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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00508053
Enrollment
737
Registered
2007-07-27
Start date
2001-01-31
Completion date
2007-07-31
Last updated
2007-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incisional Hernia, Wound Dehiscence, Wound Infection

Keywords

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

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.

Interventions

PROCEDURESmall stitches
PROCEDUREMass closure

Sponsors

Sundsvall Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* Age under 18 * Previous surgery through a midline incision * Scars from previous surgery crossing the midline * Preexisting hernia in the midline (umbilical, epigastric)

Design outcomes

Primary

MeasureTime frame
Frequency of wound infectionWithin the first 30 days after surgery
Frequency of incisional herniaOne year after surgery

Secondary

MeasureTime frame
Frequency of wound dehiscenceWithin the first 10 days after surgery
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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026