Laceration - InjuryION-SiLacNCT02976480
The Irrigation or No Irrigation in Simple Lacerations Trials
A study testing Irrigation and No irrigation in people with Laceration - Injury and Infection, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether the irrigation or non-irrigation of a simple laceration treated in the emergency department has an effect on the subsequent rate of infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laceration - Injury, Infection
- What is being tested?
- Irrigation and No irrigation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2017to 22 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- age 18 or older
- repair within 18 hours from time of injury
- repair done by the emergency room physician or trainee
- clean and simple lacerations (clean edge with no gross contamination, as assessed by the treating physician)
Who cannot join
- pregnant patients
- involving tendons, muscles, fascias, articulations
- located on the ear, nose or distal to metacarpophalangeal or metatarsophalangeal joint
- immunosuppressed (neutropenia, chronic corticotherapy, HIV, immunosuppressive therapy within 3 months)
- bite wounds
- lacerations with any loss of substance
Show all 9Show fewer
- lacerations with foreign body
- complex lacerations (crush, stellate)
- grossly contaminated
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
CIUSSS Saguenay-Lac-St-Jean, Hôpital de Chicoutimi
Chicoutimi, Quebec, G7H5H6
Julien Bouchard, MD, CCFP(EM), 418-541-1000, julien.bouchard@usherbrooke.ca
Antoine Herman-Lemelin, MD, CCFP(EM)
About this study
The purpose of this study is to determine whether the irrigation or non-irrigation of a simple laceration treated in the emergency department has an effect on the subsequent rate of infection.
Read the detailed description
Background: Current guidelines recommend that lacerations be irrigated prior to their closure. However, there is very little data in the literature suggesting that simple laceration irrigation diminishes the subsequent rate of infection. Do patients benefit from this practice that involves additional time and costs?
Hypothesis Testing \& Procedure: The purpose of this double-blind randomized controlled non-inferiority study is to test the hypothesis that the non-irrigation of lacerations does not increase the rate of post-repair infection. Every adult patients presenting to the Chicoutimi's Hospital Emergency Department with a simple laceration will be identify by the triage nurse. Eligibility will subsequently be assessed by the emergency room physician according to the inclusion and exclusion criteria. Eligible and consenting patients will be randomized to either the irrigation or non-irrigation arm. Post-repair rate of infection and aesthetic appearance satisfaction will be reported.
Sample Size Determination: With the fairly liberal inclusion criteria, a 6% wound infection rate in the irrigation group is expected, which corresponds to the upper limit of the 2 to 6% range reported in the literature. Non-inferiority of non-irrigation would be accepted if the rate of infection in this group does not exceed by 4% the usual infection rate of 6% with irrigation, as previously stated. As such, for the study to be powered at 80% with a 95% one-sided confidence interval, a population of 874 patients would be needed to conclude that the non-irrigation is non-inferior when its infection rate does not exceed by more than 4% the infection rate of the irrigation group. In addition, to account for an attrition rate of approximately 10%, enrolment of 1000 patients is aimed.
Statistical Analysis: Statistical analysis will be done by a certified statistician. According to the distribution of our data, the Chi2 or the Fisher test will be used. A preliminary analysis of our data will be done in the Spring 2017 to assess safety of our intervention.
Plan for Missing Data: Patients that are lost at follow up will be considered as having had no infection if no record of subsequent visits for wound infection is found after consultation of the regional Electronic Medical Record.
- Conditions
- Laceration - Injury, Infection
- Being tested
- Irrigation, No irrigation
- Keywords
- Irrigation
- Medical subject headings
- Lacerations, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrrigationProcedure or surgery
A designated unblinded medical team member (nurse, emergency room physician or resident/trainee uninvolved in that particular patient's care) will prepare the laceration for repair and perform the irrigation. Irrigation will be delivered through a 20 Gauge 1 inch long catheter mounted on a 60 millilitre syringe. The volume of normal saline used will be calculated as 60 millilitre per centimetre length of laceration for a maximum of 300 millilitre. Once completed, the treating physician will enter the room and proceed to the laceration closure with the method and equipment of his choice. Both the patient (through eye covering) and the treating physician will remain blinded to the intervention.
No irrigationProcedure or surgery
A designated unblinded medical team member (nurse, emergency room physician or resident/trainee uninvolved in that particular patient's care) will prepare the laceration for repair. The laceration will not directly be irrigated. In order to ensure blinding of the subjects, the surrounding of the wound will be irrigated with a total of 60 millilitre of normal saline delivered through a 20 Gauge 1 inch long catheter mounted on a 60 millilitre syringe. Care will be taken not to enter a margin of 5cm from the laceration edges. Once completed, the treating physician will enter the room and proceed to the laceration closure with the method and equipment of his choice. Both the patient (through eye covering) and the treating physician will remain blinded to the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Irrigation | Active comparator | The subjects randomized to this group will have their simple lacerations irrigated with a normal saline solution. Receives: Procedure: Irrigation |
| No Irrigation | Experimental | The subjects randomized to this group will not have their simple lacerations directly irrigated with a normal saline solution. Receives: Procedure: No irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laceration infection following repair
The primary outcome measured will be the 30-day post-repair infection rate in both study groups.
At 30 days post-repair, patients will be contacted by phone by a trained nurse. A standardized form will be used to collect relevant information. Patients will be asked whether they consulted a physician for a wound infection, and if antibiotics or drainage was required. An infected wound is defined as one requiring either drainage or antibiotic treatment by the assessing physician.
The regional Medical Electronic Record will be reviewed for patients that were lost at follow up. Records of subsequent visits for wound infection will be looked for at 30 days post-repair.
Measured: At 30 days post-repair
Secondary outcomes (2)
Laceration infections following repair
The wounds of enrolled subjects will systematically be evaluated by a nurse between 5 to 10 days post-repair. A standardized form will be used by the nurse to identify criteria of possible wound infection (erythema, purulence, induration, fever, pain, fluctuance, dehiscence). A wound suspected to be infected by the presence of any of the previous criteria will immediately be evaluated by an emergency room physician to adjudicate on its infection status. An infected wound is defined as one requiring either drainage or antibiotic treatment based on the judgement of the physician.
The regional Medical Electronic Record will be reviewed for patients that were lost at follow up. Records of subsequent visits for wound infection will be looked for at 30 days post-repair.
Measured: At 5 to 10 days post-repair
Aesthetic appearance of the laceration following repair
The following question will be asked:
"Considering the appearance and localisation of the laceration before repair, considering that complete healing of the laceration could take up to a year duration, and considering that sun exposure needs to be avoided during the healing period, are you satisfied with the appearance your laceration has today?" Yes or No.
Measured: At 30 days post-repair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionFeb 2025 (estimated)
- Study completion22 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Laceration - InjuryStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Agence de la Sante et des Services Sociaux du Saguenay-Lac-Saint-Jean
- Responsible party
- Principal investigator, Julien Bouchard, Université de Sherbrooke
- Investigators
- Julien Bouchard, MD, CCFP(EM), Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976480
- Sponsor's protocol ID
- 2016-025
- Acronym
- ION-SiLac
- Status last verified
- Feb 2025
- First submitted
- 3 Nov 2016
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Dire DJ, Welsh AP. A comparison of wound irrigation solutions used in the emergency department. Ann Emerg Med. 1990 Jun;19(6):704-8. doi: 10.1016/s0196-0644(05)82484-9.
PubMed 2344089Moscati R, Mayrose J, Fincher L, Jehle D. Comparison of normal saline with tap water for wound irrigation. Am J Emerg Med. 1998 Jul;16(4):379-81. doi: 10.1016/s0735-6757(98)90133-4.
PubMed 9672456Moscati RM, Mayrose J, Reardon RF, Janicke DM, Jehle DV. A multicenter comparison of tap water versus sterile saline for wound irrigation. Acad Emerg Med. 2007 May;14(5):404-9. doi: 10.1197/j.aem.2007.01.007.
PubMed 17456554Griffiths RD, Fernandez RS, Ussia CA. Is tap water a safe alternative to normal saline for wound irrigation in the community setting? J Wound Care. 2001 Nov;10(10):407-11. doi: 10.12968/jowc.2001.10.10.26149.
PubMed 12964289Bansal BC, Wiebe RA, Perkins SD, Abramo TJ. Tap water for irrigation of lacerations. Am J Emerg Med. 2002 Sep;20(5):469-72. doi: 10.1053/ajem.2002.35501.
PubMed 12216046Valente JH, Forti RJ, Freundlich LF, Zandieh SO, Crain EF. Wound irrigation in children: saline solution or tap water? Ann Emerg Med. 2003 May;41(5):609-16. doi: 10.1067/mem.2003.137.
PubMed 12712026Fernandez R, Griffiths R. Water for wound cleansing. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD003861. doi: 10.1002/14651858.CD003861.pub3.
PubMed 22336796Stevenson TR, Thacker JG, Rodeheaver GT, Bacchetta C, Edgerton MT, Edlich RF. Cleansing the traumatic wound by high pressure syringe irrigation. JACEP. 1976 Jan;5(1):17-21. doi: 10.1016/s0361-1124(76)80160-8.
PubMed 933383Hollander JE, Richman PB, Werblud M, Miller T, Huggler J, Singer AJ. Irrigation in facial and scalp lacerations: does it alter outcome? Ann Emerg Med. 1998 Jan;31(1):73-7. doi: 10.1016/s0196-0644(98)70284-7.
PubMed 9437345Hollander JE, Singer AJ, Valentine S. Comparison of wound care practices in pediatric and adult lacerations repaired in the emergency department. Pediatr Emerg Care. 1998 Feb;14(1):15-8. doi: 10.1097/00006565-199802000-00004.
PubMed 9516624Maharaj D, Sharma D, Ramdass M, Naraynsingh V. Closure of traumatic wounds without cleaning and suturing. Postgrad Med J. 2002 May;78(919):281-2. doi: 10.1136/pmj.78.919.281.
PubMed 12151570Webster DJ, Davis PW. Closure of abdominal wounds by adhesive strips: a clinical trial. Br Med J. 1975 Sep 20;3(5985):696-8. doi: 10.1136/bmj.3.5985.696.
PubMed 1100188Rodeheaver GT, Pettry D, Thacker JG, Edgerton MT, Edlich RF. Wound cleansing by high pressure irrigation. Surg Gynecol Obstet. 1975 Sep;141(3):357-62.
PubMed 808870Longmire AW, Broom LA, Burch J. Wound infection following high-pressure syringe and needle irrigation. Am J Emerg Med. 1987 Mar;5(2):179-81. doi: 10.1016/0735-6757(87)90121-5. No abstract available.
PubMed 3828025Pronchik D, Barber C, Rittenhouse S. Low- versus high-pressure irrigation techniques in Staphylococcus aureus-inoculated wounds. Am J Emerg Med. 1999 Mar;17(2):121-4. doi: 10.1016/s0735-6757(99)90041-4.
PubMed 10102307
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Irrigation or No Irrigation in Simple Lacerations Trials
- ClinicalTrials.gov ID
- NCT02976480
- Acronym / sponsor ID
- ION-SiLac / 2016-025
- Conditions
- Laceration - Injury, Infection
- Keywords
- Irrigation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Agence de la Sante et des Services Sociaux du Saguenay-Lac-Saint-Jean
- Study start
- Jan 2017 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- 22 Feb 2025 (estimated)
- First posted
- 29 Nov 2016 (estimated)
- 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.
The purpose of this study is to determine whether the irrigation or non-irrigation of a simple laceration treated in the emergency department has an effect on the subsequent rate of infection.
Detailed description
Background: Current guidelines recommend that lacerations be irrigated prior to their closure. However, there is very little data in the literature suggesting that simple laceration irrigation diminishes the subsequent rate of infection. Do patients benefit from this practice that involves additional time and costs?
Hypothesis Testing \& Procedure: The purpose of this double-blind randomized controlled non-inferiority study is to test the hypothesis that the non-irrigation of lacerations does not increase the rate of post-repair infection. Every adult patients presenting to the Chicoutimi's Hospital Emergency Department with a simple laceration will be identify by the triage nurse. Eligibility will subsequently be assessed by the emergency room physician according to the inclusion and exclusion criteria. Eligible and consenting patients will be randomized to either the irrigation or non-irrigation arm. Post-repair rate of infection and aesthetic appearance satisfaction will be reported.
Sample Size Determination: With the fairly liberal inclusion criteria, a 6% wound infection rate in the irrigation group is expected, which corresponds to the upper limit of the 2 to 6% range reported in the literature. Non-inferiority of non-irrigation would be accepted if the rate of infection in this group does not exceed by 4% the usual infection rate of 6% with irrigation, as previously stated. As such, for the study to be powered at 80% with a 95% one-sided confidence interval, a population of 874 patients would be needed to conclude that the non-irrigation is non-inferior when its infection rate does not exceed by more than 4% the infection rate of the irrigation group. In addition, to account for an attrition rate of approximately 10%, enrolment of 1000 patients is aimed.
Statistical Analysis: Statistical analysis will be done by a certified statistician. According to the distribution of our data, the Chi2 or the Fisher test will be used. A preliminary analysis of our data will be done in the Spring 2017 to assess safety of our intervention.
Plan for Missing Data: Patients that are lost at follow up will be considered as having had no infection if no record of subsequent visits for wound infection is found after consultation of the regional Electronic Medical Record.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irrigation | Active comparator | Procedure: IrrigationThe subjects randomized to this group will have their simple lacerations irrigated with a normal saline solution. |
| No Irrigation | Experimental | Procedure: No irrigationThe subjects randomized to this group will not have their simple lacerations directly irrigated with a normal saline solution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 or older
- repair within 18 hours from time of injury
- repair done by the emergency room physician or trainee
- clean and simple lacerations (clean edge with no gross contamination, as assessed by the treating physician)
Key exclusion criteria (9 listed)
- pregnant patients
- involving tendons, muscles, fascias, articulations
- located on the ear, nose or distal to metacarpophalangeal or metatarsophalangeal joint
- immunosuppressed (neutropenia, chronic corticotherapy, HIV, immunosuppressive therapy within 3 months)
- bite wounds
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 |
|---|---|---|
| IrrigationA designated unblinded medical team member (nurse, emergency room physician or resident/trainee uninvolved in that particular patient's care) will prepare the laceration for repair and perform the irrigation. Irrigation will be delivered through a 20 Gauge 1 inch long catheter mounted on a 60 millilitre syringe. The volume of normal saline used will be calculated as 60 millilitre per centimetre length of laceration for a maximum of 300 millilitre. Once completed, the treating physician will enter the room and proceed to the laceration closure with the method and equipment of his choice. Both the patient (through eye covering) and the treating physician will remain blinded to the intervention. | Procedure or surgery | Irrigation |
| No irrigationA designated unblinded medical team member (nurse, emergency room physician or resident/trainee uninvolved in that particular patient's care) will prepare the laceration for repair. The laceration will not directly be irrigated. In order to ensure blinding of the subjects, the surrounding of the wound will be irrigated with a total of 60 millilitre of normal saline delivered through a 20 Gauge 1 inch long catheter mounted on a 60 millilitre syringe. Care will be taken not to enter a margin of 5cm from the laceration edges. Once completed, the treating physician will enter the room and proceed to the laceration closure with the method and equipment of his choice. Both the patient (through eye covering) and the treating physician will remain blinded to the intervention. | Procedure or surgery | No Irrigation |
Primary outcome
Laceration infection following repair
Time frame: At 30 days post-repair
The primary outcome measured will be the 30-day post-repair infection rate in both study groups. At 30 days post-repair, patients will be contacted by phone by a trained nurse. A standardized form will be used to collect relevant information. Patients will be asked whether they consulted a physician for a wound infection, and if antibiotics or drainage was required. An infected wound is defined as one requiring either drainage or antibiotic treatment by the assessing physician. The regional Medical Electronic Record will be reviewed for patients that were lost at follow up. Records of subsequent visits for wound infection will be looked for at 30 days post-repair.
2 secondary outcomes
Laceration infections following repair
Time frame: At 5 to 10 days post-repair
Aesthetic appearance of the laceration following repair
Time frame: At 30 days post-repair
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Background: PubMed 2344089Dire DJ, Welsh AP. A comparison of wound irrigation solutions used in the emergency department. Ann Emerg Med. 1990 Jun;19(6):704-8. doi: 10.1016/s0196-0644(05)82484-9.
- Background: PubMed 9672456Moscati R, Mayrose J, Fincher L, Jehle D. Comparison of normal saline with tap water for wound irrigation. Am J Emerg Med. 1998 Jul;16(4):379-81. doi: 10.1016/s0735-6757(98)90133-4.
- Background: PubMed 17456554Moscati RM, Mayrose J, Reardon RF, Janicke DM, Jehle DV. A multicenter comparison of tap water versus sterile saline for wound irrigation. Acad Emerg Med. 2007 May;14(5):404-9. doi: 10.1197/j.aem.2007.01.007.
- Background: PubMed 12964289Griffiths RD, Fernandez RS, Ussia CA. Is tap water a safe alternative to normal saline for wound irrigation in the community setting? J Wound Care. 2001 Nov;10(10):407-11. doi: 10.12968/jowc.2001.10.10.26149.
- Background: PubMed 12216046Bansal BC, Wiebe RA, Perkins SD, Abramo TJ. Tap water for irrigation of lacerations. Am J Emerg Med. 2002 Sep;20(5):469-72. doi: 10.1053/ajem.2002.35501.
- Background: PubMed 12712026Valente JH, Forti RJ, Freundlich LF, Zandieh SO, Crain EF. Wound irrigation in children: saline solution or tap water? Ann Emerg Med. 2003 May;41(5):609-16. doi: 10.1067/mem.2003.137.
- Background: PubMed 22336796Fernandez R, Griffiths R. Water for wound cleansing. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD003861. doi: 10.1002/14651858.CD003861.pub3.
- Background: PubMed 933383Stevenson TR, Thacker JG, Rodeheaver GT, Bacchetta C, Edgerton MT, Edlich RF. Cleansing the traumatic wound by high pressure syringe irrigation. JACEP. 1976 Jan;5(1):17-21. doi: 10.1016/s0361-1124(76)80160-8.
- Background: PubMed 9437345Hollander JE, Richman PB, Werblud M, Miller T, Huggler J, Singer AJ. Irrigation in facial and scalp lacerations: does it alter outcome? Ann Emerg Med. 1998 Jan;31(1):73-7. doi: 10.1016/s0196-0644(98)70284-7.
- Background: PubMed 9516624Hollander JE, Singer AJ, Valentine S. Comparison of wound care practices in pediatric and adult lacerations repaired in the emergency department. Pediatr Emerg Care. 1998 Feb;14(1):15-8. doi: 10.1097/00006565-199802000-00004.
- Background: PubMed 12151570Maharaj D, Sharma D, Ramdass M, Naraynsingh V. Closure of traumatic wounds without cleaning and suturing. Postgrad Med J. 2002 May;78(919):281-2. doi: 10.1136/pmj.78.919.281.
- Background: PubMed 1100188Webster DJ, Davis PW. Closure of abdominal wounds by adhesive strips: a clinical trial. Br Med J. 1975 Sep 20;3(5985):696-8. doi: 10.1136/bmj.3.5985.696.
- Individual participant dataSharing planned: Yes
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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.
Julien Bouchard, MD, CCFP(EM) principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irrigation and No irrigation in people with Laceration - Injury and Infection, run by Université de Sherbrooke at 1 site in Canada.
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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 25 Feb 2025. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julien Bouchard, MD, CCFP(EM) (418-541-1000, julien.bouchard@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laceration infection following repair (time frame: At 30 days post-repair). 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 NCT02976480, which also lists 18 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 25 Feb 2025.