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It is accepted that the source of most surgical site infection (SSI) in clean elective cases is the patients’ skin microbial flora (1). Surgical site infection leads to longer hospital stay, antibiotic usage, repeat surgery, and if orthopaedic implants are infected, amputation or death. Prevention methods include laminar flow systems, scrub suits (2), extraction systems (3) and skin disinfection (4).
Surprisingly, no more than 80% of the initial bacterial load (5) is killed due to the application method; a non-scrubbed member of staff lifts and holds the limb whilst the antiseptic is ‘painted’ on using a sponge or gauze square in a sponge-holding forceps. This presents the potential for back and shoulder injury. If a tourniquet is used, a guard is required to prevent seepage of alcohol-containing antiseptic (6), (7). The antiseptic fails to reach bacteria within hair follicles, although repeated applications are thought to have a cumulative action (8).
The Limb Sheath is an innovative antiseptic application system. It is a sealed system which includes a tourniquet guard and a standard portal to instil antiseptic. As it is applied before induction of anaesthesia, the patient can lift their limb, thereby minimising the need for staff to lift the limb. It is applied sock-like to the distal edge of the tourniquet and 50ml of antiseptic instilled; the limb remains in contact with the antiseptic until it sleeve is removed in theatre. Drapes can be applied as the sleeve is retracted to a position level with the tourniquet.
Here we talk to the designer, Chris Bainbridge, who outlines why he and the team developed this innovative device.
What are the potential risk factors for SSI in the operating theatre?
Surgical site infection is a devastating complication of surgery. Since the time of Lister and his carbolic spray, surgeons have been able to undertake complex surgical procedures as a result of the prevention of surgical site infection. However the continuing toll of infected prostheses, infected vascular grafts, et cetera, secondary to contamination of the wound site with skin flora is testimony to how far we still have to go.
The safety of surgery can lead operating theatre personnel into a state of complacency where standards can slip. Even in the best units, pressure to maximise theatre throughput means that often the skin incision is made before the skin preparation has even had time to dry. We know that skin disinfectants need at least 10 minutes to reach their optimum function and even then a number of deeply placed skin bacteria will still survive. Lord Charnley in his groundbreaking work invented the concept of double prepping where the skin was trapped in the anaesthetic room, wrapped in a sterile drape and then the patient is transported into the theatre where the skin was re-prepped. Whilst reducing significant improvement in skin stability this technique is difficult to implement.
Is lifting a ‘dead’ limb an issue for theatre staff?
Lifting an anaesthetised limb is a major problem for many theatre staff. With the increasing obesity epidemic limbs are getting heavier and more ungainly. Whilst there are techniques to keep the leg locked at the knee they almost all contravene health and safety lifting criteria and in the United States have almost completely been outlawed.
As a result of some of the risks outlined above, you decided to find a solution. Was the Limb Sheath a light-bulb moment or the result of a consideration of various options?
I think the limb sheath was a result of a number of factors. Firstly I would tend to be an inveterate innovator in terms of surgery and surgical techniques, so extending this to skin preparation was quite normal for me.
At the time that we invented the Limb Sheath I was doing a large amount of lower limb trauma soft tissue reconstruction surgery and I think it helps to be slightly outside a field to be able to look on an area with fresh eyes. I was always aware when I visited the orthopaedic theatres of how much of a problem lifting the leg was and how the right size of person to lift the leg had to be chosen so that they were strong enough, and then that there had to be swapping over between the surgical team and the unscrubbed person holding the leg so that the preparation of the foot could be completed. This was a point at which contamination could occur. Then whilst assisting a surgeon who used a double prep technique, I suddenly thought ‘why was the leg not brought in a sterile fashion?’
I then went back to my own theatre and whilst carrying out a wrist arthroscopy suddenly realised that the concept of a cylindrical plastic tube with portals at each end would solve all the problems.
What are the major benefits of the Limb Sheath in terms of risk reduction and time/resource savings?
The aims of the limb sheath are to:
- Ensure that only the surgeon has to lift the limb so that we reduce and remove any possibility of lifting injury
- Reduce the risk of SSI to a minimum
- To provide total contact of the antiseptic medium in a liquid state to the surface of the skin for a period that was long enough that penetration into the hair follicles and sweat glands could occur and produce a step change reduction in the bacterial load
- Allow the limb preparation to occur in the anaesthetic room where there is often a period of waiting whilst the preparation of the operating theatre is completed. Utilising this time to allow limb preparation maximises the useful time in theatre.
I believe the limb sheath will remove any risk of lifting injuries in theatre, producing major reduction in skin bacterial load prior to surgery and help optimise and maximise theatre capacity.
Do you have any data as yet?
As part of our evaluation of the Limb Sheath system we carried out a single-blind no inferiority trial of the limb sheath versus standard limb preparation. We carried out this trial are in an operating theatre environment so were as close as possible to real use; the bacteriologist who calculated our bacterial load blinded to the type of skin preparation used.
Whilst we were hopeful of an improvement, we were mainly hoping for equality but were delighted to identify a major statistically significant fall in bacterial load (Box 1). More importantly, the Limb Sheath completely removed all pathogenic bacteria which were not completely removed by the standard technique.
Box 1: Summary of study results (8)
When clinical innovation and change are clinician-led, they are more likely to be adopted by other clinicians (9). The Limb Sheath system was designed to reduce theatre time, reduce lifting as far as possible, prolong antiseptic contact as long as possible and reduce wastage. The study results appear to support these aims.
If you would like to comment on any of the issues raised by this article, particularly from your own experience or insight, Healthcare-Arena would welcome your views.
- Altemeier WA, Culbertson WR, Hummel RP. Surgical considerations of endogenous infections- sources, types, and methods of control. Surgical Clinics of North America. 1968 48(1) 227–240
- Jacobson C, Osmon DR, Hanssen A, et al. Prevention of wound contamination using DuraPrep Solution plus Ioban 2 drapes Clinical Orthopaedics and Related Research. 2005 439 32-37
- Wong KC, Leung KS. Transmission and prevention of occupational infections in orthopaedic surgeons. Journal of Bone and Joint Surgery. 2004 86A(5) 1065-76
- Mackenzie I. Preoperative skin preparation and surgical outcome. Journal of Hospital Infection. 1988 11 (suppl B) 27-32
- Selwyn S, Ellis H. Skin Bacteria and Skin Disinfection Reconsidered. British Medical Journal. 1972 1(5793) 136-140
Ellanti P, Hurson C. Tourniquet-associated povidone-iodine-induced chemical burns BMJ Case Reports. 2015 Published online: [2015 Mar 5] doi:10.1136/bcr-2014-208967
- Dickinson JC, Bailey BN. Chemical burns beneath tourniquets British Medical Journal 1998. 297(6662) 1513
- Hardin W, Nichols R. Handwashing and patient skin preparation.
In: Malangoni MA (ed) Critical Issues in Operating Room Management 1997 Philadelphia, Lippincott-Raven
- Webb J, Hilliam R, Bainbridge LC. A Novel Device for Pre-operative Skin Preparation. Journal of Perioperative Practice. May 2017 (In Press)
- National Institute for Clinical and Health Excellence. How to Change Practice. Available at: https://www.nice.org.uk/media/default/about/what-we-do/into-practice/support-for-service-improvement-and-audit/how-to-change-practice-barriers-to-change.pdf