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

This study has been completed.
Sponsor:
Information provided by:
Sundsvall Hospital
ClinicalTrials.gov Identifier:
NCT00508053
First received: July 25, 2007
Last updated: July 27, 2007
Last verified: July 2007

July 25, 2007
July 27, 2007
January 2001
Not Provided
  • Frequency of wound infection [ Time Frame: Within the first 30 days after surgery ]
  • Frequency of incisional hernia [ Time Frame: One year after surgery ]
Same as current
Complete list of historical versions of study NCT00508053 on ClinicalTrials.gov Archive Site
  • Frequency of wound dehiscence [ Time Frame: 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. ]
Same as current
Not Provided
Not Provided
 
When Closing Midline Incisions, do Small Stitches Reduce the Risk for Incisional Hernia, Wound Infection or Dehiscence?
Not Provided

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Wound Infection
  • Incisional Hernia
  • Wound Dehiscence
  • Procedure: Small stitches
  • Procedure: Mass closure
  • Active Comparator: 1
    Mass closure
    Intervention: Procedure: Mass closure
  • Experimental: 2
    Small stitches
    Intervention: Procedure: Small stitches
Millbourn D, Cengiz Y, Israelsson LA. Effect of stitch length on wound complications after closure of midline incisions: a randomized controlled trial. Arch Surg. 2009 Nov;144(11):1056-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
737
July 2007
Not Provided

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00508053
2-Millbourn
No
Not Provided
Sundsvall Hospital
Not Provided
Principal Investigator: Daniel Millbourn, MD Sundsvall Hospital
Sundsvall Hospital
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP