Total Knee ReplacementNCT04492852
Comparison of Surgical Site Infection After Skin Closure by Prolene or Staples in Bilateral Knee Arthroplasty Patients
A study testing Polypropylene (PROLENE) sutures and Staple Sutures in people with Total Knee Replacement, run by Indus Hospital and Health Network.
Trial summary
Knee arthroplasty also known as the total knee replacement is an orthopedic surgical procedure done to resurface the knee that has been severely damaged by arthritis. The optimal goal of skin closure after the procedure is to promote rapid healing and an acceptable cosmetic result while minimizing the risk of… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- Polypropylene (PROLENE) sutures and Staple Sutures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- Nov 2020to Dec 2021
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients of age 40-70 years
- Undergoing bilateral knee arthroplasty at AKUH Karachi.
- Both the genders would be included.
- Patients having American Society of Anesthesiologists (ASA) level of I, II and III
- Patients having functional class of I, II and III pre-operatively
- Patients opting to undergo Bilateral knee arthroplasty under care of the selected surgeon (A) for the study.
- Patients undergoing bilateral TKR electively
Who cannot join
- Patients unwilling to consent.
- Patients unable to comprehend due to the language barrier
- Patients who have a Glasgow Coma Scale i.e. GCS<15 (cognitive impairment)
- Patients undergoing a knee revision surgery
- Patients having a previous incision/scar in the operative field will be excluded
- Patients having documented allergy to Prolene or stainless steel
Show all 10Show fewer
- Patients having a documented underlying malignancy
- Patients undergoing unilateral TKR or staged bilateral TKR
- Patients undergoing emergency TKR.
- Patients having undergoing surgery due to trauma or fracture
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Surgical Site Infection After Skin Closure by Prolene or Staples in Bilateral Knee Arthroplasty Patients: A Parallel Design Randomized Controlled Trial
Knee arthroplasty also known as the total knee replacement is an orthopedic surgical procedure done to resurface the knee that has been severely damaged by arthritis. The optimal goal of skin closure after the procedure is to promote rapid healing and an acceptable cosmetic result while minimizing the risk of infection. Skin closure after knee arthroplasty is done by using either of the two widely used sutures i.e. polypropylene (Prolene) sutures or the skin staple sutures. The literature is very scarce on knee arthroplasty patients and the results of the studies conducted have been inconclusive of the studies conducted on the patients of knee arthroplasty. Moreover, there are no standard guidelines as to which type of suture should be used. The type of sutures is being selected on the orders and wishes of the surgeon at the time of skin closure. Prolene sutures are made up of a synthetic steroisomer known as polypropylene. It is a monofilament non-absorbable, sterile surgical suture. They are indicated for use in general soft tissue. It Provides permanent tensile strength retention in tissue, even in the presence of infection. These sutures are exceptionally smooth for an easy passage through the tissue. Prolene sutures are widely used in cardiovascular, orthopedics, ophthalmic, and neurological surgical procedures. Another type of sutures that are used to close the surgical wound are the staple sutures. They are used as an alternative to the traditional Prolene sutures. They are non-absorbable and usually used on surgical wounds that are big, complex or hard to close by using Prolene. These are specialized staples made up of titanium, stainless steel or plastic.
Interventions:
Read more
The study will have 2 intervention arms. The patients will be randomized to receive either Prolene sutures for wound closure or staple sutures for wound closure. After the application of the intervention, routine care would be given to the patients postoperatively.
Hypothesis:
The investigators hypothesize that there is no difference in the incidence of surgical site infection in bilateral TKR patients with wound closure by Prolene vs staple.
Study Design:
This study will be conducted as an open blinded, parallel design, equivalence randomized controlled trial. The patients would be randomized to receive either of the two interventions i.e. Prolene or Staple sutures.
Read the detailed description
Study Enrollment Procedures:
Enrollment will be a continuous process with screening and enrolling eligible patients admitted through the clinic electively for primary TKR. Informed consent will be taken from the patient as per routine protocol before the arthroplasty procedures in the hospital. Research objectives, methodology, risks, and benefits will be explained in detail. Consent for the participation in the study will only be taken by the primary investigator at his clinic or the surgical resident on call preoperatively along with the consent for the surgical procedure.
Pre-Randomization Evaluations Screening:
The screening will involve the routine history taking and physical examination by the doctor and nursing staff in the clinic. Screening won't involve performing procedures that are not part of routine management.
On-study/on-intervention evaluations:
After screening and assessing the eligibility, patients will be randomly allocated by a 1:1 ratio to the two intervention groups i.e. prolene or staple using a computer-generated randomization sequence by the clinical trials unit (CTU), which they will provide to the PI, after patients' admission in the hospital. Patients will be followed from the time they reach the ward after surgery until their hospital discharge, which is usually around 7 days.
Data Collection:
The data collection will be done by the surgical site infection (SSI) nurses from the infection control department of AKUH. These nurses are well-trained to assess the surgical site infections in all the surgery patients admitted to the hospital. Training of data collectors will be done by the PI to ensure the reliability and validity of the study. The data collectors will be strictly instructed to respect the autonomy of participants. Data collection will be done by the data collectors under the supervision of the PI and CTU. Questionnaires will be checked for consistency and logical data entries. Data entry will be done, and counter checked by the PI at regular intervals.
Data Storage:
Data collected will be coded and kept confidential without the identifiable information of patients. The confidentiality of the study participants will be maintained throughout the study period. Data collected will be kept confidential without identifiable information of patients who are identified by a number assigned. The hard copy forms will be retained in a secured location with the PI after data entry into computer software and will be kept as per hospital protocol. The password-protected drives will be used to store data with only the PI having access to it. The data will be available for AKUH ethical review committee on request and might be published in a journal without disclosing any identifiable information of patients. Filled questionnaires will be stored for 5 years after the study is completed as per the policy of the institute.
Sample Size:
The sample size was calculated via open epi software version 3.01. The level of significance was kept at 5% with a power of 80%. The percentage of exposed (staple sutures) with outcome (surgical site infection) was 66%. The percentage of non-exposed (Prolene sutures) with outcome (surgical site infection) was 33%. The estimated risk ratio taken from a study was 2. After adding the non-response rate of 10% the final sample size came out to be 82 patients with 41 patients in each arm.
Plan of Analysis:
Statistical analysis will be done by using STATA software version 15. The normality assumption for the quantitative variables would be assessed using the shapiro wilk test. Mean ± SD will be computed for all the normally distributed quantitative variables. The median and interquartile range would be reported for the non-normally distributed quantitative variables. The categorical variables would be expressed in frequencies and percentages. The Cox Proportional Hazard regression will be used for the univariate and multivariable analysis. Univariate analysis will be conducted, and crude risk ratios and their 95% confidence intervals will be obtained. All significant independent variables at the univariate stage will be regressed in a multivariable cox proportional hazard regression using the stepwise method in the multivariable model and the adjusted risk ratios will be obtained.
- Conditions
- Total Knee Replacement
- Being tested
- Polypropylene (PROLENE) sutures, Staple Sutures
- Keywords
- Knee Replacement, Prolene, Staples, Surgical Site Infection, Skin Closure
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polypropylene (PROLENE) suturesProcedure or surgery
After total knee replacement, the skin closure of the patients in this group will be done using polypropylene (PROLENE) sutures.
Staple SuturesProcedure or surgery
After total knee replacement, the skin closure of the patients in this group will be done using staple sutures.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Arm 1 | Experimental | After total knee replacement, the skin closure of the patients in this group will be done using polypropylene (PROLENE) sutures. Receives: Procedure: Polypropylene (PROLENE) sutures |
| Interventional Arm 2 | Active comparator | After total knee replacement, the skin closure of the patients in this group will be done using staple sutures. Receives: Procedure: Staple Sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection
Primary outcome of the study is the incidence of surgical site infection (superficial or deep) within 6 weeks for superficial infections and 1 year for deep infections.
Measured: 6 weeks for superficial infections and 1 year for deep infections
Secondary outcomes (2)
Post Operative complications
The secondary outcomes of the study include the incidence of post-operative complication that includes; seroma, hematoma, pain, or bleeding
Measured: Within 2 weeks of surgery
Pain Score
assess and compare the pain scores at the time of suture removal using the Visual Analogue Scale (VAS) pain scale. score of '0' represents no pain whereas a score of '10' represents severe/unbearable pain.
Measured: post-operative follow up at 14th post-op day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study startNov 2020 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionDec 2021 (estimated)
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 Total Knee ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indus Hospital and Health Network
- Sponsor type
- University, hospital or other
- Collaborators
- Aga Khan University
- Responsible party
- Principal investigator, Ahsun Jiwani, Indus Hospital and Health Network
- Investigators
- Ahsun Jiwani, MSc. Epibio, Principal investigator, The Indus Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492852
- Sponsor's protocol ID
- 456-784-7
- Status last verified
- Jul 2020
- First submitted
- 27 Jul 2020
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu S, Wang Y, Kotian RN, Li H, Mi Y, Zhang Y, He X. Comparison of Nonabsorbable and Absorbable Suture in Total Knee Arthroplasty. Med Sci Monit. 2018 Oct 23;24:7563-7569. doi: 10.12659/MSM.910785.
PubMed 30350827Barrow J, Divecha H, Board T. Skin closure in arthroplasty surgery: Current practice. Int Wound J. 2018 Dec;15(6):966-970. doi: 10.1111/iwj.12956. Epub 2018 Jul 6.
PubMed 29978557Smith TO, Sexton D, Mann C, Donell S. Sutures versus staples for skin closure in orthopaedic surgery: meta-analysis. BMJ. 2010 Mar 16;340:c1199. doi: 10.1136/bmj.c1199.
PubMed 20234041Gatt D, Quick CR, Owen-Smith MS. Staples for wound closure: a controlled trial. Ann R Coll Surg Engl. 1985 Sep;67(5):318-20.
PubMed 3901864Clayer M, Southwood RT. Comparative study of skin closure in hip surgery. Aust N Z J Surg. 1991 May;61(5):363-5. doi: 10.1111/j.1445-2197.1991.tb00235.x.
PubMed 2025190Khan RJ, Fick D, Yao F, Tang K, Hurworth M, Nivbrant B, Wood D. A comparison of three methods of wound closure following arthroplasty: a prospective, randomised, controlled trial. J Bone Joint Surg Br. 2006 Feb;88(2):238-42. doi: 10.1302/0301-620X.88B2.16923.
PubMed 16434531Hasan O, Jiwani A, Mazhar L, Begum D, Lakdawala R, Noordin S. Comparison of Surgical Site Infection After Skin Closure by Prolene or Staples in Bilateral Simultaneous Knee Arthroplasty Patients: A Parallel Design Randomized Controlled Trial Protocol. Int J Surg Protoc. 2021 Aug 6;25(1):154-159. doi: 10.29337/ijsp.153. eCollection 2021.
PubMed 34430763
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Surgical Site Infection After Skin Closure by Prolene or Staples in Bilateral Knee Arthroplasty Patients: A Parallel Design Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04492852
- Acronym / sponsor ID
- 456-784-7
- Conditions
- Total Knee Replacement
- Keywords
- Knee Replacement, Prolene, Staples, Surgical Site Infection, Skin Closure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Indus Hospital and Health NetworkUniversity, hospital or other
- Collaborators
- Aga Khan University
- Study start
- Nov 2020 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 30 Jul 2020 (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.
Knee arthroplasty also known as the total knee replacement is an orthopedic surgical procedure done to resurface the knee that has been severely damaged by arthritis. The optimal goal of skin closure after the procedure is to promote rapid healing and an acceptable cosmetic result while minimizing the risk of infection. Skin closure after knee arthroplasty is done by using either of the two widely used sutures i.e. polypropylene (Prolene) sutures or the skin staple sutures. The literature is very scarce on knee arthroplasty patients and the results of the studies conducted have been inconclusive of the studies conducted on the patients of knee arthroplasty. Moreover, there are no standard guidelines as to which type of suture should be used. The type of sutures is being selected on the orders and wishes of the surgeon at the time of skin closure. Prolene sutures are made up of a synthetic steroisomer known as polypropylene. It is a monofilament non-absorbable, sterile surgical suture. They are indicated for use in general soft tissue. It Provides permanent tensile strength retention in tissue, even in the presence of infection. These sutures are exceptionally smooth for an easy passage through the tissue. Prolene sutures are widely used in cardiovascular, orthopedics, ophthalmic, and neurological surgical procedures. Another type of sutures that are used to close the surgical wound are the staple sutures. They are used as an alternative to the traditional Prolene sutures. They are non-absorbable and usually used on surgical wounds that are big, complex or hard to close by using Prolene. These are specialized staples made up of titanium, stainless steel or plastic.
Interventions:
The study will have 2 intervention arms. The patients will be randomized to receive either Prolene sutures for wound closure or staple sutures for wound closure. After the application of the intervention, routine care would be given to the patients postoperatively.
Hypothesis:
The investigators hypothesize that there is no difference in the incidence of surgical site infection in bilateral TKR patients with wound closure by Prolene vs staple.
Study Design:
This study will be conducted as an open blinded, parallel design, equivalence randomized controlled trial. The patients would be randomized to receive either of the two interventions i.e. Prolene or Staple sutures.
Detailed description
Study Enrollment Procedures:
Enrollment will be a continuous process with screening and enrolling eligible patients admitted through the clinic electively for primary TKR. Informed consent will be taken from the patient as per routine protocol before the arthroplasty procedures in the hospital. Research objectives, methodology, risks, and benefits will be explained in detail. Consent for the participation in the study will only be taken by the primary investigator at his clinic or the surgical resident on call preoperatively along with the consent for the surgical procedure.
Pre-Randomization Evaluations Screening:
The screening will involve the routine history taking and physical examination by the doctor and nursing staff in the clinic. Screening won't involve performing procedures that are not part of routine management.
On-study/on-intervention evaluations:
After screening and assessing the eligibility, patients will be randomly allocated by a 1:1 ratio to the two intervention groups i.e. prolene or staple using a computer-generated randomization sequence by the clinical trials unit (CTU), which they will provide to the PI, after patients' admission in the hospital. Patients will be followed from the time they reach the ward after surgery until their hospital discharge, which is usually around 7 days.
Data Collection:
The data collection will be done by the surgical site infection (SSI) nurses from the infection control department of AKUH. These nurses are well-trained to assess the surgical site infections in all the surgery patients admitted to the hospital. Training of data collectors will be done by the PI to ensure the reliability and validity of the study. The data collectors will be strictly instructed to respect the autonomy of participants. Data collection will be done by the data collectors under the supervision of the PI and CTU. Questionnaires will be checked for consistency and logical data entries. Data entry will be done, and counter checked by the PI at regular intervals.
Data Storage:
Data collected will be coded and kept confidential without the identifiable information of patients. The confidentiality of the study participants will be maintained throughout the study period. Data collected will be kept confidential without identifiable information of patients who are identified by a number assigned. The hard copy forms will be retained in a secured location with the PI after data entry into computer software and will be kept as per hospital protocol. The password-protected drives will be used to store data with only the PI having access to it. The data will be available for AKUH ethical review committee on request and might be published in a journal without disclosing any identifiable information of patients. Filled questionnaires will be stored for 5 years after the study is completed as per the policy of the institute.
Sample Size:
The sample size was calculated via open epi software version 3.01. The level of significance was kept at 5% with a power of 80%. The percentage of exposed (staple sutures) with outcome (surgical site infection) was 66%. The percentage of non-exposed (Prolene sutures) with outcome (surgical site infection) was 33%. The estimated risk ratio taken from a study was 2. After adding the non-response rate of 10% the final sample size came out to be 82 patients with 41 patients in each arm.
Plan of Analysis:
Statistical analysis will be done by using STATA software version 15. The normality assumption for the quantitative variables would be assessed using the shapiro wilk test. Mean ± SD will be computed for all the normally distributed quantitative variables. The median and interquartile range would be reported for the non-normally distributed quantitative variables. The categorical variables would be expressed in frequencies and percentages. The Cox Proportional Hazard regression will be used for the univariate and multivariable analysis. Univariate analysis will be conducted, and crude risk ratios and their 95% confidence intervals will be obtained. All significant independent variables at the univariate stage will be regressed in a multivariable cox proportional hazard regression using the stepwise method in the multivariable model and the adjusted risk ratios will be obtained.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm 1 | Experimental | Procedure: Polypropylene (PROLENE) suturesAfter total knee replacement, the skin closure of the patients in this group will be done using polypropylene (PROLENE) sutures. |
| Interventional Arm 2 | Active comparator | Procedure: Staple SuturesAfter total knee replacement, the skin closure of the patients in this group will be done using staple sutures. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patients of age 40-70 years
- Undergoing bilateral knee arthroplasty at AKUH Karachi.
- Both the genders would be included.
- Patients having American Society of Anesthesiologists (ASA) level of I, II and III
- Patients having functional class of I, II and III pre-operatively
Key exclusion criteria (10 listed)
- Patients unwilling to consent.
- Patients unable to comprehend due to the language barrier
- Patients who have a Glasgow Coma Scale i.e. GCS<15 (cognitive impairment)
- Patients undergoing a knee revision surgery
- Patients having a previous incision/scar in the operative field will be excluded
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 |
|---|---|---|
| Polypropylene (PROLENE) suturesAfter total knee replacement, the skin closure of the patients in this group will be done using polypropylene (PROLENE) sutures. | Procedure or surgery | Interventional Arm 1 |
| Staple SuturesAfter total knee replacement, the skin closure of the patients in this group will be done using staple sutures. | Procedure or surgery | Interventional Arm 2 |
Primary outcome
Surgical Site Infection
Time frame: 6 weeks for superficial infections and 1 year for deep infections
Primary outcome of the study is the incidence of surgical site infection (superficial or deep) within 6 weeks for superficial infections and 1 year for deep infections.
2 secondary outcomes
Post Operative complications
Time frame: Within 2 weeks of surgery
Pain Score
Time frame: post-operative follow up at 14th post-op day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
- Background: PubMed 30350827Liu S, Wang Y, Kotian RN, Li H, Mi Y, Zhang Y, He X. Comparison of Nonabsorbable and Absorbable Suture in Total Knee Arthroplasty. Med Sci Monit. 2018 Oct 23;24:7563-7569. doi: 10.12659/MSM.910785.
- Background: PubMed 29978557Barrow J, Divecha H, Board T. Skin closure in arthroplasty surgery: Current practice. Int Wound J. 2018 Dec;15(6):966-970. doi: 10.1111/iwj.12956. Epub 2018 Jul 6.
- Results publication: PubMed 20234041Smith TO, Sexton D, Mann C, Donell S. Sutures versus staples for skin closure in orthopaedic surgery: meta-analysis. BMJ. 2010 Mar 16;340:c1199. doi: 10.1136/bmj.c1199.
- Results publication: PubMed 3901864Gatt D, Quick CR, Owen-Smith MS. Staples for wound closure: a controlled trial. Ann R Coll Surg Engl. 1985 Sep;67(5):318-20.
- Results publication: PubMed 2025190Clayer M, Southwood RT. Comparative study of skin closure in hip surgery. Aust N Z J Surg. 1991 May;61(5):363-5. doi: 10.1111/j.1445-2197.1991.tb00235.x.
- Results publication: PubMed 16434531Khan RJ, Fick D, Yao F, Tang K, Hurworth M, Nivbrant B, Wood D. A comparison of three methods of wound closure following arthroplasty: a prospective, randomised, controlled trial. J Bone Joint Surg Br. 2006 Feb;88(2):238-42. doi: 10.1302/0301-620X.88B2.16923.
- Derived from this study: PubMed 34430763Hasan O, Jiwani A, Mazhar L, Begum D, Lakdawala R, Noordin S. Comparison of Surgical Site Infection After Skin Closure by Prolene or Staples in Bilateral Simultaneous Knee Arthroplasty Patients: A Parallel Design Randomized Controlled Trial Protocol. Int J Surg Protoc. 2021 Aug 6;25(1):154-159. doi: 10.29337/ijsp.153. eCollection 2021.
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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.
Ahsun Jiwani, MSc. Epibio principal investigator
The Indus Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Polypropylene (PROLENE) sutures and Staple Sutures in people with Total Knee Replacement, run by Indus Hospital and Health Network.
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 10 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 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Dr Shahryar Noordin (+922134864350 ext. 4350, shahryar.noordin@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infection (time frame: 6 weeks for superficial infections and 1 year for deep infections). 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 NCT04492852, 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 3 Aug 2020.