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CompletedNCT03801421Updated May 19, 2021

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

An interventional study of Mass continous suture with PDS and Interrupted suture with thread in Surgical Wound and Suture, Complication, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-05-19.

Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
2,000
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Surgical Wound
  • Suture, Complication

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Keywords

  • Surgical Wound
  • Suture, Complication
03

In context

Surgical Wound

519 studies on the registry are indexed under Surgical Wound; 71 are open to participants now.

This study's enrollment of 2,000 is above the median of 80 across 412 interventional studies indexed under Surgical Wound.

Browse Surgical Wound studies →

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 306 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • the patient with major abdominal incision.
  • the incision is longer than 10 cm
  • aged between 18 to 65 years old

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,000 participants (actual)

Study arms

  • Experimental
    Continous suture group

    The surgical incision will be treated by mass continous suture with PDS.

    Procedure: Mass continous suture with PDS

  • Active comparator
    Control group

    The surgical incision will be treated by interrupted suture with thread.

    Procedure: Interrupted suture with thread

Interventions

  • ProcedureMass continous suture with PDS

    The surgical incision will be treated by mass continous suture with PDS.

  • ProcedureInterrupted suture with thread

    The surgical incision will be treated by interrupted suture with thread.

06

What researchers measure

Primary outcomes

  1. healing time, d (day)

    Time duration between the date of surgery to the date of stitches off

    Time frame: Up to 1 month after surgery

Secondary outcomes

  1. incidence of incision complications

    The incision complications include infection, dehiscence, fat liquefaction, and so on.

    Time frame: Up to 1 month after surgery

07

Study locations

1 site
  • The First Affiliated Hospital of Xi'an Jiaotong University
    Xi'an, Shaanxi 710061, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03801421
Lead sponsor
First Affiliated Hospital Xi'an Jiaotong University
Responsible party
Zhang Xu-Feng (Professor, First Affiliated Hospital Xi'an Jiaotong University) — Principal investigator
First posted
Jan 11, 2019
Start date
Feb 1, 2019
Primary completion
Mar 16, 2021
Completion
Mar 16, 2021
Last update
May 19, 2021

Study contacts

Xu-Feng Zhang, MD, PhD
principal investigator · First Affiliated Hospital Xi'an Jiaotong University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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