Mass Continous Suture With PDS Versus Interrupted Suture With Thread on Major Abdominal Incision

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mass Continuous Suture With PDS Versus Interrupted Suture With Thread on Major Abdominal Incision: A Randomized Controlled Trial

Conditions
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Surgical Wound, Suture, Complication

Intervention / Treatment
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* Procedure: Mass continous suture with PDS
* Procedure: Interrupted suture with thread


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continous suture group<br>The surgical incision will be treated by mass continous suture with PDS. | Procedure: Mass continous suture with PDS<br>* The surgical incision will be treated by mass continous suture with PDS.<br>|
| Active Comparator: Control group<br>The surgical incision will be treated by interrupted suture with thread. | Procedure: Interrupted suture with thread<br>* The surgical incision will be treated by interrupted suture with thread.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| healing time, d (day) | 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 | The incision complications include infection, dehiscence, fat liquefaction, and so on. | Up to 1 month after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical Wound, Suture, Complication