarbonate
- Medical subject headings
- Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin antisepsis with 5% NaHCO3 water solutionDrug
Also called Disinfectant drugs, Chemical substance
In-vitro analysis of the solutions was done first. Then solutions were applied, and peripheric intravenous catheter was installed
Skin antisepsis with 2% Chlorhexidine Gluconate solutionDrug
Also called Disinfectant drugs, Chemical substance
In-vitro analysis of the solutions was done first. Then solutions were applied, and peripheric intravenous catheter was installed
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group 1 | Experimental | Cleansing the skin with an antiseptic solution before intravenous catheterization Skin antisepsis with 5% NaHCO3 water solution group Grup number: 20 Receives: Drug: Skin antisepsis with 5% NaHCO3 water solution |
| Experimental Group 2 | Experimental | Cleansing the skin with an antiseptic solution before intravenous catheterization Skin antisepsis with 2% Chlorhexidine Gluconate solution group Grup number: 21 Receives: Drug: Skin antisepsis with 2% Chlorhexidine Gluconate solution |
| Control Group | No intervention | Cleansing the skin with an antiseptic solution before intravenous catheterization Skin antisepsis with 70% Alcohol solution group Grup number: 21 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effectiveness of the solutions - In-vitro analysis
Effectiveness in the laboratory: The efficacy of the solutions on the most common bacteria on the skin was tested in the laboratory.
Analysis of solutions to be used in Laboratory Environment (In vitro): 5% NaHCO3 water solution, 2% KHG solution and 70% Alcohol solution to be used in the catheterization process were studied in the laboratory with the microbiologist in the blood, Müller Hinton agar with disk diffusion method.
The diameter of the discs used is 9 mm. Microorganisms are clinical isolates. As a result, they are the inhibition zones recorded.
Measured: One months
Secondary outcomes (1)
The effectiveness of the solutions - Practice
Before the process, the solutions were prepared by the researcher weekly in the laboratory. The solution to be administered to the patients was determined by randomization.
In the units where the study was conducted, peripheral intravenous catheters were placed in the hospitalized patients who met the inclusion criteria for their routine treatment. Before the procedure, the skin of the catheter insertion site was cleaned with an appropriate antiseptic solution according to the randomization groups.
After skin cleansing, a catheter was inserted. The inserted catheters were fixed with a transparent catheter fixing tape. The introductory information section on the patient in the data collection form was filled in before the procedure, information on catheterization and catheter infection follow-up sections after the insertion of the peripheric intravenous catheter.
Measured: Five months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start7 Nov 2017
- Primary completion27 Jul 2020
- Study completion27 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Disinfectant Dye Adverse ReactionStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blind Randomized controlled Experimental
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysegul Simsek, Istanbul University - Cerrahpasa
- Investigators
- Aysegul Simsek, PhD, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821193
- Sponsor's protocol ID
- Antiseptic
- Status last verified
- Mar 2021
- First submitted
- 18 Mar 2021
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After the study is published in a journal in article format, I can share it.
Publications
Abolfotouh MA, Salam M, Bani-Mustafa A, White D, Balkhy HH. Prospective study of incidence and predictors of peripheral intravenous catheter-induced complications. Ther Clin Risk Manag. 2014 Dec 8;10:993-1001. doi: 10.2147/TCRM.S74685. eCollection 2014.
PubMed 25525365Adams D, Elliot TS. Skin antiseptics used prior to intravascular catheter insertion. Br J Nurs. 2007 Mar 8-21;16(5):278-80. doi: 10.12968/bjon.2007.16.5.22997.
PubMed 17505372Berry AM. A comparison of Listerine(R) and sodium bicarbonate oral cleansing solutions on dental plaque colonisation and incidence of ventilator associated pneumonia in mechanically ventilated patients: a randomised control trial. Intensive Crit Care Nurs. 2013 Oct;29(5):275-81. doi: 10.1016/j.iccn.2013.01.002. Epub 2013 May 19.
PubMed 23692975Bolton D. Improving peripheral cannulation practice at an NHS Trust. Br J Nurs. 2010 Nov 25-Dec 8;19(21):1346, 1348-50. doi: 10.12968/bjon.2010.19.21.79998.
PubMed 21355359Letscher-Bru V, Obszynski CM, Samsoen M, Sabou M, Waller J, Candolfi E. Antifungal activity of sodium bicarbonate against fungal agents causing superficial infections. Mycopathologia. 2013 Feb;175(1-2):153-8. doi: 10.1007/s11046-012-9583-2. Epub 2012 Sep 19.
PubMed 22991095Ding L, Wu HL, Zhu JH, Ding M, Wang YL, Xu XJ. Superiority of 5% NaHCO3 for preoperative hair removal in patients undergoing coronary artery bypass graft surgery with a limb vein: a randomized controlled trialdagger. Eur J Cardiothorac Surg. 2014 Aug;46(2):e28-32. doi: 10.1093/ejcts/ezu203. Epub 2014 Jun 18.
PubMed 24948414Wu HL, Xu YH, Shi JH. 5% NaHCO3 Is Appropriate for Skin Cleaning With Central Venous Catheters. Am J Med Sci. 2017 Jan;353(1):12-16. doi: 10.1016/j.amjms.2016.10.010. Epub 2016 Oct 29.
PubMed 28104097
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of 5% NaHCO3, 2% Chlorhexidine Gluconate and 70% Alcohol for Prevention of Infections Related to Catheter Applications in Children.
- ClinicalTrials.gov ID
- NCT04821193
- Acronym / sponsor ID
- Antiseptic
- Conditions
- Disinfectant Dye Adverse Reaction, Catheter-Related Infections, Nursing Caries, Children, Only, Skin Lesion, Chlorhexidine Adverse Reaction
- Keywords
- Antiseptic, Intravenous catheterization, Catheter-related infection, Chlorhexidine gluconate, Sodium bicarbonate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 27 Jul 2020 (actual)
- Study completion
- 27 Jul 2020 (actual)
- First posted
- 29 Mar 2021 (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.
Intravenous catheters have become one of the indispensable tools of modern medicine. Peripheric intravenous catheters facilitate the work of healthcare professionals in the treatment phase, especially in diagnostic procedures. Intravenous catheters cause microorganisms to enter the bloodstream by damaging the skin, which is the body's first defense barrier. In this case, it causes infections, sepsis, an increase in mortality and morbidity rates, prolongation of hospital stay, increase in antibiotic use, and medical expenses. The density of the skin flora in the area where the catheter will be inserted is a major risk factor for infection.To prevent complications associated with peripheric intravenous catheters; Performing the procedure in line with the principles of surgical asepsis and following the correct follow-up are among the most important measures that the nurse should take. Also, the child and the parents should be prepared for the procedure and the appropriate environment should be provided. Along with correct catheter placement and care, antisepsis of the cannula placement area is among the indicators of nursing care.
As well as the effectiveness and safety of skin disinfectants, topical absorption, lack of toxic effect, local and irritation effect are also important. Solutions with 5% NaHCO3 have recently come to the fore as antiseptic agents. When the literature is examined, it has not been found that there are very few studies on this solution and it is used in skin antisepsis before peripheral intravenous catheterization in children. This study was planned as a randomized controlled experimental design to determine the effectiveness of 5% NaHCO3 water solution in catheter site cleaning in pediatric patients by comparing it with the most commonly used antiseptic agents and to monitor the development of catheter-related infections.
Detailed description
Intravenous therapy is one of the basic elements of modern health care. IV routes provided through catheters for pediatric patients are necessary for primary and secondary health and increase the possibility of mortality and morbidity depending on the treatment given and the factors of the patient. As in every invasive application, there are problems regarding the use of catheters, which is a minimal surgical procedure, and perhaps the most important of these is catheter-related infections.
CRI's are defined as the accompanying of both local (redness around the catheter, increased temperature, discharge, drainage, tenderness, edema) and systemic (fever, chills, changes in laboratory tests) infection findings in patients and is an important complication for children. is happening. The increase in prevalence varies among patients, as well as between cities and countries, and is among the top three among hospital-associated infections.
Although there are many studies on infections related to the use of a peripheric intravenous catheters in adult patients, it is reported that this issue is not addressed much in children. It is thought that there is no standardization regarding peripheric intravenous catheters management in the studies conducted.
Since the risk factors for infection such as body weight, concomitant chronic disease, characteristics of the catheter used and the drug administered, presence of interconnection for pediatric patients are different from adults, catheter-related infections in the pediatric age group requires a separate discussion. It cannot be denied that the main step in the prevention of catheter-related infections is the management of peripheric intravenous catheters and determining an appropriate skin antiseptic is a part of this.
In Children, 70% Alcohol, 2% Chlorhexidine Gluconate, 1% Octenidine, and 10% Povidone-iodine type antiseptics are commonly used for skin antisepsis. Sodium bicarbonate (NaHCO3) solutions are used in different areas such as oral hygiene and dental care in the world and our country, and side effects are not reported. There is limited information in the literature regarding its use as a skin antiseptic, and it is seen that this information belongs to the adult age group. There is no data on the child age group.
In this study, which was planned in two stages to determine the effectiveness of the use of sodium bicarbonate as a skin antiseptic in the prevention of catheter-related infections, the effectiveness of the antiseptics used in the first stage was evaluated in the laboratory environment against the most common microorganisms in the skin flora, and in the second stage, the use of these antiseptic solutions in skin cleansing in pediatric patients before the peripheric intravenous catheters procedure their effectiveness has been evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Single blind Randomized controlled Experimental
| Arm | Type | Receives |
|---|---|---|
| Experimental Group 1 | Experimental | Drug: Skin antisepsis with 5% NaHCO3 water solutionCleansing the skin with an antiseptic solution before intravenous catheterization Skin antisepsis with 5% NaHCO3 water solution group Grup number: 20 |
| Experimental Group 2 | Experimental | Drug: Skin antisepsis with 2% Chlorhexidine Gluconate solutionCleansing the skin with an antiseptic solution before intravenous catheterization Skin antisepsis with 2% Chlorhexidine Gluconate solution group Grup number: 21 |
| Control Group | No intervention | –Cleansing the skin with an antiseptic solution before intravenous catheterization Skin antisepsis with 70% Alcohol solution group Grup number: 21 |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Being between the ages of 1-18
- Having inpatient treatment in pediatric clinics
- No previous history of catheter-related infections
- No history of systemic infection
- Absence of immunological disease
Key exclusion criteria (5 listed)
- Being an inpatient who does not need intravenous treatment
- Finding an infection
- Having a chronic skin disease
- Having a history of allergies
- Being a newborn
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 |
|---|---|---|
| Skin antisepsis with 5% NaHCO3 water solutionAlso: Disinfectant drugs, Chemical substanceIn-vitro analysis of the solutions was done first. Then solutions were applied, and peripheric intravenous catheter was installed | Drug | Experimental Group 1 |
| Skin antisepsis with 2% Chlorhexidine Gluconate solutionAlso: Disinfectant drugs, Chemical substanceIn-vitro analysis of the solutions was done first. Then solutions were applied, and peripheric intravenous catheter was installed | Drug | Experimental Group 2 |
Primary outcome
The effectiveness of the solutions - In-vitro analysis
Time frame: One months
Effectiveness in the laboratory: The efficacy of the solutions on the most common bacteria on the skin was tested in the laboratory. Analysis of solutions to be used in Laboratory Environment (In vitro): 5% NaHCO3 water solution, 2% KHG solution and 70% Alcohol solution to be used in the catheterization process were studied in the laboratory with the microbiologist in the blood, Müller Hinton agar with disk diffusion method. The diameter of the discs used is 9 mm. Microorganisms are clinical isolates. As a result, they are the inhibition zones recorded.
1 secondary outcome
The effectiveness of the solutions - Practice
Time frame: Five months
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 29 Mar 2021.
- Background: PubMed 25525365Abolfotouh MA, Salam M, Bani-Mustafa A, White D, Balkhy HH. Prospective study of incidence and predictors of peripheral intravenous catheter-induced complications. Ther Clin Risk Manag. 2014 Dec 8;10:993-1001. doi: 10.2147/TCRM.S74685. eCollection 2014.
- Background: PubMed 17505372Adams D, Elliot TS. Skin antiseptics used prior to intravascular catheter insertion. Br J Nurs. 2007 Mar 8-21;16(5):278-80. doi: 10.12968/bjon.2007.16.5.22997.
- Background: PubMed 23692975Berry AM. A comparison of Listerine(R) and sodium bicarbonate oral cleansing solutions on dental plaque colonisation and incidence of ventilator associated pneumonia in mechanically ventilated patients: a randomised control trial. Intensive Crit Care Nurs. 2013 Oct;29(5):275-81. doi: 10.1016/j.iccn.2013.01.002. Epub 2013 May 19.
- Background: PubMed 21355359Bolton D. Improving peripheral cannulation practice at an NHS Trust. Br J Nurs. 2010 Nov 25-Dec 8;19(21):1346, 1348-50. doi: 10.12968/bjon.2010.19.21.79998.
- Background: PubMed 22991095Letscher-Bru V, Obszynski CM, Samsoen M, Sabou M, Waller J, Candolfi E. Antifungal activity of sodium bicarbonate against fungal agents causing superficial infections. Mycopathologia. 2013 Feb;175(1-2):153-8. doi: 10.1007/s11046-012-9583-2. Epub 2012 Sep 19.
- Background: PubMed 24948414Ding L, Wu HL, Zhu JH, Ding M, Wang YL, Xu XJ. Superiority of 5% NaHCO3 for preoperative hair removal in patients undergoing coronary artery bypass graft surgery with a limb vein: a randomized controlled trialdagger. Eur J Cardiothorac Surg. 2014 Aug;46(2):e28-32. doi: 10.1093/ejcts/ezu203. Epub 2014 Jun 18.
- Background: PubMed 28104097Wu HL, Xu YH, Shi JH. 5% NaHCO3 Is Appropriate for Skin Cleaning With Central Venous Catheters. Am J Med Sci. 2017 Jan;353(1):12-16. doi: 10.1016/j.amjms.2016.10.010. Epub 2016 Oct 29.
- Adıgüzel, Ö. (2015). Klorheksidin. Turkiye Klinikleri J Endod-Special Topics, 1(2), 15-9.Link provided by the sponsor.
- Aktaş, E., Sarı, E.N., Seremet Keskin, A., Pişkin, N., Külah, C., Cömert, F. (2011) Damar İçi Kateter ile İlişkili Enfeksiyon Etkenleri ve Antibiyotik Duyarlılıkları. Mikrobiyoloji Bülteni, 45(1), 86-92.Link provided by the sponsor.
- Individual participant dataSharing planned: No. After the study is published in a journal in article format, I can share it.
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.
Aysegul Simsek, PhD study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin antisepsis with 5% NaHCO3 water solution and Skin antisepsis with 2% Chlorhexidine Gluconate solution in people with Disinfectant Dye Adverse Reaction and Catheter-Related Infections, run by Istanbul University - Cerrahpasa 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 7 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 29 Mar 2021. 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?
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?
The effectiveness of the solutions - In-vitro analysis (time frame: One months). 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 NCT04821193, which also lists 7 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 29 Mar 2021.