Femoral artery access wound study
ISRCTN | ISRCTN65306702 |
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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
Scientific
c/o Department of Surgery
Westmead Hospital
Westmead
Sydney
2145
Australia
Study information
Study design | Randomised controlled study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | Femoral artery access wound study |
Study objectives | 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(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) studied | 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 |
Primary outcome measure | 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 study start date | 01/03/1999 |
Completion date | 31/12/2000 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 100 incisions |
Key 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 |
Key exclusion criteria | 1. Redo vascular surgery to the femoral artery 2. Operating surgeon preference to withhold from trial |
Date of first enrolment | 01/05/1999 |
Date of final enrolment | 31/12/2000 |
Locations
Countries of recruitment
- Australia
Study participating centre
Westmead Hospital
Sydney
2145
Australia
2145
Australia
Sponsor information
Westmead Hospital (Australia) - Department of Surgery
Hospital/treatment centre
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 |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |