Surgical WoundNCT03801421
Mass Continous Suture With PDS Versus Interrupted Suture With Thread on Major Abdominal Incision
A study testing Mass continous suture with PDS and Interrupted suture with thread in people with Surgical Wound and Suture, Complication, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
A better suture technology will reduce postoperative incision complications. This study is designed to compare mass continous suture with PDS and interrupted suture with thread on major abdominal incision. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Surgical Wound, Suture, Complication
- What is being tested?
- Mass continous suture with PDS and Interrupted suture with thread
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2019to 16 Mar 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the patient with major abdominal incision.
- the incision is longer than 10 cm
- aged between 18 to 65 years old
Who cannot join
- Pregnant woman
- Patient with diabetes
- Patient with a history of cardiovascular disease, including coronary heart disease and stroke.
- Severe lung diseases such as COPD and asthma
- Patients undergoing emergent or infectious surgery
- Patients with surgical site infection
- No autonomy, inability or unwillingness to participate in follow-up
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
About this study
Official title: Mass Continuous Suture With PDS Versus Interrupted Suture With Thread on Major Abdominal Incision: A Randomized Controlled Trial
A better suture technology will reduce postoperative incision complications. This study is designed to compare mass continous suture with PDS and interrupted suture with thread on major abdominal incision.
Read the detailed description
A better suture technology will reduce postoperative incision complications. The previous retrospective cohort study from the investigator has demonstrated that continuous mass suture with PDS led to shorter incision closure time, early wound healing and comparable incisional complications versus interrupted thread suture. As such, the current RCT study will include 100 subjects with major abdominal incision. They will be divided into two groups randomly: Mass suture gorup, mass continuous suture with PDS, Control group, interrupted suture with thread. The wound healing time, stitches removal time and incidence of incision complications will be compared between the two groups.
- Conditions
- Surgical Wound, Suture, Complication
- Being tested
- Mass continous suture with PDS, Interrupted suture with thread
- Keywords
- Surgical Wound, Suture, Complication
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mass continous suture with PDSProcedure or surgery
The surgical incision will be treated by mass continous suture with PDS.
Interrupted suture with threadProcedure or surgery
The surgical incision will be treated by interrupted suture with thread.
| Study group | Role | What they receive |
|---|---|---|
| Continous suture group | Experimental | The surgical incision will be treated by mass continous suture with PDS. Receives: Procedure: Mass continous suture with PDS |
| Control group | Active comparator | The surgical incision will be treated by interrupted suture with thread. Receives: Procedure: Interrupted suture with thread |
What is being measured
The primary outcome is the main question the study is designed to answer.
healing time, d (day)
Time duration between the date of surgery to the date of stitches off
Measured: Up to 1 month after surgery
Secondary outcomes (1)
incidence of incision complications
The incision complications include infection, dehiscence, fat liquefaction, and so on.
Measured: Up to 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start1 Feb 2019
- Primary completion16 Mar 2021
- Study completion16 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical WoundStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Xu-Feng, First Affiliated Hospital Xi'an Jiaotong University
- Investigators
- Xu-Feng Zhang, MD, PhD, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801421
- Sponsor's protocol ID
- XJTU1AFCRC2017SJ-007-2
- Status last verified
- May 2021
- First submitted
- 6 Jan 2019
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mass Continuous Suture With PDS Versus Interrupted Suture With Thread on Major Abdominal Incision: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03801421
- Acronym / sponsor ID
- XJTU1AFCRC2017SJ-007-2
- Conditions
- Surgical Wound, Suture, Complication
- Keywords
- Surgical Wound, Suture, Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 16 Mar 2021 (actual)
- Study completion
- 16 Mar 2021 (actual)
- First posted
- 11 Jan 2019 (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.
A better suture technology will reduce postoperative incision complications. This study is designed to compare mass continous suture with PDS and interrupted suture with thread on major abdominal incision.
Detailed description
A better suture technology will reduce postoperative incision complications. The previous retrospective cohort study from the investigator has demonstrated that continuous mass suture with PDS led to shorter incision closure time, early wound healing and comparable incisional complications versus interrupted thread suture. As such, the current RCT study will include 100 subjects with major abdominal incision. They will be divided into two groups randomly: Mass suture gorup, mass continuous suture with PDS, Control group, interrupted suture with thread. The wound healing time, stitches removal time and incidence of incision complications will be compared between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continous suture group | Experimental | Procedure: Mass continous suture with PDSThe surgical incision will be treated by mass continous suture with PDS. |
| Control group | Active comparator | Procedure: Interrupted suture with threadThe surgical incision will be treated by interrupted suture with thread. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- the patient with major abdominal incision.
- the incision is longer than 10 cm
- aged between 18 to 65 years old
Key exclusion criteria (7 listed)
- Pregnant woman
- Patient with diabetes
- Patient with a history of cardiovascular disease, including coronary heart disease and stroke.
- Severe lung diseases such as COPD and asthma
- Patients undergoing emergent or infectious surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mass continous suture with PDSThe surgical incision will be treated by mass continous suture with PDS. | Procedure or surgery | Continous suture group |
| Interrupted suture with threadThe surgical incision will be treated by interrupted suture with thread. | Procedure or surgery | Control group |
Primary outcome
healing time, d (day)
Time frame: Up to 1 month after surgery
Time duration between the date of surgery to the date of stitches off
1 secondary outcome
incidence of incision complications
Time frame: Up to 1 month after 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 19 May 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.
Xu-Feng Zhang, MD, PhD principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mass continous suture with PDS and Interrupted suture with thread in people with Surgical Wound and Suture, Complication, 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 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: finished, as of the sponsor's last update on 19 May 2021. 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?
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?
healing time, d (day) (time frame: Up to 1 month after surgery). 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 19 May 2021.