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EXPERTS are debating the results of an Australian study, which has found that clean, non-sterile gloves are not inferior to sterile gloves in preventing wound infection after minor skin excision.
In a randomised controlled trial, researchers in Queensland compared the incidence of infection in 478 patients who received minor skin surgery at a primary care practice using either sterile or non-sterile gloves. (1)
The authors found that infection occurred in 9% of excisions, and that the rate of infection in the non-sterile group was not significantly different to that in the sterile gloves group.
They were able to perform the non-inferiority study because of known relatively high wound infection rates among patients in the practice, situated in a provincial town in Tropical North Queensland.
“The results of our study suggest that the use of non-sterile clean boxed gloves was not inferior to that of sterile gloves in relation to the incidence of infection.”
The authors said that previous evidence had shown sterile gloves were superior for more reconstructive procedures, such as skin flaps, and therefore did not recommend their findings be applied to more complicated procedures.
“However, the findings could be extrapolated to less complicated procedures in primary care, such as contraceptive implant insertion and minor procedures involving class 2 wounds such as suturing of lacerations”, the authors wrote.
The use of non-sterile versus sterile gloves also presented cost benefits, with about $1 saved per pair of gloves used.
“The cost saving benefit of using non-sterile gloves — without increasing infection rates — may be of particular relevance to developing countries with limited health care resources”, the authors said.
Dr Nicholas Demediuk, author of the Royal Australian College of General Practitioners (RACGP) infection prevention and control standards, welcomed the research and believed it reiterated what studies from overseas had found.
He told MJA InSight the results were in line with the RACGP’s existing guidelines, which recommended that sterile gloves be used only for sterile procedures. (2)
For minor procedures such as wound dressing, suturing and removal of minor skin lesions, RACGP advised that clean, single-use gloves were appropriate to use.
Dr Demediuk said there was a key message in the research that could benefit many Australian GPs who still used sterile gloves for minor procedures.
“If more GPs were aware of these studies, which prove it’s OK to use clean and less expensive gloves, they would save money and improve the cost efficiency of their practices.”
However, Dr Ann Koehler, director of the Communicable Disease Control Branch at SA Health, believed the practices reported in the paper breached the National Health and Medical Research Council’s (NHMRC) Australian Guidelines for the Prevention and Control of Infection in Healthcare (2010). (3)
“[NHMRC] recommendations for surgical aseptic technique on surgical procedures, including use of sterile gloves, are stated to apply to all surgical procedures regardless of setting, including office-based practice.”
Dr Koehler believed the general practice featured in the study recorded an unacceptably high rate of wound infection, and that there was insufficient evidence provided to accept this was caused by Queensland’s tropical environment.
“It is puzzling that with an already huge infection rate compared to the accepted levels of 1%–3%, the practice in this study is prepared to introduce yet another risk for infection; the use of non-sterile gloves.”
She said there were additional advantages for GPs using sterile gloves not addressed in the research. “Sterile gloves are more comfortable, with better fit leading to increased dexterity, and are thicker, providing better protection for the health care worker should there be a needle stick injury.”
Dr Anthony Dixon, skin cancer specialist and director of education at the Australian College of Cutaneous Oncology, said that both GPs and researchers needed to look beyond just the issue of glove sterility to more basic practices such as ensuring adequate hand hygiene.
Dr Dixon said that although he welcomed Australian research on glove sterilisation, the study also raised other issues for consideration, such as the need for greater GP education on how to manage simple wound infections after minor skin excision.
1. MJA 2015; 202: 27-31
2. RACGP; Infection prevention and control standards, 5th ed
3. NHMRC; Australian Guidelines for the Prevention and Control of Infection in Healthcare 2010
(Photo: albicoccoalcuraro / iStock)
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Sterile gloves should be used for elective surgery-they are sterile.,
You elect to perform an excision on clean skin, therefore you have a duty of care to use clean gloves, not to use gloves from a box that your nurse used to clean a MRSA contaminated wounds or your cleaner used to clean the toliet.
You should not even be operating in a dirty room-one used for contaminated wounds, nor a room with dirty open box of gloves.
Sterile elective procedures shlould be done done in a room reserved for sterile procedures, with sterile equipment, including sterile gloves. The cost of using sterile gloves is less than the cost of opening a new box of non-sterile gloves for each patient. Any open box of gloves could be contaminated with anything, includind faeces if any person failed tp wash their hands after going to the toilet, then used the non-sterile box to access gloves to clean the toliet.
SIngle use means single use-not MRSA, not toliet use.
I am often disappointed when I see people concentrate solely on evidence from clinical trials and nothing else. Ideally, in my opinion, (a) clinical reasoning, (b) scientific reasoning, (c) common sense, and (d) evidence from clinical trials should all be considered in such a question, and only together they provide the complete picture.
Questions that arise, in my opinion, are:
(1) What exactly was the size of the minor surgeries that the non-sterile gloves were used in? At what size of surgery should one stop using non-sterile gloves and convert to sterile ones?
(2) Were the non-sterile gloves used to touch the surgical wound? If the gloves were only used to hold the ends of the surgical instruments, then it is biologically plausible that wound contamination would have to be minor. Also note that sterile gloves make clinical sense when there is a ‘sterile’ surgical field with sterile drapes surrounding the wound, otherwise they don’t.
(3) Non-sterile gloves are well known to contain very low (negligible) levels of germs (but not being technically ‘sterile’) when fresh out of the box. Meaning that the numerical risk or statistical chance of contamination is very low, and one may not see a statistical difference in infection rates in a study like this. But what if an individual box has been open for a prolonged period of time and there is accidental contamination? Unlikely to be picked up by a study such as this.
(4) Surgical infections are multifactorial, and one factor is the resistance of the host patient. Would one be comfortable to do the same with patients who have minor immunosuppression, such as corticosteroid treatment or renal dialysis, that may be seen in gerenal practice?
It is interesting to read the above comments and I wonder how many of them are influenced by the possibility of being sued should an infection occur following a procedure. Many years ago as a student back in the 1960’s I spent most of my Saturdays in the casualty departments of all the teaching hospitals suturing minor and some major trauma cases. This was long before the threat of HIV infections and I rarely wore gloves. Limited follow up did not disclose any increase in infection by not wearing gloves. Later on there was some controversy as to whether gloves should be worn when inserting intravenous lines. My own experience was again no increase in infection rates.
Perhaps adequate hand washing with betadine would limit infection and not increase the rate. As stated above, gloves are used primarily to protect the operator, although a clean pair of gloves should be employed in performing elective surgery. As to whether those gloves should be sterile or clean from a reusable box remains the perogative of the operator.
The paper by Heal and others comparing sterile to non sterile gloves for simple excisions is a non-inferiority trial but the authors chose an excessively large non-inferiority margin of 7%. They propose that with a background incidence of 8%, any incidence up to 15% would be regarded as clinicallly non-inferior. The non-inferiority margin, or Minimum Clinically Important Difference is further explained here: http://www.australianprescriber.com/magazine/36/5/170/3
This suggests that it is acceptable that for every 14 people treated with non sterile gloves there would be one more infection. The cost saving would be $14.70 in gloves, but each extra infection would cause an extra consultation and a course of antibiotics costing far inexcess of this. I dont think that patients, doctors or health funders would regard this as reasonable. The implication is that the trial was underpowered to detect a reasonable non-inferiority margin.
The high infection rate in both groups in this study from far north QLD doesnt convinve me that I should abandon sterile gloves for simple excisions where I work in Newcastle. My infection rate is unmeasured but I hope it is less than 9%, and I would worry that whatever drives the high infection rate in QLD was obscuring the difference between glove types.
If “no touch” technique is used the gloves should not matter, but there is no good alternative to grasping the suture needle in the fingers while tying knots.
1. To use $1 per procedure as a reason to risk infection, does seem a little mean. I’m sure if you asked the patient if they’d prefer to pay a dollar more to have a lower risk, they’d not hesitate to offer to pay it.
2. Dr. Koehler is correct when she states that 9% infection rate is unacceptable. Maybe the authors should focus their research attempts at finding ways to decrease this rate than on finding ways to save a miserable dollar per procedure.
A closed box of gloves may be surgically clean. Once opened hands are going in and out of the box, and debris and sprays are landing on the said open box. I would not consider an open box surgically clean for the purpose of a procedure. These gloves are purely for the protection of the wearer for simple examinations.
It is an arbitrary distinction between complicated and simple pocedures and it makes little if any sense to assign procedures for the purpose of which gloves to use.
In terms of medical defence I would think that the best defence against challenge in the event of a significant infection would be the use of best practice as advised by Dr. Koehler and the proper recording of exactly what was done.