When Closing Midline Incisions, do Small Stitches Reduce the Risk for Incisional Hernia, Wound Infection or Dehiscence?
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Wound Infection Incisional Hernia Wound Dehiscence |
Procedure: Small stitches Procedure: Mass closure |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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. ]
| Enrollment: | 737 |
| Study Start Date: | January 2001 |
| Study Completion Date: | July 2007 |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Mass closure
|
Procedure: Mass closure |
|
Experimental: 2
Small stitches
|
Procedure: Small stitches |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
More Information
No publications provided by Sundsvall Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00508053 History of Changes |
| Other Study ID Numbers: | 2-Millbourn |
| Study First Received: | July 25, 2007 |
| Last Updated: | July 27, 2007 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Keywords provided by Sundsvall Hospital:
|
wound infection incisional hernia wound dehiscence |
wound healing postoperative complications surgical techniques |
Additional relevant MeSH terms:
|
Hernia Wound Infection Pathological Conditions, Anatomical Infection Wounds and Injuries |
ClinicalTrials.gov processed this record on May 16, 2013