Condition category
Surgery
Date applied
05/11/2007
Date assigned
16/11/2007
Last edited
15/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jan Swinnen

ORCID ID

Contact details

c/o Department of Surgery
Westmead Hospital
Westmead
Sydney
2145
Australia

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

http://www.swahs.health.nsw.gov.au/westmead/index.htm

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

Publication citations

Additional files

Editorial Notes