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

Primary Purpose

Wound Infection, Incisional Hernia, Wound Dehiscence

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Small stitches
Mass closure
Sponsored by
Sundsvall Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Wound Infection focused on measuring wound infection, incisional hernia, wound dehiscence, wound healing, postoperative complications, surgical techniques

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Sundsvall Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Mass closure

Small stitches

Outcomes

Primary Outcome Measures

Frequency of wound infection
Frequency of incisional hernia

Secondary Outcome Measures

Frequency of wound dehiscence
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..

Full Information

First Posted
July 25, 2007
Last Updated
July 27, 2007
Sponsor
Sundsvall Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00508053
Brief Title
When Closing Midline Incisions, do Small Stitches Reduce the Risk for Incisional Hernia, Wound Infection or Dehiscence?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sundsvall Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Infection, Incisional Hernia, Wound Dehiscence
Keywords
wound infection, incisional hernia, wound dehiscence, wound healing, postoperative complications, surgical techniques

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
737 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Mass closure
Arm Title
2
Arm Type
Experimental
Arm Description
Small stitches
Intervention Type
Procedure
Intervention Name(s)
Small stitches
Intervention Type
Procedure
Intervention Name(s)
Mass closure
Primary Outcome Measure Information:
Title
Frequency of wound infection
Time Frame
Within the first 30 days after surgery
Title
Frequency of incisional hernia
Time Frame
One year after surgery
Secondary Outcome Measure Information:
Title
Frequency of wound dehiscence
Time Frame
Within the first 10 days after surgery
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Millbourn, MD
Organizational Affiliation
Sundsvall Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sundsvall Hospital
City
851 86 Sundsvall
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
19917943
Citation
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.
Results Reference
derived

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

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