NCT00508053

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
737

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
6.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2007

Completed
Last Updated

July 30, 2007

Status Verified

July 1, 2007

First QC Date

July 25, 2007

Last Update Submit

July 27, 2007

Conditions

Wound InfectionIncisional HerniaWound Dehiscence

Keywords

wound infectionincisional herniawound dehiscencewound healingpostoperative complicationssurgical techniques

Outcome Measures

Primary Outcomes (2)

  • Frequency of wound infection

    Within the first 30 days after surgery

  • Frequency of incisional hernia

    One year after surgery

Secondary Outcomes (2)

  • Frequency of wound dehiscence

    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..

    Within 1 year.

Study Arms (2)

1

ACTIVE COMPARATOR

Mass closure

Procedure: Mass closure

2

EXPERIMENTAL

Small stitches

Procedure: Small stitches

Interventions

Small stitchesPROCEDURE
2
Mass closurePROCEDURE
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patient with an acute or planned operation trough a midline incision at the Surgical Department in Sundsvall, Sweden

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sundsvall Hospital

851 86 Sundsvall, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 19917943DERIVED

MeSH Terms

Conditions

Wound InfectionIncisional HerniaPostoperative Complications

Condition Hierarchy (Ancestors)

InfectionsHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Daniel Millbourn, MD

    Sundsvall Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 25, 2007

First Posted

July 27, 2007

Study Start

January 1, 2001

Study Completion

July 1, 2007

Last Updated

July 30, 2007

Record last verified: 2007-07

Locations

SE(1)