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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03801421
Other study ID # XJTU1AFCRC2017SJ-007-2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2019
Est. completion date March 16, 2021

Study information

Verified date May 2021
Source First Affiliated Hospital Xi'an Jiaotong University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 2000
Est. completion date March 16, 2021
Est. primary completion date March 16, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Mass continous suture with PDS
The surgical incision will be treated by mass continous suture with PDS.
Interrupted suture with thread
The surgical incision will be treated by interrupted suture with thread.

Locations

Country Name City State
China The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary healing time, d (day) Time duration between the date of surgery to the date of stitches off Up to 1 month after surgery
Secondary incidence of incision complications The incision complications include infection, dehiscence, fat liquefaction, and so on. Up to 1 month after surgery
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