Surgical Wound DehiscenceSUTURANCT06501508
Abdominal Wall Dehiscence After Laparotomy Closure in Abdominal Surgery: a Retrospective Observational Study on the Influence of the Suture Used
An observational study of Surgical Wound Dehiscence, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 4 sites in Spain.
Trial summary
In this retrospective longitudinal observational study we compare the incidence of fascial dehiscence and incisional hernia in patients operated via abdominal wall incision, comparing the barbed suture Stratafix Symmetric to other types of suture during closure of the abdominal wall. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound Dehiscence
- What is being tested?
- Stratafix Symmetric
- Type of treatment
- Medical device
- How many people
- 1,900 participants
- Where
- 4 sitesSpain
- Study dates
- 22 Nov 2023to 22 Nov 2024
- Phase
- Observational
- 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
Study population: All adults over 18 years of age operated via laparotomy or laparoscopy with extraction site incision in the 4 participating Hospitals between 01/01/2018 and 21/11/23
Who may be able to join
- Age over 18 years, abdominal incision or laparoscopy with extraction site incision
Who cannot join
- Pregnancy, use of mesh for fascial closure in primary surgery, history of ventral abdominal hernia surgery
Trial locations and contacts
4 sites in 1 country.
Marius Kaser, Dr. contact
Spain4 sites, 4 recruiting
- Recruiting
Hospital universitario General de Villalba
Collado Villalba, Madrid, 28400
Hector Guadalajara Labajo, 0034649429243
María José Fraile Vilarrasa
- Recruiting
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Hector Guadalajara Labajo, 0034694429243, h.guadalajara@quironsalud.es
Marius Kaeser, 0034652174951, marius.kaser@quironsalud.es
- Recruiting
Hospital Universitario Rey Juan Carlos
Madrid, 28933
Hector Guadalajara, 0034649429243
Maria Belen Manso Abajo
- Recruiting
Hospital Universitario Infanta Elena
Valdemoro, Madrid, 28342
Hecotr Guadalajara Labajo
Santos Jiménez de los Galanes
About this study
In this retrospective longitudinal observational study we compare the incidence of fascial dehiscence and incisional hernia in patients operated via abdominal wall incision, comparing the barbed suture Stratafix Symmetric to other types of suture during closure of the abdominal wall. In addition, we plan to analize the impact of other risk factors, patient related and patient unrelated, on the incidence of fascial dehiscence.
Read the detailed description
In this retrospective longitudinal observational study we primarily aim to compare the influence of the applied suture type (Stratafix Symmetric versus other suture types) for primary fascial closure in abdominal surgery on the incidence of fascial dehiscence.
Secondary outcomes such as will also be analized. Primary outcomeis the incidence of abdominal wall dehiscence. Secondary outcomes are the impact of the occurrence of abdominal wall dehiscence on mortality and hospital stay, the influence of other risk factors on the occurrence of abdominal wall dehiscence, the influence of the suture type and other risk factors on the incidence of incisional hernia after 12 months of follow-up and a speciality subgroup analysis.
The diagnoses of each patient and the procedures performed are coded according to ICD 9 or ICD 10. For primary cause diagnoses and secondary diagnoses, external causes and procedures, ICD9/ICD10 codes are also used. Following the AHQR definition, cases of laparotomy dehiscence will be defined as those whose ICD 9/ICD 10 codes conform to "New closure of postoperative abdominal wall disruption", as well as those identified secondarily after crossing the databases as reoperated for this reason with another coding.
Statistical analysis will be performed using statistical techniques appropriate to the variables under study. A descriptive analysis of the population will be performed, frequency results will be expressed in absolute terms, such as percentages and confidence intervals. The percentage of subjects with dehiscence will be calculated by the group. A two-sided 95% confidence interval (CI) for the difference in percentages (Stratafix - Control) will be estimated using the Wald method. If the upper limit of the confidence interval for the difference in percentages (Stratafix-Control) is below 0, then it will be concluded that the true dehiscence rate for Stratafix is lower than that for the control. In addition, two-sided 95% CIs within each group will be estimated for the dehiscence rate using the Clopper-Pearson method.
Continuous variables will be expressed as mean (SD) and median (range) according to the normality test (Kolmogorov Smirnov test). For the study of the relationship between the different variables, Chi-square or Analysis of Variance will be used if they are parametric. And if they do not follow a normal distribution, nonparametric tests will be used (Mann-Whitney U or Kruskal Wallis, as appropriate). Biochemical recurrence-free survival (BCR-free survival) will be estimated using Kaplan-Meier curves. SPSS. 21 (SPSS Inc. Chicago, IL, USA) will be used.
- Conditions
- Surgical Wound Dehiscence
- Being tested
- Stratafix Symmetric
- Medical subject headings
- Surgical Wound Dehiscence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stratafix SymmetricDevice
Use of Stratafix Symmetric for primary fascial closure
| Study group | Role | What they receive |
|---|---|---|
| Stratafix | All patients in which Stratafix symmetric was used for the primary closure of the abdominal wall incision Receives: Device: Stratafix Symmetric | |
| Control | All patients in which other, conventional suture types were used for primary closure of the abdominal wall incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal Wall Dehiscence
Disruption of all layers of the abdominal wall with exposure of abdominal viscera within 30 days after primary surgery
Measured: 30 days
Secondary outcomes (8)
Incisional hernia
Any defect of the abdominal wall in the area of the primary incision, palpable or visible in ultrasound, CT- or MR-Scan, with or without protrusion of intraabdominal content
Measured: 1 year
PROMs - Postoperative Pain
One question about pain - 4 answers
Measured: 1 year
PROMs - Mental and emotional health
Two questions - 4 answers for each question
Measured: 1 year
PROMs - Work an social life performance
Two questions - 4 answers for each question
Measured: 1 year
PROMs - Fatigue
Two questions - 4 answers for each question
Measured: 1 year
PROMs - Funcionality
One question - 4 answers for each question
Measured: 1 year
PROMs - Sexuality
One question - 4 answers for each question
Measured: 1 year
PROMs - Body image
One question - 4 answers for each question
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start22 Nov 2023
- Primary completion22 Nov 2024 (estimated)
- Study completion22 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Surgical Wound DehiscenceStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon, Inc.
- Responsible party
- Sponsor
- Investigators
- Hector Gauadalajara Labajo, PHD, Principal investigator, Quironsalud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501508
- Sponsor's protocol ID
- PIC089-23_FJD
- Acronym
- SUTURA
- Status last verified
- Nov 2023
- First submitted
- 22 Nov 2023
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Zolin SJ, Rosen MJ. Failure of Abdominal Wall Closure: Prevention and Management. Surg Clin North Am. 2021 Oct;101(5):875-888. doi: 10.1016/j.suc.2021.07.001.
PubMed 34537149Rodriguez-Hermosa JI, Codina-Cazador A, Ruiz B, Roig J, Girones J, Pujadas M, Pont J, Aldeguer X, Acero D. [Risk factors for acute abdominal wall dehiscence after laparotomy in adults]. Cir Esp. 2005 May;77(5):280-6. doi: 10.1016/s0009-739x(05)70854-x. Spanish.
PubMed 16420934Gili-Ortiz E, Gonzalez-Guerrero R, Bejar-Prado L, Ramirez-Ramirez G, Lopez-Mendez J. [Postoperative dehiscence of the abdominal wound and its impact on excess mortality, hospital stay and costs]. Cir Esp. 2015 Aug-Sep;93(7):444-9. doi: 10.1016/j.ciresp.2015.02.005. Epub 2015 May 6. Spanish.
PubMed 25956459Jensen KK, Oma E, van Ramshorst GH, Nordholm-Carstensen A, Krarup PM. Abdominal wound dehiscence is dangerous: a nationwide study of 14,169 patients undergoing elective open resection for colonic cancer. Hernia. 2022 Feb;26(1):75-86. doi: 10.1007/s10029-020-02350-z. Epub 2021 Jan 4.
PubMed 33394254Farquhar M. AHRQ Quality Indicators. In: Hughes RG, editor. Patient Safety and Quality: An Evidence-Based Handbook for Nurses. Rockville (MD): Agency for Healthcare Research and Quality (US); 2008 Apr. Chapter 45. Available from http://www.ncbi.nlm.nih.gov/books/NBK2664/
PubMed 21328764Zucker BE, Simillis C, Tekkis P, Kontovounisios C. Suture choice to reduce occurrence of surgical site infection, hernia, wound dehiscence and sinus/fistula: a network meta-analysis. Ann R Coll Surg Engl. 2019 Mar;101(3):150-161. doi: 10.1308/rcsann.2018.0170. Epub 2018 Oct 5.
PubMed 30286645Jenkins TP. The burst abdominal wound: a mechanical approach. Br J Surg. 1976 Nov;63(11):873-6. doi: 10.1002/bjs.1800631110.
PubMed 137024Henriksen NA, Deerenberg EB, Venclauskas L, Fortelny RH, Miserez M, Muysoms FE. Meta-analysis on Materials and Techniques for Laparotomy Closure: The MATCH Review. World J Surg. 2018 Jun;42(6):1666-1678. doi: 10.1007/s00268-017-4393-9.
PubMed 29322212Patel SV, Paskar DD, Nelson RL, Vedula SS, Steele SR. Closure methods for laparotomy incisions for preventing incisional hernias and other wound complications. Cochrane Database Syst Rev. 2017 Nov 3;11(11):CD005661. doi: 10.1002/14651858.CD005661.pub2.
PubMed 29099149Cengiz Y, Blomquist P, Israelsson LA. Small tissue bites and wound strength: an experimental study. Arch Surg. 2001 Mar;136(3):272-5. doi: 10.1001/archsurg.136.3.272.
PubMed 11231844Fortelny RH. Abdominal Wall Closure in Elective Midline Laparotomy: The Current Recommendations. Front Surg. 2018 May 23;5:34. doi: 10.3389/fsurg.2018.00034. eCollection 2018.
PubMed 29876355Muysoms FE, Antoniou SA, Bury K, Campanelli G, Conze J, Cuccurullo D, de Beaux AC, Deerenberg EB, East B, Fortelny RH, Gillion JF, Henriksen NA, Israelsson L, Jairam A, Janes A, Jeekel J, Lopez-Cano M, Miserez M, Morales-Conde S, Sanders DL, Simons MP, Smietanski M, Venclauskas L, Berrevoet F; European Hernia Society. European Hernia Society guidelines on the closure of abdominal wall incisions. Hernia. 2015 Feb;19(1):1-24. doi: 10.1007/s10029-014-1342-5. Epub 2015 Jan 25.
PubMed 25618025Tolstrup MB, Watt SK, Gogenur I. Reduced Rate of Dehiscence After Implementation of a Standardized Fascial Closure Technique in Patients Undergoing Emergency Laparotomy. Ann Surg. 2017 Apr;265(4):821-826. doi: 10.1097/SLA.0000000000001762.
PubMed 28267697Denys A, Monbailliu T, Allaeys M, Berrevoet F, van Ramshorst GH. Management of abdominal wound dehiscence: update of the literature and meta-analysis. Hernia. 2021 Apr;25(2):449-462. doi: 10.1007/s10029-020-02294-4. Epub 2020 Sep 8.
PubMed 32897452Pereira Rodriguez JA, Amador-Gil S, Bravo-Salva A, Montcusi-Ventura B, Sancho-Insenser JJ, Pera-Roman M, Lopez-Cano M. Small bites technique for midline laparotomy closure: From theory to practice: Still a long way to go. Surgery. 2021 Jul;170(1):140-145. doi: 10.1016/j.surg.2020.12.007. Epub 2021 Jan 15.
PubMed 33455821
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Wall Dehiscence After Laparotomy Closure in Abdominal Surgery: a Retrospective Observational Study on the Influence of the Suture Used
- ClinicalTrials.gov ID
- NCT06501508
- Acronym / sponsor ID
- SUTURA / PIC089-23_FJD
- Conditions
- Surgical Wound Dehiscence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,900 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Collaborators
- Ethicon, Inc.
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 22 Nov 2024 (estimated)
- Study completion
- 22 Nov 2024 (estimated)
- First posted
- 15 Jul 2024 (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.
In this retrospective longitudinal observational study we compare the incidence of fascial dehiscence and incisional hernia in patients operated via abdominal wall incision, comparing the barbed suture Stratafix Symmetric to other types of suture during closure of the abdominal wall. In addition, we plan to analize the impact of other risk factors, patient related and patient unrelated, on the incidence of fascial dehiscence.
Detailed description
In this retrospective longitudinal observational study we primarily aim to compare the influence of the applied suture type (Stratafix Symmetric versus other suture types) for primary fascial closure in abdominal surgery on the incidence of fascial dehiscence.
Secondary outcomes such as will also be analized. Primary outcomeis the incidence of abdominal wall dehiscence. Secondary outcomes are the impact of the occurrence of abdominal wall dehiscence on mortality and hospital stay, the influence of other risk factors on the occurrence of abdominal wall dehiscence, the influence of the suture type and other risk factors on the incidence of incisional hernia after 12 months of follow-up and a speciality subgroup analysis.
The diagnoses of each patient and the procedures performed are coded according to ICD 9 or ICD 10. For primary cause diagnoses and secondary diagnoses, external causes and procedures, ICD9/ICD10 codes are also used. Following the AHQR definition, cases of laparotomy dehiscence will be defined as those whose ICD 9/ICD 10 codes conform to "New closure of postoperative abdominal wall disruption", as well as those identified secondarily after crossing the databases as reoperated for this reason with another coding.
Statistical analysis will be performed using statistical techniques appropriate to the variables under study. A descriptive analysis of the population will be performed, frequency results will be expressed in absolute terms, such as percentages and confidence intervals. The percentage of subjects with dehiscence will be calculated by the group. A two-sided 95% confidence interval (CI) for the difference in percentages (Stratafix - Control) will be estimated using the Wald method. If the upper limit of the confidence interval for the difference in percentages (Stratafix-Control) is below 0, then it will be concluded that the true dehiscence rate for Stratafix is lower than that for the control. In addition, two-sided 95% CIs within each group will be estimated for the dehiscence rate using the Clopper-Pearson method.
Continuous variables will be expressed as mean (SD) and median (range) according to the normality test (Kolmogorov Smirnov test). For the study of the relationship between the different variables, Chi-square or Analysis of Variance will be used if they are parametric. And if they do not follow a normal distribution, nonparametric tests will be used (Mann-Whitney U or Kruskal Wallis, as appropriate). Biochemical recurrence-free survival (BCR-free survival) will be estimated using Kaplan-Meier curves. SPSS. 21 (SPSS Inc. Chicago, IL, USA) will be used.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stratafix | – | Device: Stratafix SymmetricAll patients in which Stratafix symmetric was used for the primary closure of the abdominal wall incision |
| Control | – | –All patients in which other, conventional suture types were used for primary closure of the abdominal wall incision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults over 18 years of age operated via laparotomy or laparoscopy with extraction site incision in the 4 participating Hospitals between 01/01/2018 and 21/11/23
Key inclusion criteria (1 listed)
- Age over 18 years, abdominal incision or laparoscopy with extraction site incision
Key exclusion criteria (1 listed)
- Pregnancy, use of mesh for fascial closure in primary surgery, history of ventral abdominal hernia surgery
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 |
|---|---|---|
| Stratafix SymmetricUse of Stratafix Symmetric for primary fascial closure | Device | Stratafix |
Primary outcome
Abdominal Wall Dehiscence
Time frame: 30 days
Disruption of all layers of the abdominal wall with exposure of abdominal viscera within 30 days after primary surgery
8 secondary outcomes
Incisional hernia
Time frame: 1 year
PROMs - Postoperative Pain
Time frame: 1 year
PROMs - Mental and emotional health
Time frame: 1 year
PROMs - Work an social life performance
Time frame: 1 year
PROMs - Fatigue
Time frame: 1 year
PROMs - Funcionality
Time frame: 1 year
PROMs - Sexuality
Time frame: 1 year
PROMs - Body image
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Background: PubMed 34537149Zolin SJ, Rosen MJ. Failure of Abdominal Wall Closure: Prevention and Management. Surg Clin North Am. 2021 Oct;101(5):875-888. doi: 10.1016/j.suc.2021.07.001.
- Background: PubMed 16420934Rodriguez-Hermosa JI, Codina-Cazador A, Ruiz B, Roig J, Girones J, Pujadas M, Pont J, Aldeguer X, Acero D. [Risk factors for acute abdominal wall dehiscence after laparotomy in adults]. Cir Esp. 2005 May;77(5):280-6. doi: 10.1016/s0009-739x(05)70854-x. Spanish.
- Background: PubMed 25956459Gili-Ortiz E, Gonzalez-Guerrero R, Bejar-Prado L, Ramirez-Ramirez G, Lopez-Mendez J. [Postoperative dehiscence of the abdominal wound and its impact on excess mortality, hospital stay and costs]. Cir Esp. 2015 Aug-Sep;93(7):444-9. doi: 10.1016/j.ciresp.2015.02.005. Epub 2015 May 6. Spanish.
- Background: PubMed 33394254Jensen KK, Oma E, van Ramshorst GH, Nordholm-Carstensen A, Krarup PM. Abdominal wound dehiscence is dangerous: a nationwide study of 14,169 patients undergoing elective open resection for colonic cancer. Hernia. 2022 Feb;26(1):75-86. doi: 10.1007/s10029-020-02350-z. Epub 2021 Jan 4.
- Background: PubMed 21328764Farquhar M. AHRQ Quality Indicators. In: Hughes RG, editor. Patient Safety and Quality: An Evidence-Based Handbook for Nurses. Rockville (MD): Agency for Healthcare Research and Quality (US); 2008 Apr. Chapter 45. Available from http://www.ncbi.nlm.nih.gov/books/NBK2664/
- Background: PubMed 30286645Zucker BE, Simillis C, Tekkis P, Kontovounisios C. Suture choice to reduce occurrence of surgical site infection, hernia, wound dehiscence and sinus/fistula: a network meta-analysis. Ann R Coll Surg Engl. 2019 Mar;101(3):150-161. doi: 10.1308/rcsann.2018.0170. Epub 2018 Oct 5.
- Background: PubMed 137024Jenkins TP. The burst abdominal wound: a mechanical approach. Br J Surg. 1976 Nov;63(11):873-6. doi: 10.1002/bjs.1800631110.
- Background: PubMed 29322212Henriksen NA, Deerenberg EB, Venclauskas L, Fortelny RH, Miserez M, Muysoms FE. Meta-analysis on Materials and Techniques for Laparotomy Closure: The MATCH Review. World J Surg. 2018 Jun;42(6):1666-1678. doi: 10.1007/s00268-017-4393-9.
- Background: PubMed 29099149Patel SV, Paskar DD, Nelson RL, Vedula SS, Steele SR. Closure methods for laparotomy incisions for preventing incisional hernias and other wound complications. Cochrane Database Syst Rev. 2017 Nov 3;11(11):CD005661. doi: 10.1002/14651858.CD005661.pub2.
- Background: PubMed 11231844Cengiz Y, Blomquist P, Israelsson LA. Small tissue bites and wound strength: an experimental study. Arch Surg. 2001 Mar;136(3):272-5. doi: 10.1001/archsurg.136.3.272.
- Background: PubMed 29876355Fortelny RH. Abdominal Wall Closure in Elective Midline Laparotomy: The Current Recommendations. Front Surg. 2018 May 23;5:34. doi: 10.3389/fsurg.2018.00034. eCollection 2018.
- Background: PubMed 25618025Muysoms FE, Antoniou SA, Bury K, Campanelli G, Conze J, Cuccurullo D, de Beaux AC, Deerenberg EB, East B, Fortelny RH, Gillion JF, Henriksen NA, Israelsson L, Jairam A, Janes A, Jeekel J, Lopez-Cano M, Miserez M, Morales-Conde S, Sanders DL, Simons MP, Smietanski M, Venclauskas L, Berrevoet F; European Hernia Society. European Hernia Society guidelines on the closure of abdominal wall incisions. Hernia. 2015 Feb;19(1):1-24. doi: 10.1007/s10029-014-1342-5. Epub 2015 Jan 25.
- Individual participant dataSharing planned: No
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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.
Marius Kaser, Dr. contact
Hector Gauadalajara Labajo, PHD principal investigator
Quironsalud
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Wound Dehiscence, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hector Gauadalajara Labajo, PHD (0034649429243, h.guadalajara@quironsalud.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal Wall Dehiscence (time frame: 30 days). 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 NCT06501508, which also lists 15 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 15 Jul 2024.