CicatrixNCT05787171
Three Sutures With Different Absorption Rates for Lower Abdominal Incision
A study testing WE-MBVMS using suture Vicryl (Polyglactin 910; Johnson & Johnson International, USA);, WE-MBVMS using suture PDS (polydioxanone; Johnson & Johnson International, USA) and WE-MBVMS using suture Ethibond (polyester; Johnson & Johnson International, USA） in people with Cicatrix, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
The previous studies have demonstrated that wedge excision combined modified buried vertical mattress suture (WE-MBVMS) provides better aesthetic outcomes than traditional ways. Prolonged tension reduction is crucial in WE-MBVMS suppressing scar, while suture used during WE-MBVMS decided the length of tension reducing… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cicatrix
- What is being tested?
- WE-MBVMS using suture Vicryl (Polyglactin 910; Johnson & Johnson International, USA);, WE-MBVMS using suture PDS (polydioxanone; Johnson & Johnson International, USA) and WE-MBVMS using suture Ethibond (polyester; Johnson & Johnson International, USA）
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 31 Oct 2023
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- surgical incisions need to be closed after skin gotten;
- incisions at least 10 cm in length;
- patients aged between18 and 60 years old.
Who cannot join
- chronic diseases, like diabetes, chronic kidney disease, malignant neoplasms and severe malnutrition;
- pregnancy;
- inability to return for the follow-up visit;
- unwillingness to provide informed consent;
- inability to read or speak Chinese.
Trial locations and contacts
1 site in 1 country.
Jing Jia contact
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Xinxi Zhu, 0086-18127051613, zhuxinxi1998@stu.xjtu.edu.cn
Maoguo Shu, 0086-13384962722
About this study
Official title: A Prospective Study to Compare the Cosmetic Results of Sutures With Different Absorption Rates for Lower Abdominal Incision
The previous studies have demonstrated that wedge excision combined modified buried vertical mattress suture (WE-MBVMS) provides better aesthetic outcomes than traditional ways. Prolonged tension reduction is crucial in WE-MBVMS suppressing scar, while suture used during WE-MBVMS decided the length of tension reducing time to a certain degree. However, presently surgeons select suture for WE-MBVMS mostly according to their personal preference and clinical experience and clinical comparative evidence exposing the best suture for desired cosmetic outcome is lacking. Here, investigators purposed to establish a feasibility trial comparing the scars left by WE-MBVMS using sutures with different tension holding time.
This is a feasibility, single-center RCT with 35 patients aiming to compare the scar of the hypogastric incision sutured by three different-absorption-rate sutures with WE-MBVMS. The incision induced by donating skin grafts is evenly divided into three segments, each segment randomly uses one of three different sutures randomly allocated by the SAS (V.9.4) statistical software. The feasibility of this study will be assessed by the primary outcomes, including patient and clinician enrolment refusal as well as their reasons, reasons for ineligibility, recruitment ratio, retention and withdrawal at each follow-up point (1, 3, and 6 months), reasons for withdrawal, integrity of collected data and adverse event rates. Secondary outcome measures of the cosmetic outcome of scar will help shape future fully powered RCT by formulating the sample size.
Read the detailed description
Data from clinical trial and the previous study have demonstrated that wedge excision combined modified buried vertical mattress suture (WE-MBVMS) provides better aesthetic outcomes than traditional ways. As an effectively tension reducing, precisely edge everting and easily performing technique, WE-MBVMS has the following characteristics distinguishing it from other methods: (1) The edge of the incision was excised in a wedge size to guarantee a fully eversion in the edges of the incision; (2) And the stitch embed in the dermis as long as possible to recruit dermal tissue as much as possible in the suture loop, from which a sufficient skin eversion accompanied with visible skin folds is formed.
After the above operation, tension of the incision is effectively reduced and reserved to antagonist the consistently existing tension for a certain time, which is the core of WE-MBVMS in inducing slight scars. Although WE-MBVMS possesses the ability of confronting tension for a long time, the absorbable suture used during the WE-MBVMS decided the length of the tension reserving time. It is known that the period of scar molding is as long as 6-12 months, during which tension reducing contributes a lot in scar suppression. Hence, selecting appropriate material for the WE-MBVMS to achieve enough support for tension reducing of the incision might consequently lead to ideal scar suppression.
Nowadays, various kinds of absorbable sutures can be used in intradermal suture, among which PDS™ (polydioxanone) and Vicryl™ (polyglactin) is most commonly used. With the tension holding time of 90 days and 30 days, respectively, it is easy to relate them to different scar suppressing ability. Considering the crucial role of reducing tension played in suppressing scar and that nonabsorbable suture, also used in intradermal suture, provide prolonged dermal support, the researchers also employed polyester nonabsorbable suture in the WE-MBVMS . Although the ability of polyester suture in reducing tension will not be disturbed by its broken down by the body, tissue cutting and displacement will happen under the continuous action of external force over time. It follows that the efficiency of tension reduction and tissue eversion brought by polyester is prolonged but not permanent.
In this study, the lower abdominal incision will be selected which induced by harvesting autogenous skin grafts for wound repair to perform the comparison of the above three sutures. Because the donation causes incision, which leaves scar in the donor site that is mostly neglected by surgeons but concerned by patients. Besides, the hypogastrium is one of the important aesthetic units, thus scar is aesthetically undesirable or symptomatic8. Moreover, autogenous hypogastric skin graft, as an important skin donor site, is commonly used by plastic surgeons. Through comparing the cosmetic results of scars achieved by materials with different tension holding time, the researchers will further understand the duration of tension-reduction required for optimal scar inhibition and get a reference for suture selection. Taken together, a feasibility trial is required to produce more evidence for a fully powered randomised controlled trial (RCT).
This is a feasibility, single-center RCT with 35 patients aiming to compare the scar of the hypogastric incision sutured by three different-absorption-rate sutures with WE-MBVMS. The incision induced by donating skin grafts is evenly divided into three segments, each segment randomly uses one of three different sutures randomly allocated by the SAS (V.9.4) statistical software. The feasibility of this study will be assessed by the primary outcomes, including patient and clinician enrolment refusal as well as their reasons, reasons for ineligibility, recruitment ratio, retention and withdrawal at each follow-up point (1, 3, and 6 months), reasons for withdrawal, integrity of collected data and adverse event rates. Secondary outcome measures of the cosmetic outcome of scar will help shape future fully powered RCT by formulating the sample size.
- Conditions
- Cicatrix
- Being tested
- WE-MBVMS using suture Vicryl (Polyglactin 910; Johnson & Johnson International, USA);, WE-MBVMS using suture PDS (polydioxanone; Johnson & Johnson International, USA), WE-MBVMS using suture Ethibond (polyester; Johnson & Johnson International, USA）
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WE-MBVMS using suture Vicryl (Polyglactin 910; Johnson & Johnson International, USA);Device
The skin around the incision is dissociated from the bottom, followed by measuring the length of the wound and dividing it into three segments evenly. Each segment randomly received 2-0 Vicryl suture, 2-0 PDS suture, or 2-0 Ethibond suture to sew up the incision with WE-MBVMS.
WE-MBVMS using suture PDS (polydioxanone; Johnson & Johnson International, USA)Device
The skin around the incision is dissociated from the bottom, followed by measuring the length of the wound and dividing it into three segments evenly. Each segment randomly received 2-0 Vicryl suture, 2-0 PDS suture, or 2-0 Ethibond suture to sew up the incision with WE-MBVMS.
WE-MBVMS using suture Ethibond (polyester; Johnson & Johnson International, USA）Device
The skin around the incision is dissociated from the bottom, followed by measuring the length of the wound and dividing it into three segments evenly. Each segment randomly received 2-0 Vicryl suture, 2-0 PDS suture, or 2-0 Ethibond suture to sew up the incision with WE-MBVMS.
| Study group | Role | What they receive |
|---|---|---|
| PDS group | Experimental | The skin around the incision is dissociated from the bottom, followed by measuring the length of the wound and dividing it into three segments evenly. Each segment randomly received 2-0 Vicryl suture, 2-0 PDS suture, or 2-0 Ethibond suture to sew up the incision with WE-MBVMS. This is the group which received 2-0 PDS suture to sew up the incision. Receives: Device: WE-MBVMS using suture PDS (polydioxanone; Johnson & Johnson International, USA) |
| Vicryl group | Experimental | The skin around the incision is dissociated from the bottom, followed by measuring the length of the wound and dividing it into three segments evenly. Each segment randomly received 2-0 Vicryl suture, 2-0 PDS suture, or 2-0 Ethibond suture to sew up the incision with WE-MBVMS.This is the group which received 2-0 Vicryl suture to sew up the incision. Receives: Device: WE-MBVMS using suture Vicryl (Polyglactin 910; Johnson & Johnson International, USA); |
| Ethibond group | Experimental | The skin around the incision is dissociated from the bottom, followed by measuring the length of the wound and dividing it into three segments evenly. Each segment randomly received 2-0 Vicryl suture, 2-0 PDS suture, or 2-0 Ethibond suture to sew up the incision with WE-MBVMS.This is the group which received 2-0 Ethibond suture to sew up the incision. Receives: Device: WE-MBVMS using suture Ethibond (polyester; Johnson & Johnson International, USA） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
As a 10cm line with 0 presenting the worst and 10 presenting the best overall satisfaction, the score of VAS is collected by patients placing a vertical mark on the VAS.
Measured: 1 month after the surgery
Visual Analogue Scale (VAS)
As a 10cm line with 0 presenting the worst and 10 presenting the best overall satisfaction, the score of VAS is collected by patients placing a vertical mark on the VAS.
Measured: 3 month after the surgery
Visual Analogue Scale (VAS)
As a 10cm line with 0 presenting the worst and 10 presenting the best overall satisfaction, the score of VAS is collected by patients placing a vertical mark on the VAS.
Measured: 6 month after the surgery
Patient Scar Assessment Scale (PSAS)
Six domains including pain, itching, colour, pliability, thickness and relief, are contained in the PSAS.
Measured: 1 month after the surgery
Patient Scar Assessment Scale (PSAS)
Six domains including pain, itching, colour, pliability, thickness and relief, are contained in the PSAS.
Measured: 3 month after the surgery
Patient Scar Assessment Scale (PSAS)
Six domains including pain, itching, colour, pliability, thickness and relief, are contained in the PSAS.
Measured: 6 month after the surgery
Observer Scar Assessment Scale (OSAS)
Six domains including pain, itching, colour, pliability, thickness and relief, are contained in the OSAS.
Measured: 1 month after the surgery
Observer Scar Assessment Scale (OSAS)
Six domains including pain, itching, colour, pliability, thickness and relief, are contained in the OSAS.
Measured: 3 month after the surgery
Observer Scar Assessment Scale (OSAS)
Six domains including pain, itching, colour, pliability, thickness and relief, are contained in the OSAS.
Measured: 6 month after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start1 Nov 2022
- Primary completion1 Jul 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CicatrixStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787171
- Sponsor's protocol ID
- XJTU1AF2021CRF-019
- Status last verified
- Oct 2022
- First submitted
- 25 Aug 2022
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Compare the Cosmetic Results of Sutures With Different Absorption Rates for Lower Abdominal Incision
- ClinicalTrials.gov ID
- NCT05787171
- Acronym / sponsor ID
- XJTU1AF2021CRF-019
- Conditions
- Cicatrix
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 28 Mar 2023 (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.
The previous studies have demonstrated that wedge excision combined modified buried vertical mattress suture (WE-MBVMS) provides better aesthetic outcomes than traditional ways. Prolonged tension reduction is crucial in WE-MBVMS suppressing scar, while suture used during WE-MBVMS decided the length of tension reducing time to a certain degree. However, presently surgeons select suture for WE-MBVMS mostly according to their personal preference and clinical experience and clinical comparative evidence exposing the best suture for desired cosmetic outcome is lacking. Here, investigators purposed to establish a feasibility trial comparing the scars left by WE-MBVMS using sutures with different tension holding time.
This is a feasibility, single-center RCT with 35 patients aiming to compare the scar of the hypogastric incision sutured by three different-absorption-rate sutures with WE-MBVMS. The incision induced by donating skin grafts is evenly divided into three segments, each segment randomly uses one of three different sutures randomly allocated by the SAS (V.9.4) statistical software. The feasibility of this study will be assessed by the primary outcomes, including patient and clinician enrolment refusal as well as their reasons, reasons for ineligibility, recruitment ratio, retention and withdrawal at each follow-up point (1, 3, and 6 months), reasons for withdrawal, integrity of collected data and adverse event rates. Secondary outcome measures of the cosmetic outcome of scar will help shape future fully powered RCT by formulating the sample size.
Detailed description
Data from clinical trial and the previous study have demonstrated that wedge excision combined modified buried vertical mattress suture (WE-MBVMS) provides better aesthetic outcomes than traditional ways. As an effectively tension reducing, precisely edge everting and easily performing technique, WE-MBVMS has the following characteristics distinguishing it from other methods: (1) The edge of the incision was excised in a wedge size to guarantee a fully eversion in the edges of the incision; (2) And the stitch embed in the dermis as long as possible to recruit dermal tissue as much as possible in the suture loop, from which a sufficient skin eversion accompanied with visible skin folds is formed.
After the above operation, tension of the incision is effectively reduced and reserved to antagonist the consistently existing tension for a certain time, which is the core of WE-MBVMS in inducing slight scars. Although WE-MBVMS possesses the ability of confronting tension for a long time, the absorbable suture used during the WE-MBVMS decided the length of the tension reserving time. It is known that the period of scar molding is as long as 6-12 months, during which tension reducing contributes a lot in scar suppression. Hence, selecting appropriate material for the WE-MBVMS to achieve enough support for tension reducing of the incision might consequently lead to ideal scar suppression.
Nowadays, various kinds of absorbable sutures can be used in intradermal suture, among which PDS™ (polydioxanone) and Vicryl™ (polyglactin) is most commonly used. With the tension holding time of 90 days and 30 days, respectively, it is easy to relate them to different scar suppressing ability. Considering the crucial role of reducing tension played in suppressing scar and that nonabsorbable suture, also used in intradermal suture, provide prolonged dermal support, the researchers also employed polyester nonabsorbable suture in the WE-MBVMS . Although the ability of polyester suture in reducing tension will not be disturbed by its broken down by the body, tissue cutting and displacement will happen under the continuous action of external force over time. It follows that the efficiency of tension reduction and tissue eversion brought by polyester is prolonged but not permanent.
In this study, the lower abdominal incision will be selected which induced by harvesting autogenous skin grafts for wound repair to perform the comparison of the above three sutures. Because the donation causes incision, which leaves scar in the donor site that is mostly neglected by surgeons but concerned by patients. Besides, the hypogastrium is one of the important aesthetic units, thus scar is aesthetically undesirable or symptomatic8. Moreover, autogenous hypogastric skin graft, as an important skin donor site, is commonly used by plastic surgeons. Through comparing the cosmetic results of scars achieved by materials with different tension holding time, the researchers will further understand the duration of tension-reduction required for optimal scar inhibition and get a reference for suture selection. Taken together, a feasibility trial is required to produce more evidence for a fully powered randomised controlled trial (RCT).
This is a feasibility, single-center RCT with 35 patients aiming to compare the scar of the hypogastric incision sutured by three different-absorption-rate sutures with WE-MBVMS. The incision induced by donating skin grafts is evenly divided into three segments, each segment randomly uses one of three different sutures randomly allocated by the SAS (V.9.4) statistical software. The feasibility of this study will be assessed by the primary outcomes, including patient and clinician enrolment refusal as well as their reasons, reasons for ineligibility, recruitment ratio, retention and withdrawal at each follow-up point (1, 3, and 6 months), reasons for withdrawal, integrity of collected data and adverse event rates. Secondary outcome measures of the cosmetic outcome of scar will help shape future fully powered RCT by formulating the sample size.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PDS group | Experimental | Device: WE-MBVMS using suture PDS (polydioxanone; Johnson & Johnson International, USA)The skin around the incision is dissociated from the bottom, followed by measuring the length of the wound and dividing it into three segments evenly. Each segment randomly received 2-0 Vicryl suture, 2-0 PDS suture, or 2-0 Ethibond suture to sew up the incision with WE-MBVMS. This is the group which received 2-0 PDS suture to sew up the incision. |
| Vicryl group | Experimental | Device: WE-MBVMS using suture Vicryl (Polyglactin 910; Johnson & Johnson International, USA);The skin around the incision is dissociated from the bottom, followed by measuring the length of the wound and dividing it into three segments evenly. Each segment randomly received 2-0 Vicryl suture, 2-0 PDS suture, or 2-0 Ethibond suture to sew up the incision with WE-MBVMS.This is the group which received 2-0 Vicryl suture to sew up the incision. |
| Ethibond group | Experimental | Device: WE-MBVMS using suture Ethibond (polyester; Johnson & Johnson International, USA）The skin around the incision is dissociated from the bottom, followed by measuring the length of the wound and dividing it into three segments evenly. Each segment randomly received 2-0 Vicryl suture, 2-0 PDS suture, or 2-0 Ethibond suture to sew up the incision with WE-MBVMS.This is the group which received 2-0 Ethibond suture to sew up the incision. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- surgical incisions need to be closed after skin gotten;
- incisions at least 10 cm in length;
- patients aged between18 and 60 years old.
Key exclusion criteria (5 listed)
- chronic diseases, like diabetes, chronic kidney disease, malignant neoplasms and severe malnutrition;
- pregnancy;
- inability to return for the follow-up visit;
- unwillingness to provide informed consent;
- inability to read or speak Chinese.
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 |
|---|---|---|
| WE-MBVMS using suture Vicryl (Polyglactin 910; Johnson & Johnson International, USA);The skin around the incision is dissociated from the bottom, followed by measuring the length of the wound and dividing it into three segments evenly. Each segment randomly received 2-0 Vicryl suture, 2-0 PDS suture, or 2-0 Ethibond suture to sew up the incision with WE-MBVMS. | Device | Vicryl group |
| WE-MBVMS using suture PDS (polydioxanone; Johnson & Johnson International, USA)The skin around the incision is dissociated from the bottom, followed by measuring the length of the wound and dividing it into three segments evenly. Each segment randomly received 2-0 Vicryl suture, 2-0 PDS suture, or 2-0 Ethibond suture to sew up the incision with WE-MBVMS. | Device | PDS group |
| WE-MBVMS using suture Ethibond (polyester; Johnson & Johnson International, USA）The skin around the incision is dissociated from the bottom, followed by measuring the length of the wound and dividing it into three segments evenly. Each segment randomly received 2-0 Vicryl suture, 2-0 PDS suture, or 2-0 Ethibond suture to sew up the incision with WE-MBVMS. | Device | Ethibond group |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: 1 month after the surgery
As a 10cm line with 0 presenting the worst and 10 presenting the best overall satisfaction, the score of VAS is collected by patients placing a vertical mark on the VAS.
Visual Analogue Scale (VAS)
Time frame: 3 month after the surgery
As a 10cm line with 0 presenting the worst and 10 presenting the best overall satisfaction, the score of VAS is collected by patients placing a vertical mark on the VAS.
Visual Analogue Scale (VAS)
Time frame: 6 month after the surgery
As a 10cm line with 0 presenting the worst and 10 presenting the best overall satisfaction, the score of VAS is collected by patients placing a vertical mark on the VAS.
Patient Scar Assessment Scale (PSAS)
Time frame: 1 month after the surgery
Six domains including pain, itching, colour, pliability, thickness and relief, are contained in the PSAS.
Patient Scar Assessment Scale (PSAS)
Time frame: 3 month after the surgery
Six domains including pain, itching, colour, pliability, thickness and relief, are contained in the PSAS.
Patient Scar Assessment Scale (PSAS)
Time frame: 6 month after the surgery
Six domains including pain, itching, colour, pliability, thickness and relief, are contained in the PSAS.
Observer Scar Assessment Scale (OSAS)
Time frame: 1 month after the surgery
Six domains including pain, itching, colour, pliability, thickness and relief, are contained in the OSAS.
Observer Scar Assessment Scale (OSAS)
Time frame: 3 month after the surgery
Six domains including pain, itching, colour, pliability, thickness and relief, are contained in the OSAS.
Observer Scar Assessment Scale (OSAS)
Time frame: 6 month after the surgery
Six domains including pain, itching, colour, pliability, thickness and relief, are contained in the OSAS.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- 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.
Jing Jia contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WE-MBVMS using suture Vicryl (Polyglactin 910; Johnson & Johnson International, USA);, WE-MBVMS using suture PDS (polydioxanone; Johnson & Johnson International, USA) and WE-MBVMS using suture Ethibond (polyester; Johnson & Johnson International, USA） in people with Cicatrix, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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 3 inclusion and 5 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 28 Mar 2023. 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 China. 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 Xinxi Zhu (0086-18127051613, zhuxinxi1998@stu.xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: 1 month after the surgery). The study lists 9 primary outcomes in all. 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 28 Mar 2023.