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

Wound Infection Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00508053
• Other study ID #: 2-Millbourn
• Status: Completed
• Phase: N/A
• First received: July 25, 2007
• Last updated: July 27, 2007
• Start date: January 2001
• Est. completion date: July 2007

Study information

• Verified date: July 2007
• Source: Sundsvall Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 737
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia
• Infection
• Wound Dehiscence
• Wound Infection

Intervention

Procedure:
• Small stitches

• Mass closure

Locations

Country	Name	City	State
Sweden	Sundsvall Hospital	851 86 Sundsvall

Sponsors (1)

Lead Sponsor	Collaborator
Sundsvall Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of wound infection		Within the first 30 days after surgery
Primary	Frequency of incisional hernia		One year after surgery
Secondary	Frequency of wound dehiscence		Within the first 10 days after surgery
Secondary	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.