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Sponsored by: |
Sundsvall Hospital |
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Information provided by: | Sundsvall Hospital |
ClinicalTrials.gov Identifier: | NCT00508053 |
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 |
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Wound Infection Incisional Hernia Wound Dehiscence |
Procedure: Small stitches Procedure: Mass closure |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Enrollment: | 737 |
Study Start Date: | January 2001 |
Study Completion Date: | July 2007 |
Arms | Assigned Interventions |
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1: Active Comparator
Mass closure
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Procedure: Mass closure |
2: Experimental
Small stitches
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 2-Millbourn |
Study First Received: | July 25, 2007 |
Last Updated: | July 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00508053 |
Health Authority: | Sweden: Regional Ethical Review Board |
wound infection incisional hernia wound dehiscence |
wound healing postoperative complications surgical techniques |
Pathological Conditions, Anatomical Postoperative Complications Hernia |
Wounds and Injuries Disorders of Environmental Origin Wound Infection |
Communicable Diseases Infection |