ISRCTN ISRCTN65306702
DOI https://doi.org/10.1186/ISRCTN65306702
Secondary identifying numbers N/A
Submission date
05/11/2007
Registration date
16/11/2007
Last edited
15/05/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jan Swinnen
Scientific

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

Study information

Study designRandomised controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleFemoral artery access wound study
Study objectivesOpen 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(s)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.
Health condition(s) or problem(s) studiedFemoral artery access
InterventionTreatment 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 typeProcedure/Surgery
Primary outcome measureUncomplicated healing
Secondary outcome measures1. Wound infection
2, Lymphatic leak
3. Wound dehiscence

Wounds were examined at 4 days, 10 days and 28 days.
Overall study start date01/03/1999
Completion date31/12/2000

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants100 incisions
Key inclusion criteria1. Patients over the age of 18 and who could give informed consent
2. Consecutive patients undergoing vascular surgery involving femoral artery access
Key exclusion criteria1. Redo vascular surgery to the femoral artery
2. Operating surgeon preference to withhold from trial
Date of first enrolment01/05/1999
Date of final enrolment31/12/2000

Locations

Countries of recruitment

  • Australia

Study participating centre

Westmead Hospital
Sydney
2145
Australia

Sponsor information

Westmead Hospital (Australia) - Department of Surgery
Hospital/treatment centre

c/o Professor John Fletcher
Westmead
New South Wales
2145
Australia

Website http://www.swahs.health.nsw.gov.au/westmead/index.htm
ROR logo "ROR" https://ror.org/04gp5yv64

Funders

Funder type

Hospital/treatment centre

Westmead Hospital and Liverpool Hospital (Australia) - Department of Surgery

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan