When Closing Midline Incisions, do Small Stitches Reduce the Risk for Incisional Hernia, Wound Infection or Dehiscence?

July 27, 2007 updated by: Sundsvall Hospital
The purpose of this study is to determine whether a technique using very small stitches when closing a midline incision can reduce the risk for wound complications such as incisional hernia, infection or dehiscence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Most abdominal surgical operations are made through a midline incision and 10% of the patients may get a wound infection. Infection is a risk factor for incisional hernia, which 12 months after the operation can be seen in 10-20% of the patients. Wound dehiscence is seen in approximately 1% of the patients. Surgery because of incisional hernias are common and in Sweden approximately 2000 patients per year needs an operation creating big costs. We know that a midline incision should be closed using a continuous technique, with a suture length to wound length ratio over 4. An earlier interventional study at the Surgical Department in Sundsvall showed that using that technique reduced the risk for hernia with 50%. Subsequent experimental studies indicates that the suture length to wound length ratio should be obtained by small stitches, placed close to each other only incorporating the aponeurosis, and not by large stitches incorporating the complete abdominal wall (mass closure). The hypothesis that midline incisions should be closed with small stitches only incorporating the aponeurosis has to be tested in a clinical trial.

Study Type

Interventional

Enrollment (Actual)

737

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • 851 86 Sundsvall, Sweden
        • Sundsvall Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patient with an acute or planned operation trough a midline incision at the Surgical Department in Sundsvall, Sweden

Exclusion Criteria:

  • Age under 18
  • Previous surgery through a midline incision
  • Scars from previous surgery crossing the midline
  • Preexisting hernia in the midline (umbilical, epigastric)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Mass closure
Procedure: Mass closure
Experimental: 2
Small stitches
Procedure: Small stitches

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of wound infection
Time Frame: Within the first 30 days after surgery
Within the first 30 days after surgery
Frequency of incisional hernia
Time Frame: One year after surgery
One year after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency of wound dehiscence
Time Frame: Within the first 10 days after surgery
Within the first 10 days after surgery
Effect of different suture techniques on wound complications related to patient characteristics such as age, BMI, sex etc. and operative characteristics such as emergency surgery, type of surgery, degree of contamination, surgeon,etc..
Time Frame: Within 1 year.
Within 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sundsvall Hospital

Investigators

  • Principal Investigator: Daniel Millbourn, MD, Sundsvall Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

July 25, 2007

First Submitted That Met QC Criteria

July 26, 2007

First Posted (Estimate)

July 27, 2007

Study Record Updates

Last Update Posted (Estimate)

July 30, 2007

Last Update Submitted That Met QC Criteria

July 27, 2007

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2-Millbourn

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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