- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03801421
Mass Continous Suture With PDS Versus Interrupted Suture With Thread on Major Abdominal Incision
May 18, 2021 updated by: Zhang Xu-Feng, First Affiliated Hospital Xi'an Jiaotong University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
2000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710061
- The First Affiliated Hospital of Xi'an Jiaotong University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- the patient with major abdominal incision.
- the incision is longer than 10 cm
- aged between 18 to 65 years old
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Continous suture group
The surgical incision will be treated by mass continous suture with PDS.
|
The surgical incision will be treated by mass continous suture with PDS.
|
Active Comparator: Control group
The surgical incision will be treated by interrupted suture with thread.
|
The surgical incision will be treated by interrupted suture with thread.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Up to 1 month after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of incision complications
Time Frame: Up to 1 month after surgery
|
The incision complications include infection, dehiscence, fat liquefaction, and so on.
|
Up to 1 month after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xu-Feng Zhang, MD, PhD, First Affiliated Hospital Xi'an Jiaotong University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2019
Primary Completion (Actual)
March 16, 2021
Study Completion (Actual)
March 16, 2021
Study Registration Dates
First Submitted
January 6, 2019
First Submitted That Met QC Criteria
January 10, 2019
First Posted (Actual)
January 11, 2019
Study Record Updates
Last Update Posted (Actual)
May 19, 2021
Last Update Submitted That Met QC Criteria
May 18, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- XJTU1AFCRC2017SJ-007-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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