Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Femoral artery access wound study
Acronym
Study hypothesis
Open access to the femoral vessels is traditionally through a vertical incision. Although this approach gives good surgical access, wound healing can be complicated by sepsis, lymphatic leaks and wound breakdown.
Some causes for wound infections in vascular surgery are well known including emergency surgery, diabetes, having a groin incision and whether an autogenous or prosthetic graft is used. The effect of the type of groin incisions (vertical or transverse/oblique) on wound complications has been debated. There are a limited number of studies, which have looked at actual wound incision in terms of wound infection and lymphatic problems. These studies have been limited by either a short follow up or being a retrospective case analysis. These studies also did not assess the adequacy of the surgical access between the different incisions. We therefore conducted a prospective randomised study to look at the above problems.
Hypothesis:
The horizontal groin incision for femoral artery access has fewer wound complications than the vertical groin incision.
Ethics approval
Verbal ethics approval received from:
1. South Western Sydney Area Health Service Ethics Committee (Liverpool Hospital), February 2000, ref: 2000/022
2. Western Sydney Area Human Research Ethics Committee (Westmead Hospital), March 1999, ref: HREC2000/9/4.19(1090)
Formal ethics approval documents received from:
1. Westmead Hospital Ethics Committee (Australia), 12/09/2000
2. Liverpool Hospital Ethics Committee (Australia), 16/04/2000
This arrangement was due to the infrequent meetings of the ethics committees.
Study design
Randomised controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Femoral artery access
Intervention
Treatment arms were:
1. Patients with a vertical femoral access incision, or
2. Patients with a horizontal femoral access incision
Duration of treatment was the operation duration. Total follow up was 28 days.
The surgical technique used for the transverse incision was as follows: an incision above the groin skin crease when the main vessel to be accessed was the common femoral artery whilst it was placed below the groin skin crease when the main vessels to be accessed were the profunda femoris or superficial femoral arteries. The deep dissection was the same as that used for vertical incisions.
Please note that recruitment for the two centres were as follows:
1. Westmead Hospital started recruiting in May 1999 following verbal approval from the Westmead Hospital Ethics Committee, and finished recruiting in December 2000
2. Liverpool Hospital started recruiting in February 2000 following verbal approval from the Liverpool Hospital Ethics Committee, and finished recruiting in December 2000
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Uncomplicated healing
Secondary outcome measures
1. Wound infection
2, Lymphatic leak
3. Wound dehiscence
Wounds were examined at 4 days, 10 days and 28 days.
Overall trial start date
01/03/1999
Overall trial end date
31/12/2000
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients over the age of 18 and who could give informed consent
2. Consecutive patients undergoing vascular surgery involving femoral artery access
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100 incisions
Participant exclusion criteria
1. Redo vascular surgery to the femoral artery
2. Operating surgeon preference to withhold from trial
Recruitment start date
01/05/1999
Recruitment end date
31/12/2000
Locations
Countries of recruitment
Australia
Trial participating centre
Westmead Hospital
Sydney
2145
Australia
Sponsor information
Organisation
Westmead Hospital (Australia) - Department of Surgery
Sponsor details
c/o Professor John Fletcher
Westmead
New South Wales
2145
Australia
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Westmead Hospital and Liverpool Hospital (Australia) - Department of Surgery
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary