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

Study Overview
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Brief Summary
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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
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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.

Conditions
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Wound Infection, Incisional Hernia, Wound Dehiscence

Intervention / Treatment
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* Procedure: Small stitches
* Procedure: Mass closure


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Mass closure | Procedure: Mass closure<br> <br> |
| Experimental: 2<br>Small stitches | Procedure: Small stitches<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of wound infection |  | Within the first 30 days after surgery | 
| Frequency of incisional hernia |  | One year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wound infection, incisional hernia, wound dehiscence, wound healing, postoperative complications, surgical techniques