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

This study has been completed.
Sponsor:
Information provided by:
Sundsvall Hospital
ClinicalTrials.gov Identifier:
NCT00508053
First received: July 25, 2007
Last updated: July 27, 2007
Last verified: July 2007
  Purpose

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.


Condition Intervention
Wound Infection
Incisional Hernia
Wound Dehiscence
Procedure: Small stitches
Procedure: Mass closure

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

Resource links provided by NLM:


Further study details as provided by Sundsvall Hospital:

Primary Outcome Measures:
  • Frequency of wound infection [ Time Frame: Within the first 30 days after surgery ]
  • Frequency of incisional hernia [ Time Frame: One year after surgery ]

Secondary Outcome Measures:
  • Frequency of wound dehiscence [ Time Frame: Within 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.. [ Time Frame: Within 1 year. ]

Enrollment: 737
Study Start Date: January 2001
Study Completion Date: July 2007
Arms Assigned Interventions
Active Comparator: 1
Mass closure
Procedure: Mass closure
Experimental: 2
Small stitches
Procedure: Small stitches

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00508053

Locations
Sweden
Sundsvall Hospital
851 86 Sundsvall, Sweden
Sponsors and Collaborators
Sundsvall Hospital
Investigators
Principal Investigator: Daniel Millbourn, MD Sundsvall Hospital
  More Information

No publications provided by Sundsvall Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00508053     History of Changes
Other Study ID Numbers: 2-Millbourn
Study First Received: July 25, 2007
Last Updated: July 27, 2007
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Sundsvall Hospital:
wound infection
incisional hernia
wound dehiscence
wound healing
postoperative complications
surgical techniques

Additional relevant MeSH terms:
Infection
Communicable Diseases
Hernia
Wound Infection
Pathological Conditions, Anatomical
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014