Skip to main content
OpenTrials
Completed

NCT Number: NCT00508053

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sundsvall Hospital

851 86 Sundsvall, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Small stitches

Procedure

Mass closure

Procedure

Primary outcomes

  1. Frequency of wound infection

    Time frame: Within the first 30 days after surgery

  2. Frequency of incisional hernia

    Time frame: One year after surgery

Secondary outcomes

  1. Frequency of wound dehiscence

    Time frame: Within the first 10 days after surgery

  2. 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.

Sponsors and collaborators

Lead sponsor

Sundsvall Hospital

Other

Registry information

Important dates

Study start
2001
Study completion
2007
First posted
Jul 27, 2007
Registry last updated
Jul 30, 2007

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.

Published trials that share one or more normalized conditions with this study.