Clinical trial NCT00508053: When Closing Midline Incisions, do Small Stitches Reduce the Risk for Incisional Hernia, Wound Infection or Dehiscence?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Infection
Incisional Hernia
Wound Dehiscence
Keywords: wound infection
incisional hernia
wound dehiscence
wound healing
postoperative complications
surgical techniques
Lead sponsor: Sundsvall Hospital
Sponsor class: OTHER
First posted: 2007-07-27
Enrollment: 737
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Frequency of wound infection
timeFrame: Within the first 30 days after surgery
measure: Frequency of incisional hernia
timeFrame: One year after surgery
Secondary outcomes:
measure: Frequency of wound dehiscence
timeFrame: Within the first 10 days after surgery
measure: 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..
timeFrame: Within 1 year.
Other outcomes:
Locations:
city: 851 86 Sundsvall
country: Sweden
facility: Sundsvall Hospital
Study officials:
affiliation: Sundsvall Hospital
name: Daniel Millbourn, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.