Chronic PainPolySutureNCT07280975
Comparing Polyglactin vs Polypropylene Sutures for Rectus Sheath Closure
A study testing Polyglactin 910 (Vicryl) Suture and Polypropylene (Prolene) Suture in people with Chronic Pain and Wound Dehiscence, run by Lady Reading Hospital, Pakistan at 1 site in Pakistan.
Trial summary
This randomized controlled trial aims to compare the outcomes of Polyglactin (Vicryl) versus Polypropylene (Prolene) sutures for rectus sheath closure in patients undergoing midline laparotomy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Pain, Wound Dehiscence, Surgical Site Infection (SSI)
- What is being tested?
- Polyglactin 910 (Vicryl) Suture and Polypropylene (Prolene) Suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2026to 30 Jul 2027
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-70 years.
- Type of Surgery: Patients undergoing elective or emergency midline laparotomy.
- Wound Classification: Clean or clean-contaminated wounds (CDC Class I or II).
- Ability to Provide Informed Consent: Participants must be able to understand and sign the informed consent form.
- Availability for Follow-Up: Participants must be available for 6 months follow-up.
Who cannot join
- Contaminated or Dirty Wounds: Patients with CDC Class III or IV wounds.
- Immunocompromised Conditions: Patients on steroids, chemotherapy, or those with HIV.
- Previous Midline Laparotomy with Incisional Hernia: Patients who have a history of incisional hernia after midline laparotomy.
- Severe Malnutrition: Patients with BMI < 16 kg/m² or albumin < 2.5 g/dL.
- Emergency Laparotomy with Hemodynamic Instability: Patients who are unstable or in a critical condition.
- Pregnancy: Pregnant women.
- Need for Temporary Abdominal Closure or Planned Reoperation: Patients requiring staged reoperation or temporary closure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Lady Reading Hospital, Department of General Surgery
Peshawar, Khyber Pakhtunkhwa, 25000
About this study
Official title: Comparative Outcomes of Polyglactin Versus Polypropylene Sutures for Rectus Sheath Closure: A Randomized Controlled Trial
This randomized controlled trial aims to compare the outcomes of Polyglactin (Vicryl) versus Polypropylene (Prolene) sutures for rectus sheath closure in patients undergoing midline laparotomy. The study will evaluate the rates of incisional hernia, surgical site infection (SSI), wound dehiscence, chronic pain, and suture sinus formation. Participants aged 18-70 years, undergoing either elective or emergency laparotomy, will be randomly assigned to receive either Polyglactin or Polypropylene sutures. The primary outcome measure is the incidence of incisional hernia at 6 months, with secondary outcomes including SSI, wound complications, and chronic pain. The study is particularly important in the context of Pakistan, where such comparative data is limited, and aims to provide evidence-based recommendations for optimal suture material selection in general surgery.
Read the detailed description
Study Design This randomized controlled trial is designed to compare the outcomes of two suture materials-Polyglactin 910 (Vicryl) and Polypropylene (Prolene)-for rectus sheath closure after midline laparotomy. The study will be conducted at the Department of General Surgery, Lady Reading Hospital, Peshawar, over 12 months. Participants will be randomly assigned to two groups: Group A (Polyglactin) and Group B (Polypropylene). The primary outcome is the rate of incisional hernia at 6 months postoperatively. Secondary outcomes include surgical site infection (SSI), wound dehiscence, chronic pain, and suture sinus formation.
■ Participants The study will include patients aged 18 to 70 years undergoing elective or emergency midline laparotomy with clean or clean-contaminated wounds (CDC Class I or II).
Inclusion Criteria:
Aged 18-70 years
Elective or emergency laparotomy
Clean or clean-contaminated wounds
Ability to provide informed consent
Availability for 6-month follow-up
Exclusion Criteria:
Contaminated or dirty wounds (CDC Class III or IV)
Immunocompromised patients (e.g., on steroids, chemotherapy, HIV)
Prior midline laparotomy with incisional hernia
Severe malnutrition (BMI <16 kg/m² or albumin <2.5 g/dL)
Pregnancy
Requirement for temporary abdominal closure or planned reoperation
■ Interventions
Polyglactin (Vicryl): A synthetic absorbable braided suture composed of glycolide and lactide copolymers. It is absorbed by hydrolysis over 56-70 days, providing temporary wound support during healing.
Polypropylene (Prolene): A synthetic non-absorbable monofilament suture known for its permanent tensile strength and excellent biocompatibility, offering long-term mechanical support and minimal tissue reaction.
Outcome Measures
Primary Outcome:
Incidence of incisional hernia at 6 months, confirmed by clinical examination and ultrasound if necessary.
Secondary Outcomes:
Surgical Site Infection (SSI): Defined as an infection occurring within 30 days post-surgery, classified as superficial, deep, or organ/space.
Wound Dehiscence: Partial or complete disruption of the abdominal wall closure within 30 days post-surgery.
Chronic Pain: Persistent pain at the surgical site lasting more than 3 months, assessed using the Visual Analog Scale (VAS).
Suture Sinus Formation: Chronic draining tract related to the suture material.
Statistical Analysis Data will be analyzed using SPSS version 26. Chi-square tests will compare proportions of complications between the two groups, and relative risk will be calculated with 95% confidence intervals. Stratified analysis will assess the impact of potential modifiers such as age, gender, and comorbidities (e.g., diabetes, hypertension).
Potential Impact The findings from this study aim to improve surgical outcomes in Pakistan and similar settings. By identifying the more effective suture material for rectus sheath closure, this research will help guide clinical practices, reducing common complications like incisional hernia and infection. It may also contribute to better surgical standards in regions lacking high-quality comparative data.
- Conditions
- Chronic Pain, Wound Dehiscence, Surgical Site Infection (SSI), Incisional Hernia, Rectus Sheath Closure, Abdominal Surgery
- Being tested
- Polyglactin 910 (Vicryl) Suture, Polypropylene (Prolene) Suture
- Keywords
- Polyglactin Sutures, Polypropylene Sutures, Non-Absorbable Sutures, Postoperative Complications, Midline Laparotomy
- Medical subject headings
- Chronic Pain, Surgical Wound Infection, Incisional Hernia, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyglactin 910 (Vicryl) SutureProcedure or surgery
Polyglactin 910 (Vicryl) is an absorbable synthetic multifilament suture material used for rectus sheath closure following laparotomy. This suture material undergoes hydrolytic degradation over a period of 56-70 days and retains approximately 75% of its tensile strength at 2 weeks and 50% at 3 weeks, which aligns with the typical biological timeline for fascial healing. It is used to approximate the anterior rectus sheath with a continuous suturing technique.
Polypropylene (Prolene) SutureProcedure or surgery
Polypropylene (Prolene) is a non-absorbable monofilament suture material used for rectus sheath closure following laparotomy. It provides long-term mechanical support for abdominal wall closure and does not degrade over time. The suture material maintains its tensile strength indefinitely and is known for its high biocompatibility, minimal tissue reaction, and resistance to infection due to its monofilament structure. It is applied using a continuous suturing technique.
| Study group | Role | What they receive |
|---|---|---|
| Polyglactin 910 (Vicryl) Suture for Rectus Sheath Closure | Experimental | In this arm, participants will undergo rectus sheath closure using polyglactin 910 (Vicryl), a synthetic absorbable braided suture. This material is designed to provide temporary wound support during the healing process, with predictable hydrolytic degradation over 56-70 days. The intervention involves continuous suturing of the rectus sheath, with the suture size being 1 (USP). The primary aim is to evaluate postoperative outcomes such as incisional hernia, surgical site infections, wound dehiscence, and chronic pain, using polyglactin sutures for abdominal wall closure.Polyglactin 910 (Vicryl) Suture for Rectus Sheath Closure Receives: Procedure: Polyglactin 910 (Vicryl) Suture |
| Polypropylene (Prolene) Suture for Rectus Sheath Closure | Active comparator | In this arm, participants will undergo rectus sheath closure using polypropylene (Prolene), a non-absorbable monofilament suture. Polypropylene is known for its high tensile strength and biocompatibility, providing long-term mechanical support without being absorbed by the body. The intervention will involve continuous suturing of the rectus sheath, using a size 1 (USP) suture. The main focus will be to assess the incidence of complications such as incisional hernia, surgical site infection, wound dehiscence, and chronic pain following closure with polypropylene sutures. Receives: Procedure: Polypropylene (Prolene) Suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incisional Hernia rate
The primary outcome will assess the rate of incisional hernia at 6 months post-surgery in patients who undergo rectus sheath closure with either Polyglactin 910 (Vicryl) or Polypropylene (Prolene) sutures.
Measured: 6 months postoperatively
Secondary outcomes (4)
Surgical Site Infection (SSI) Rate
This outcome will measure the occurrence of any surgical site infection (SSI) within 30 days postoperatively.
Measured: 30 days post-surgery
Suture Sinus Formation
The occurrence of chronic draining tracts at the incision site, which are associated with the suture material.
Measured: 6 months post-surgery
Chronic Pain (Visual Analog Scale, VAS ≥4)
The presence of chronic pain at the surgical site lasting more than 3 months postoperatively, assessed using the Visual Analog Scale (VAS), where the VAS is a 10-point scale ranging from 0 (no pain) to 10 (worst possible pain). A score of 4 or higher indicates the presence of clinically significant chronic pain.
Measured: 3 months post-surgery
Wound Dehiscence
The occurrence of wound dehiscence, defined as partial or complete disruption of the rectus sheath, within 30 days post-surgery.
Measured: 30 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start1 Apr 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel-group design, where participants are assigned to one of two treatment arms (polyglactin or polypropylene). Both arms will undergo the same procedure but with different suture materials for rectus sheath closure.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lady Reading Hospital, Pakistan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Waseem Ullah, Lady Reading Hospital, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280975
- Sponsor's protocol ID
- 563/LRH/MTI
- Acronym
- PolySuture
- Status last verified
- Dec 2025
- First submitted
- 28 Nov 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data (IPD) that will be shared includes de-identified demographic information, surgical details, treatment outcomes, and relevant follow-up data (e.g., wound healing, incidence of complications, pain scores, and hernia occurrence). This will provide valuable insight into the comparative efficacy of polyglactin versus polypropylene sutures for rectus sheath closure. The data will be available to qualified researchers after the primary results have been published and the study is concluded.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Outcomes of Polyglactin Versus Polypropylene Sutures for Rectus Sheath Closure: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07280975
- Acronym / sponsor ID
- PolySuture / 563/LRH/MTI
- Conditions
- Chronic Pain, Wound Dehiscence, Surgical Site Infection (SSI), Incisional Hernia, Rectus Sheath Closure, Abdominal Surgery
- Keywords
- Polyglactin Sutures, Polypropylene Sutures, Non-Absorbable Sutures, Postoperative Complications, Midline Laparotomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Lady Reading Hospital, PakistanOther government
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 15 Dec 2025 (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.
This randomized controlled trial aims to compare the outcomes of Polyglactin (Vicryl) versus Polypropylene (Prolene) sutures for rectus sheath closure in patients undergoing midline laparotomy. The study will evaluate the rates of incisional hernia, surgical site infection (SSI), wound dehiscence, chronic pain, and suture sinus formation. Participants aged 18-70 years, undergoing either elective or emergency laparotomy, will be randomly assigned to receive either Polyglactin or Polypropylene sutures. The primary outcome measure is the incidence of incisional hernia at 6 months, with secondary outcomes including SSI, wound complications, and chronic pain. The study is particularly important in the context of Pakistan, where such comparative data is limited, and aims to provide evidence-based recommendations for optimal suture material selection in general surgery.
Detailed description
Study Design This randomized controlled trial is designed to compare the outcomes of two suture materials-Polyglactin 910 (Vicryl) and Polypropylene (Prolene)-for rectus sheath closure after midline laparotomy. The study will be conducted at the Department of General Surgery, Lady Reading Hospital, Peshawar, over 12 months. Participants will be randomly assigned to two groups: Group A (Polyglactin) and Group B (Polypropylene). The primary outcome is the rate of incisional hernia at 6 months postoperatively. Secondary outcomes include surgical site infection (SSI), wound dehiscence, chronic pain, and suture sinus formation.
■ Participants The study will include patients aged 18 to 70 years undergoing elective or emergency midline laparotomy with clean or clean-contaminated wounds (CDC Class I or II).
Inclusion Criteria:
Aged 18-70 years
Elective or emergency laparotomy
Clean or clean-contaminated wounds
Ability to provide informed consent
Availability for 6-month follow-up
Exclusion Criteria:
Contaminated or dirty wounds (CDC Class III or IV)
Immunocompromised patients (e.g., on steroids, chemotherapy, HIV)
Prior midline laparotomy with incisional hernia
Severe malnutrition (BMI <16 kg/m² or albumin <2.5 g/dL)
Pregnancy
Requirement for temporary abdominal closure or planned reoperation
■ Interventions
Polyglactin (Vicryl): A synthetic absorbable braided suture composed of glycolide and lactide copolymers. It is absorbed by hydrolysis over 56-70 days, providing temporary wound support during healing.
Polypropylene (Prolene): A synthetic non-absorbable monofilament suture known for its permanent tensile strength and excellent biocompatibility, offering long-term mechanical support and minimal tissue reaction.
Outcome Measures
Primary Outcome:
Incidence of incisional hernia at 6 months, confirmed by clinical examination and ultrasound if necessary.
Secondary Outcomes:
Surgical Site Infection (SSI): Defined as an infection occurring within 30 days post-surgery, classified as superficial, deep, or organ/space.
Wound Dehiscence: Partial or complete disruption of the abdominal wall closure within 30 days post-surgery.
Chronic Pain: Persistent pain at the surgical site lasting more than 3 months, assessed using the Visual Analog Scale (VAS).
Suture Sinus Formation: Chronic draining tract related to the suture material.
Statistical Analysis Data will be analyzed using SPSS version 26. Chi-square tests will compare proportions of complications between the two groups, and relative risk will be calculated with 95% confidence intervals. Stratified analysis will assess the impact of potential modifiers such as age, gender, and comorbidities (e.g., diabetes, hypertension).
Potential Impact The findings from this study aim to improve surgical outcomes in Pakistan and similar settings. By identifying the more effective suture material for rectus sheath closure, this research will help guide clinical practices, reducing common complications like incisional hernia and infection. It may also contribute to better surgical standards in regions lacking high-quality comparative data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a parallel-group design, where participants are assigned to one of two treatment arms (polyglactin or polypropylene). Both arms will undergo the same procedure but with different suture materials for rectus sheath closure.
| Arm | Type | Receives |
|---|---|---|
| Polyglactin 910 (Vicryl) Suture for Rectus Sheath Closure | Experimental | Procedure: Polyglactin 910 (Vicryl) SutureIn this arm, participants will undergo rectus sheath closure using polyglactin 910 (Vicryl), a synthetic absorbable braided suture. This material is designed to provide temporary wound support during the healing process, with predictable hydrolytic degradation over 56-70 days. The intervention involves continuous suturing of the rectus sheath, with the suture size being 1 (USP). The primary aim is to evaluate postoperative outcomes such as incisional hernia, surgical site infections, wound dehiscence, and chronic pain, using polyglactin sutures for abdominal wall closure.Polyglactin 910 (Vicryl) Suture for Rectus Sheath Closure |
| Polypropylene (Prolene) Suture for Rectus Sheath Closure | Active comparator | Procedure: Polypropylene (Prolene) SutureIn this arm, participants will undergo rectus sheath closure using polypropylene (Prolene), a non-absorbable monofilament suture. Polypropylene is known for its high tensile strength and biocompatibility, providing long-term mechanical support without being absorbed by the body. The intervention will involve continuous suturing of the rectus sheath, using a size 1 (USP) suture. The main focus will be to assess the incidence of complications such as incisional hernia, surgical site infection, wound dehiscence, and chronic pain following closure with polypropylene sutures. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18-70 years.
- Type of Surgery: Patients undergoing elective or emergency midline laparotomy.
- Wound Classification: Clean or clean-contaminated wounds (CDC Class I or II).
- Ability to Provide Informed Consent: Participants must be able to understand and sign the informed consent form.
- Availability for Follow-Up: Participants must be available for 6 months follow-up.
Key exclusion criteria (7 listed)
- Contaminated or Dirty Wounds: Patients with CDC Class III or IV wounds.
- Immunocompromised Conditions: Patients on steroids, chemotherapy, or those with HIV.
- Previous Midline Laparotomy with Incisional Hernia: Patients who have a history of incisional hernia after midline laparotomy.
- Severe Malnutrition: Patients with BMI < 16 kg/m² or albumin < 2.5 g/dL.
- Emergency Laparotomy with Hemodynamic Instability: Patients who are unstable or in a critical condition.
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 |
|---|---|---|
| Polyglactin 910 (Vicryl) SuturePolyglactin 910 (Vicryl) is an absorbable synthetic multifilament suture material used for rectus sheath closure following laparotomy. This suture material undergoes hydrolytic degradation over a period of 56-70 days and retains approximately 75% of its tensile strength at 2 weeks and 50% at 3 weeks, which aligns with the typical biological timeline for fascial healing. It is used to approximate the anterior rectus sheath with a continuous suturing technique. | Procedure or surgery | Polyglactin 910 (Vicryl) Suture for Rectus Sheath Closure |
| Polypropylene (Prolene) SuturePolypropylene (Prolene) is a non-absorbable monofilament suture material used for rectus sheath closure following laparotomy. It provides long-term mechanical support for abdominal wall closure and does not degrade over time. The suture material maintains its tensile strength indefinitely and is known for its high biocompatibility, minimal tissue reaction, and resistance to infection due to its monofilament structure. It is applied using a continuous suturing technique. | Procedure or surgery | Polypropylene (Prolene) Suture for Rectus Sheath Closure |
Primary outcome
Incisional Hernia rate
Time frame: 6 months postoperatively
The primary outcome will assess the rate of incisional hernia at 6 months post-surgery in patients who undergo rectus sheath closure with either Polyglactin 910 (Vicryl) or Polypropylene (Prolene) sutures.
4 secondary outcomes
Surgical Site Infection (SSI) Rate
Time frame: 30 days post-surgery
Suture Sinus Formation
Time frame: 6 months post-surgery
Chronic Pain (Visual Analog Scale, VAS ≥4)
Time frame: 3 months post-surgery
Wound Dehiscence
Time frame: 30 days post-surgery
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 15 Dec 2025.
- Individual participant dataSharing planned: Yes. The individual participant data (IPD) that will be shared includes de-identified demographic information, surgical details, treatment outcomes, and relevant follow-up data (e.g., wound healing, incidence of complications, pain scores, and hernia occurrence). This will provide valuable insight into the comparative efficacy of polyglactin versus polypropylene sutures for rectus sheath closure. The data will be available to qualified researchers after the primary results have been published and the study is concluded.
Related trials for Chronic Pain
Not yet recruiting
Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia
Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy
Not yet recruitingPhase 3
Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT
Chronic Low Back Pain, Musculoskeletal Pain
Not yet recruitingPhase 2
Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain
Chronic Low Back Pain (CLBP), Physical Therapy
Not yet recruiting
Effects of Music During Walking on Pain and Muscle Activation in People With Chronic Pain Due to Knee Osteoarthritis
Knee Osteoarthritis
Not yet recruitingPhase 2/3
PRP Versus NP Injections for Chronic Discogenic Low Back Pain
Discogenic Low Back Pain
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyglactin 910 (Vicryl) Suture and Polypropylene (Prolene) Suture in people with Chronic Pain and Wound Dehiscence, run by Lady Reading Hospital, Pakistan at 1 site in Pakistan.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 15 Dec 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 Pakistan. 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 Dr. Atta Ullah Arif Associate Professor, MBBS, FCPS (+92 333 9126978, attaullah.arif@Irh.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incisional Hernia rate (time frame: 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2025; AzTrials last refreshed its copy on 27 Oct 2026.