Orthopaedics Wound DressingsNCT06540040
Comparative Efficacy of Advanced and Traditional Wound Dressings in Post-Operative Orthopedic Care
A study testing Aquacel Ag, OPSITE and MEPILEX POST OP BORDER in people with Orthopaedics Wound Dressings, run by Nidhi Srivastava at 1 site in India.
Trial summary
Title: Comparative Efficacy of Advanced and Traditional Wound Dressings in Post-Operative Orthopedic Care: A Randomized Controlled Trial Objective: The primary objective of this study is to evaluate and compare the efficacy of advanced wound dressings versus traditional gauze-based dressings in post-operative… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Orthopaedics Wound Dressings
- What is being tested?
- Aquacel Ag, OPSITE and MEPILEX POST OP BORDER
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteIndia
- Study dates
- 10 Aug 2022to 10 Dec 2022
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 90 years Undergoing orthopedic surgical procedures, elective or trauma, with a surgical wound size of more than 5 cm Provided informed consent
Who cannot join
- Open fractures Revision surgeries Established infections Ongoing pharmacological anticoagulation prophylaxis Predisposing skin conditions Known allergy or hypersensitivity to any of the constituents of the dressings Any associated systemic injury precluding early mobilization Unwillingness to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study to Assess the Efficacy of Postoperative Dressing in the Prevention of Early Surgical Site Complication and Facilitation of Early Mobilization After Orthopaedic Surgeries on Hip and Knee
Title: Comparative Efficacy of Advanced and Traditional Wound Dressings in Post-Operative Orthopedic Care: A Randomized Controlled Trial
Objective:
The primary objective of this study is to evaluate and compare the efficacy of advanced wound dressings versus traditional gauze-based dressings in post-operative orthopedic care. The study aims to assess various parameters including patient comfort, pain management, ease of application, exudate management, and the incidence of early surgical site complications.
Read the detailed description
Title: Comparative Efficacy of Advanced and Traditional Wound Dressings in Post-Operative Orthopedic Care: A Randomized Controlled Trial
Brief Summary:
This study aims to compare the efficacy of advanced wound dressings with traditional gauze-based dressings in post-operative orthopedic care. The study evaluates patient comfort, pain management, ease of application, exudate management, and the incidence of early surgical site complications.
Study Type: Interventional (Clinical Trial)
Study Design: Randomized Controlled Single-Centre Open-Label Study
Primary Purpose: Treatment
Study Start Date: August 10, 2022
Study Completion Date: December 10, 2022
Primary Completion Date: December 10, 2022
Estimated Enrollment: 320 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Interventions:
Participants undergoing orthopedic surgical procedures were randomized into four groups:
Group A: Aquacel Ag (Hydrofibre wound dressing with ionic silver) Group B: OPSITE (Transparent waterproof cotton pad with high Moisture Vapour Transmission Rate) Group C: MEPILEX POST OP BORDER (4-layer foam dressing with flex technology) Group D: Traditional dressing with gauze pieces, surgical pads, and porous paper adhesive strips
Objectives:
To assess the incidence of early surgical site complications such as blisters, infection, maceration, rashes, redness, swelling, and dehiscence at days 3, 7, and 14.
To determine the pain and discomfort experienced by patients during dressing changes using a visual analog scale.
To evaluate the ability to perform activities of daily living comfortably. To assess nurses' ease of application and removal of the dressings.
Outcome Measures:
Primary Outcome Measures: Incidence of surgical site complications at days 3, 7, and 14.
Secondary Outcome Measures: Pain levels during dressing changes, comfort and mobility in daily activities, ease of application and removal of the dressings, and patient satisfaction.
Data Collection Methods:
Data were collected using a semi-structured questionnaire validated by experts. The questionnaire included a wound assessment checklist, a 10-point Likert scale for patient comfort and mobility, a Visual Analog Scale for pain, and a rating scale for nurses' ease of application and removal.
Statistical Analysis:
Categorical variables were presented as numbers and percentages. Continuous variables were presented as mean ± SD and median values. Data normality was checked using the Kolmogorov-Smirnov test. Quantitative variables were analyzed using ANOVA and Kruskal-Wallis test with post hoc tests as appropriate.
Qualitative variables were analyzed using the Chi-Square test or Fisher's exact test for cells with expected values less than 5.
A p-value of less than 0.05 was considered statistically significant.
Ethics and Registration:
Detailed Description:
This study evaluates the comparative efficacy of different wound dressings used in post-operative orthopedic care. The focus is on advanced dressings such as Aquacel Ag, OPSITE, and MEPILEX POST OP BORDER, compared to traditional gauze-based dressings. The study measures various parameters including patient comfort, pain during dressing changes, ease of application and removal by nurses, and management of wound exudate. Data were collected at three time points: days 3, 7, and 14 post-surgery. The results aim to provide insights into the best practices for post-operative wound management in orthopedic patients.
- Conditions
- Orthopaedics Wound Dressings
- Being tested
- Aquacel Ag, OPSITE, MEPILEX POST OP BORDER, Traditional Dressing
- Keywords
- wound healing, surgical wound infection, Randomised Controlled Tmrial, Patient comfort, Pain management
- Medical subject headings
- Surgical Wound Infection, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquacel AgDevice
Also called Hydrofibre wound dressing with ionic silver
Aquacel Ag is a Hydrofibre wound dressing composed of non-woven sodium carboxymethylcellulose fibers integrated with ionic silver. It is designed to provide a moist wound environment and has antimicrobial properties to help reduce the risk of infection. The dressing will be applied post-operatively and changed according to a standardized protocol.
OPSITEDevice
Also called Transparent waterproof cotton pad
OPSITE is a transparent waterproof dressing with a high Moisture Vapour Transmission Rate. It is intended to provide a protective barrier while allowing moisture vapor to escape, maintaining an optimal wound healing environment. The dressing will be applied post-operatively and changed according to a standardized protocol.
MEPILEX POST OP BORDERDevice
Also called 4-layer foam dressing with flex technology
MEPILEX POST OP BORDER is a 4-layer foam dressing designed with flex technology for superior absorption and conformability. It helps manage exudate and protects the wound site. The dressing will be applied post-operatively and changed according to a standardized protocol.
Traditional DressingDevice
Also called Gauze pieces, surgical pads, and porous paper adhesive strips
Traditional dressing involves the use of gauze pieces, surgical pads, and porous paper adhesive strips. This type of dressing is commonly used in post-operative care to absorb exudate and protect the wound site. The dressing will be applied post-operatively and changed according to a standardized protocol.
| Study group | Role | What they receive |
|---|---|---|
| Aquacel Ag | Experimental | Participants in this group will receive Aquacel Ag, a Hydrofibre wound dressing consisting of non-woven sodium carboxymethylcellulose fibres integrated with ionic silver. This dressing is designed to provide a moist wound environment and has antimicrobial properties to help reduce the risk of infection. The dressing will be applied post-operatively and changed as per the standardized protocol. Receives: Device: Aquacel Ag |
| OPSITE | Experimental | Participants in this group will receive OPSITE, a transparent waterproof cotton pad with a high Moisture Vapour Transmission Rate. This dressing is intended to provide a protective barrier while allowing moisture vapor to escape, helping to maintain an optimal wound healing environment. The dressing will be applied post-operatively and changed according to the standardized protocol. Receives: Device: OPSITE |
| MEPILEX POST OP BORDER | Experimental | Participants in this group will receive MEPILEX POST OP BORDER, a 4-layer foam dressing with flex technology. This advanced dressing is designed to provide superior absorption and conformability, helping to manage exudate and protect the wound site. The dressing will be applied post-operatively and changed as per the standardized protocol. Receives: Device: MEPILEX POST OP BORDER |
| Traditional Dressing | Active comparator | Participants in this group will receive traditional wound dressings consisting of gauze pieces, surgical pads, and porous paper adhesive strips. This type of dressing is commonly used in post-operative care to absorb exudate and protect the wound site. The dressing will be applied post-operatively and changed according to the standardized protocol. Receives: Device: Traditional Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Early Surgical Site Complications
The primary outcome measure will be the incidence of early surgical site complications, including blisters, skin margin infection, maceration, rashes, redness, swelling, and wound dehiscence. These complications will be assessed at three time points: day 3, day 7, and day 14 post-surgery.
Measured: Day 3, Day 7, Day 14 post-surgery
Secondary outcomes (4)
Pain Levels During Dressing Changes
Pain levels experienced by patients during dressing changes will be assessed using a Visual Analog Scale (VAS) from 0 to 10, where 0 corresponds to no pain and 10 corresponds to unbearable pain. This will be measured at day 3, day 7, and day 14 post-surgery.
Measured: Day 3, Day 7, Day 14 post-surgery
Patient Comfort and Mobility
Patient comfort and ability to perform activities of daily living will be assessed using a 0-to-10-point scale, where 0 indicates absolute discomfort and 10 indicates no limitation due to the dressing. This will be measured at day 3, day 7, and day 14 post-surgery.
Measured: Day 3, Day 7, Day 14 post-surgery
Nurses' Ease of Application and Removal of Dressings
Nurses will rate the ease of application and removal of the dressing using a 0-to-10-point scale, considering factors such as time taken, difficulty, and any issues encountered during the process. This will be measured at day 3, day 7, and day 14 post-surgery.
Measured: Day 3, Day 7, Day 14 post-surgery
Patient Satisfaction Levels
Patient satisfaction with the dressing will be assessed using a structured questionnaire. This will be measured at day 14 post-surgery.
Measured: Day 14 post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start10 Aug 2022
- Primary completion10 Dec 2022
- Study completion10 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthopaedics Wound DressingsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- \### Model Description \*\*Parallel Assignment\*\*: This study employs a parallel assignment model, where participants are randomly allocated to one of four intervention groups. Each group receives a distinct type of wound dressing post-operatively. The outcomes are measured and compared across these groups to evaluate the efficacy of each dressing type. The interventions include Aquacel Ag, OPSITE, MEPILEX POST OP BORDER, and traditional gauze-based dressings. This model allows for a direct comparison of the different interventions in a controlled manner.
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nidhi Srivastava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nidhi Srivastava, Base Hospital Delhi Cantt
- Investigators
- Amresh Ghai, MS (Ortho), Study director, Base Hospital Delhi Cantt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540040
- Sponsor's protocol ID
- 88/2022
- Status last verified
- Aug 2024
- First submitted
- 2 Aug 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share individual participant data (IPD) with other researchers.
Publications
Srivastava N, Manisha, Ghai A, Goyal M, Kumar M, Kumar M. Comparative efficacy of advanced and traditional wound dressings in post-operative orthopaedic care for hip and knee surgeries: A randomized controlled trial. J Clin Orthop Trauma. 2025 Feb 12;63:102933. doi: 10.1016/j.jcot.2025.102933. eCollection 2025 Apr.
PubMed 40070522
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study to Assess the Efficacy of Postoperative Dressing in the Prevention of Early Surgical Site Complication and Facilitation of Early Mobilization After Orthopaedic Surgeries on Hip and Knee
- ClinicalTrials.gov ID
- NCT06540040
- Acronym / sponsor ID
- 88/2022
- Conditions
- Orthopaedics Wound Dressings
- Keywords
- wound healing, surgical wound infection, Randomised Controlled Tmrial, Patient comfort, Pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Nidhi SrivastavaUniversity, hospital or other
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 10 Dec 2022 (actual)
- Study completion
- 10 Dec 2022 (actual)
- First posted
- 6 Aug 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.
Title: Comparative Efficacy of Advanced and Traditional Wound Dressings in Post-Operative Orthopedic Care: A Randomized Controlled Trial
Objective:
The primary objective of this study is to evaluate and compare the efficacy of advanced wound dressings versus traditional gauze-based dressings in post-operative orthopedic care. The study aims to assess various parameters including patient comfort, pain management, ease of application, exudate management, and the incidence of early surgical site complications.
Detailed description
Title: Comparative Efficacy of Advanced and Traditional Wound Dressings in Post-Operative Orthopedic Care: A Randomized Controlled Trial
Brief Summary:
This study aims to compare the efficacy of advanced wound dressings with traditional gauze-based dressings in post-operative orthopedic care. The study evaluates patient comfort, pain management, ease of application, exudate management, and the incidence of early surgical site complications.
Study Type: Interventional (Clinical Trial)
Study Design: Randomized Controlled Single-Centre Open-Label Study
Primary Purpose: Treatment
Study Start Date: August 10, 2022
Study Completion Date: December 10, 2022
Primary Completion Date: December 10, 2022
Estimated Enrollment: 320 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Interventions:
Participants undergoing orthopedic surgical procedures were randomized into four groups:
Group A: Aquacel Ag (Hydrofibre wound dressing with ionic silver) Group B: OPSITE (Transparent waterproof cotton pad with high Moisture Vapour Transmission Rate) Group C: MEPILEX POST OP BORDER (4-layer foam dressing with flex technology) Group D: Traditional dressing with gauze pieces, surgical pads, and porous paper adhesive strips
Objectives:
To assess the incidence of early surgical site complications such as blisters, infection, maceration, rashes, redness, swelling, and dehiscence at days 3, 7, and 14.
To determine the pain and discomfort experienced by patients during dressing changes using a visual analog scale.
To evaluate the ability to perform activities of daily living comfortably. To assess nurses' ease of application and removal of the dressings.
Outcome Measures:
Primary Outcome Measures: Incidence of surgical site complications at days 3, 7, and 14.
Secondary Outcome Measures: Pain levels during dressing changes, comfort and mobility in daily activities, ease of application and removal of the dressings, and patient satisfaction.
Data Collection Methods:
Data were collected using a semi-structured questionnaire validated by experts. The questionnaire included a wound assessment checklist, a 10-point Likert scale for patient comfort and mobility, a Visual Analog Scale for pain, and a rating scale for nurses' ease of application and removal.
Statistical Analysis:
Categorical variables were presented as numbers and percentages. Continuous variables were presented as mean ± SD and median values. Data normality was checked using the Kolmogorov-Smirnov test. Quantitative variables were analyzed using ANOVA and Kruskal-Wallis test with post hoc tests as appropriate.
Qualitative variables were analyzed using the Chi-Square test or Fisher's exact test for cells with expected values less than 5.
A p-value of less than 0.05 was considered statistically significant.
Ethics and Registration:
Detailed Description:
This study evaluates the comparative efficacy of different wound dressings used in post-operative orthopedic care. The focus is on advanced dressings such as Aquacel Ag, OPSITE, and MEPILEX POST OP BORDER, compared to traditional gauze-based dressings. The study measures various parameters including patient comfort, pain during dressing changes, ease of application and removal by nurses, and management of wound exudate. Data were collected at three time points: days 3, 7, and 14 post-surgery. The results aim to provide insights into the best practices for post-operative wound management in orthopedic patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- ### Model Description Parallel Assignment: This study employs a parallel assignment model, where participants are randomly allocated to one of four intervention groups. Each group receives a distinct type of wound dressing post-operatively. The outcomes are measured and compared across these groups to evaluate the efficacy of each dressing type. The interventions include Aquacel Ag, OPSITE, MEPILEX POST OP BORDER, and traditional gauze-based dressings. This model allows for a direct comparison of the different interventions in a controlled manner.
| Arm | Type | Receives |
|---|---|---|
| Aquacel Ag | Experimental | Device: Aquacel AgParticipants in this group will receive Aquacel Ag, a Hydrofibre wound dressing consisting of non-woven sodium carboxymethylcellulose fibres integrated with ionic silver. This dressing is designed to provide a moist wound environment and has antimicrobial properties to help reduce the risk of infection. The dressing will be applied post-operatively and changed as per the standardized protocol. |
| OPSITE | Experimental | Device: OPSITEParticipants in this group will receive OPSITE, a transparent waterproof cotton pad with a high Moisture Vapour Transmission Rate. This dressing is intended to provide a protective barrier while allowing moisture vapor to escape, helping to maintain an optimal wound healing environment. The dressing will be applied post-operatively and changed according to the standardized protocol. |
| MEPILEX POST OP BORDER | Experimental | Device: MEPILEX POST OP BORDERParticipants in this group will receive MEPILEX POST OP BORDER, a 4-layer foam dressing with flex technology. This advanced dressing is designed to provide superior absorption and conformability, helping to manage exudate and protect the wound site. The dressing will be applied post-operatively and changed as per the standardized protocol. |
| Traditional Dressing | Active comparator | Device: Traditional DressingParticipants in this group will receive traditional wound dressings consisting of gauze pieces, surgical pads, and porous paper adhesive strips. This type of dressing is commonly used in post-operative care to absorb exudate and protect the wound site. The dressing will be applied post-operatively and changed according to the standardized protocol. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age between 18 and 90 years Undergoing orthopedic surgical procedures, elective or trauma, with a surgical wound size of more than 5 cm Provided informed consent
Key exclusion criteria (1 listed)
- Open fractures Revision surgeries Established infections Ongoing pharmacological anticoagulation prophylaxis Predisposing skin conditions Known allergy or hypersensitivity to any of the constituents of the dressings Any associated systemic injury precluding early mobilization Unwillingness to participate
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 |
|---|---|---|
| Aquacel AgAlso: Hydrofibre wound dressing with ionic silverAquacel Ag is a Hydrofibre wound dressing composed of non-woven sodium carboxymethylcellulose fibers integrated with ionic silver. It is designed to provide a moist wound environment and has antimicrobial properties to help reduce the risk of infection. The dressing will be applied post-operatively and changed according to a standardized protocol. | Device | Aquacel Ag |
| OPSITEAlso: Transparent waterproof cotton padOPSITE is a transparent waterproof dressing with a high Moisture Vapour Transmission Rate. It is intended to provide a protective barrier while allowing moisture vapor to escape, maintaining an optimal wound healing environment. The dressing will be applied post-operatively and changed according to a standardized protocol. | Device | OPSITE |
| MEPILEX POST OP BORDERAlso: 4-layer foam dressing with flex technologyMEPILEX POST OP BORDER is a 4-layer foam dressing designed with flex technology for superior absorption and conformability. It helps manage exudate and protects the wound site. The dressing will be applied post-operatively and changed according to a standardized protocol. | Device | MEPILEX POST OP BORDER |
| Traditional DressingAlso: Gauze pieces, surgical pads, and porous paper adhesive stripsTraditional dressing involves the use of gauze pieces, surgical pads, and porous paper adhesive strips. This type of dressing is commonly used in post-operative care to absorb exudate and protect the wound site. The dressing will be applied post-operatively and changed according to a standardized protocol. | Device | Traditional Dressing |
Primary outcome
Incidence of Early Surgical Site Complications
Time frame: Day 3, Day 7, Day 14 post-surgery
The primary outcome measure will be the incidence of early surgical site complications, including blisters, skin margin infection, maceration, rashes, redness, swelling, and wound dehiscence. These complications will be assessed at three time points: day 3, day 7, and day 14 post-surgery.
4 secondary outcomes
Pain Levels During Dressing Changes
Time frame: Day 3, Day 7, Day 14 post-surgery
Patient Comfort and Mobility
Time frame: Day 3, Day 7, Day 14 post-surgery
Nurses' Ease of Application and Removal of Dressings
Time frame: Day 3, Day 7, Day 14 post-surgery
Patient Satisfaction Levels
Time frame: Day 14 post-surgery
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 6 Aug 2024.
- Derived from this study: PubMed 40070522Srivastava N, Manisha, Ghai A, Goyal M, Kumar M, Kumar M. Comparative efficacy of advanced and traditional wound dressings in post-operative orthopaedic care for hip and knee surgeries: A randomized controlled trial. J Clin Orthop Trauma. 2025 Feb 12;63:102933. doi: 10.1016/j.jcot.2025.102933. eCollection 2025 Apr.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data (IPD) with other researchers.
Related trials for Orthopaedics Wound Dressings
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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.
Amresh Ghai, MS (Ortho) study director
Base Hospital Delhi Cantt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquacel Ag, OPSITE and MEPILEX POST OP BORDER in people with Orthopaedics Wound Dressings, run by Nidhi Srivastava at 1 site in India.
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: finished, as of the sponsor's last update on 6 Aug 2024. 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 India. 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?
Incidence of Early Surgical Site Complications (time frame: Day 3, Day 7, Day 14 post-surgery). 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 NCT06540040, which also lists 1 linked publication.
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 6 Aug 2024.