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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00508053
Other study ID # 2-Millbourn
Secondary ID
Status Completed
Phase N/A
First received July 25, 2007
Last updated July 27, 2007
Start date January 2001
Est. completion date July 2007

Study information

Verified date July 2007
Source Sundsvall Hospital
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 737
Est. completion date July 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Intervention

Procedure:
Small stitches

Mass closure


Locations

Country Name City State
Sweden Sundsvall Hospital 851 86 Sundsvall

Sponsors (1)

Lead Sponsor Collaborator
Sundsvall Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of wound infection Within the first 30 days after surgery
Primary Frequency of incisional hernia One year after surgery
Secondary Frequency of wound dehiscence Within the first 10 days after surgery
Secondary 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.
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