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

Not Applicable

Completed

• Conditions: Wound Infection; Incisional Hernia; Wound Dehiscence
• Interventions: Procedure: Mass closure; Procedure: Small stitches

• Registration Number: NCT00508053
• Lead Sponsor: Sundsvall Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2001-01
• Status Verified: 2007-07
• Study Completion: 2007-07
• Study First Submitted: 2007-07-25
• Study First Submitted QC: 2007-07-26
• Study First Posted: 2007-07-27
• Last Update Submitted: 2007-07-27
• Last Update Posted: 2007-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 737

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Mass closure	Mass closure
2	Small stitches	Small stitches

Primary Outcome Measures

Name	Time	Method
Frequency of wound infection	Within the first 30 days after surgery
Frequency of incisional hernia	One year after surgery

Secondary Outcome Measures

Name	Time	Method
Frequency of wound dehiscence	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..	Within 1 year.

Trial Locations

Locations (1)

Sundsvall Hospital; 🇸🇪 851 86 Sundsvall, Sweden