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.
Procedure: Small stitches
Procedure: Mass closure
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
- Frequency of wound infection [ Time Frame: Within the first 30 days after surgery ]
- Frequency of incisional hernia [ Time Frame: One year after surgery ]
- 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. ]
|Study Start Date:||January 2001|
|Study Completion Date:||July 2007|
Active Comparator: 1
|Procedure: Mass closure|
|Procedure: Small stitches|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00508053
|851 86 Sundsvall, Sweden|
|Principal Investigator:||Daniel Millbourn, MD||Sundsvall Hospital|