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Completed

NCT Number: NCT03801421

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

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.

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Key information

Conditions

Surgical Wound Suture, Complication Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mass continous suture with PDS

Procedure

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

Interrupted suture with thread

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. incidence of incision complications

    Time frame: Up to 1 month after surgery

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

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 11, 2019
Registry last updated
May 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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