Reducing the risk of Surgical Site Infections
3M™ Ioban™ 2 Antimicrobial Incise Drapes offer several clinical benefits for you and your patients such as creating a barrier, reducing the risk of bacteria transferring into the surgical wound, providing continuous broad-spectrum antimicrobial activity all the way to the incision edge and adhering securely to the skin to help prevent drape lift and prep wash-off.
Impact of Surgical Site Infections
There is a vast array of evidence which demonstrates the negative effects of surgical site infections; from increased morbidity, cost of care and length of hospital stay, to decreased patient satisfaction scores and lower quality of life.
Evidence shows that nearly 5% of surgical patients will go on to develop an SSI1.
Since we know that the risk of acquiring an SSI is directly linked to the number of skin microbes on a patient’s skin, appropriate skin preparation before and throughout surgery is key.
The risk
The Centers for Disease Control and Prevention (CDC) state that the risk of surgical site infection (SSI) can be measured according to three distinct variables:
-
The resistance of the host i.e. how good the patient's immune system is.
-
The dose of microbial contamination i.e. how many microbes there are.
-
The virulence of contaminating microbes i.e. how infectious the microbes are.
Ioban reaches the parts of skin that skin preps don’t
Whilst skin preps reduce microbes on the skin surface, bacteria in the deeper skin layers will remain. Over time these microbes will recolonise the skin surface. If these microbes then contaminate the surgical wound; an SSI is likely to occur.
A study from Elliott et al (2015) now demonstrates that iodine released from 3M™ Ioban™ Antimicrobial Incise Drapes2 is able to penetrate the deeper skin layers at a concentration required for microbial death2.
Safe Sterilisation
Incise drapes are usually sterilised using either gamma irradiation or ethylene oxide. The method used can have an impact on the chemical composition of the iodine contained within the drape.
It is well-documented that when products containing iodine come into contact with ethylene oxide, ethylene iodohydrin can be produced. This can be a skin irritant and is why 3M sterilises Ioban Incise Drapes using gamma irradiation.
Clinical Evidence Summary: Bejko et al. Comparison of efficacy and cost of iodine impregnated drape vs. standard drape in cardiac surgery: Study in 5100 patients.
-
J Cardiovasc Trans. Res. 2015.3
Objective
Examine the efficacy in preventing SSI in cardiac surgery, using two different drapes; an iodine impregnated drape (Ioban drape) and a non-iodine impregnated drape (standard drape). The cost effectiveness of each drape was also evaluated.
-
Methodology
A total of 1616 patients undergoing cardiac surgery were matched in terms of risk factors. 808 patients received Ioban drapes, and the other group of 808 patients received a standard drape.
The overall costs of treating each patient group was then measured, taking into consideration the cost of drapes, antibiotic treatment, VAC therapy, sternal wound revision staff salaries and extended hospital stay.
Findings
SSI rates for the group which received the standard drape was measured to be 6.5%. In comparison the SSI rate for the group which received the Ioban drape was 1.9%; a statistically significant difference.
Results from the cost analysis demonstrated that the use of an Ioban drape offered a total cost saving of €773,495 - equivalent to €957 per patient.
-
Clinical Evidence Summary: Yoshimura et al. Plastic iodophor drape during liver surgery operative use of the iodophor impregnated adhesive drape to prevent wound infection during high risk surgery. World J. Surgery. 2003.4
Objective
To investigate the risk factors associated with surgical site infection in liver surgery, with special attention paid to the use of iodophor impregnated drapes (Ioban drapes).Methodology
A retrospective study on 296 patients undergoing liver surgery. A total of 122 patients received an Ioban drape, whilst 174 patients received no drape at all. The SSI rates across both groups was then compared.Findings
SSI rates in the patient group who were not treated with a drape was measured at 12.1%. In contrast, the SSI rate in the patient group who were treated with an Ioban drape was 3.1%; a statistically significant difference. The author concluded “the non-use of iodophor drapes is a possible risk factor for wound infection after liver surgery”.
Trusted for over 30 years
Ioban drapes have been used in millions of procedures worldwide for over 30 years. Its effectiveness has been documented in numerous clinical studies dating from the 1980’s until the present day. No other incise drape offers this level of assurance.
Clinical studies have shown that Ioban drapes are effective at reducing wound contamination, surgical site infections, and most recently, cost.
"NICE recommends: If an incise drape is required for surgery, use an iodophor-impregnated drape unless the patient has an iodine allergy."
-
Class III Medical Device
In accordance with the EU Medical Device Directive, Ioban drapes are classified as a Class III medical device. This is because the iodine in the incise drape is a drug which works in the deeper layers of a patient’s skin to reduce the risk of SSI.
To be awarded a class III status, the manufacturer must present evidence to prove both the device and drug component are safe and effective.
Class II incise drapes do not offer the same level of assurance. Their drug component has not been assessed for safety of efficacy as the manufacturer submitted evidence that the drug component does not act on the human body.
We're committed to improving surgical care and patient outcomes, that's why we fight SSIs from every angle.
Contact 3M
Discover how our education, information and tools can support you beyond the operating room, so you can depend on us the way your patients depend on you.
References
-
1. Smyth ET et al. (2008) Four Country Healthcare Associated Infection Prevalence Survey 2006: Overview of the results. Journal of Hospital Infection; 69:230–48.
2. Elliott et al. Antimicrobial activity and skin permeation of iodine present in an iodine-impregnated surgical incise drape. J. Antimicrobial Chemotherapy. 2015.
3. Bejko et al. Comparison of efficacy and cost of iodine impregnated drape vs. standard in cardiac surgery: study in 5100 patients. J Cardiovasc Trans. Res. 2015; 8:431-437.
4. Yoshimura et al. Plastic iodophor drape during liver surgery operative use of the iodophor impregnated adhesive drape to prevent wound infection during high risk surgery. World J. Surgery. 2003; 27:685-688.
