CClinicalTrials.gg
CompletedNCT00508053Updated Jul 30, 2007

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

An interventional study of Small stitches and Mass closure in Wound Infection, Incisional Hernia and Wound Dehiscence, sponsored by Sundsvall Hospital. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-07-30.

Sponsored by Sundsvall Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
737
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Wound Infection
  • Incisional Hernia
  • Wound Dehiscence

Keywords

  • wound infection
  • incisional hernia
  • wound dehiscence
  • wound healing
  • postoperative complications
  • surgical techniques
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 737 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Sundsvall Hospital is the lead sponsor of 22 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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)
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
737 participants (actual)

Study arms

  • Active comparator
    1

    Mass closure

    Procedure: Mass closure

  • Experimental
    2

    Small stitches

    Procedure: Small stitches

Interventions

  • ProcedureSmall stitches
  • ProcedureMass closure
06

What researchers measure

Primary outcomes

  1. Frequency of wound infection

    Time frame: Within the first 30 days after surgery

  2. Frequency of incisional hernia

    Time frame: One year after surgery

Secondary outcomes

  1. Frequency of wound dehiscence

    Time frame: Within the first 10 days after surgery

  2. 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.

07

Study locations

1 site
  • Sundsvall Hospital
    851 86 Sundsvall, Sweden
08

References and documents

Publications

  • 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. PubMed 19917943 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00508053
Lead sponsor
Sundsvall Hospital
First posted
Jul 27, 2007
Start date
Jan 2001
Completion
Jul 2007
Last update
Jul 30, 2007

Study contacts

Daniel Millbourn, MD
principal investigator · Sundsvall Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2007. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion