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

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Xi'an Jiaotong University

Status

Completed

Conditions

Surgical Wound
Suture, Complication

Treatments

Procedure: Interrupted suture with thread
Procedure: Mass continous suture with PDS

Study type

Interventional

Funder types

Other

Identifiers

NCT03801421
XJTU1AFCRC2017SJ-007-2

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,000 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

2,000 participants in 2 patient groups

Continous suture group
Experimental group
Description:
The surgical incision will be treated by mass continous suture with PDS.
Treatment:
Procedure: Mass continous suture with PDS
Control group
Active Comparator group
Description:
The surgical incision will be treated by interrupted suture with thread.
Treatment:
Procedure: Interrupted suture with thread

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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