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

NCT ID: NCT00508053

Last Updated: 2007-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

737 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2007-07-31

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

Keywords

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wound infection incisional hernia wound dehiscence wound healing postoperative complications surgical techniques

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Study Groups

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1

Mass closure

Group Type ACTIVE_COMPARATOR

Mass closure

Intervention Type PROCEDURE

2

Small stitches

Group Type EXPERIMENTAL

Small stitches

Intervention Type PROCEDURE

Interventions

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Small stitches

Intervention Type PROCEDURE

Mass closure

Intervention Type PROCEDURE

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sundsvall Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Daniel Millbourn, MD

Role: PRINCIPAL_INVESTIGATOR

Sundsvall Hospital

Locations

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Sundsvall Hospital

851 86 Sundsvall, , Sweden

Site Status

Countries

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Sweden

References

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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. doi: 10.1001/archsurg.2009.189.

Reference Type DERIVED
PMID: 19917943 (View on PubMed)

Other Identifiers

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2-Millbourn

Identifier Type: -

Identifier Source: org_study_id