A surgeon makes an incision on a patient with Ioban incuse drape applied to skin

3M™ Ioban 2™ Antimicrobial Incise Drapes

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A trusted choice to reduce the risk of surgical site infection (SSI)

More than just an adhesive drape, Ioban antimicrobial incise drapes are designed to help reduce the risk of SSIs. They are applied to a patient's skin at the site of a surgical incision to create a sterile surface and deliver broad – spectrum antimicrobial activity throughout the surgical procedure.

Not all incise drapes are equal

To market a Class III medical device under the Medical Device Regulation (MDR)¹ or Medical Device Directive (MDD)⁹ the manufacturer must present evidence to prove both the medical device and drug component are safe and effective. 3M meets these criteria, and continuously updates technical and clinical evidence to substantiate the effectiveness of Ioban drapes and secure Class III status.

Ioban is the only Class III antimicrobial incise drape that is clinically proven with published studies across multiple specialties^2-6, trusted by surgeons around the world to protect patients in millions of procedures.

Guidelines recommending the use of an iodophor-impregnated drape^7,8 are grounded on studies specifically comparing the effectiveness of Ioban antimicrobial incise drapes in the reduction of surgical site infections (SSIs) versus clear incise drapes⁵ or surgical preps alone.⁶

Reduction in Surgical Site Infection

A prospective randomised study reported an SSI rate of 1.9% in patients which received Ioban drapes compared with 6.5% SSI rate for patients which received standard drapes.⁵
Cost Savings Per Patient

A cost analysis demonstrated that although the upfront cost of an Ioban incise drape was greater than a standard incise drape, once the additional costs associated with SSI were accounted for, the use of the Ioban incise drapes offered cost savings of up to €957 per patient.⁵
Supported by Clinical Evidence

Ioban drapes have been used in millions of procedures. Its eﬀectiveness has been documented in numerous clinical studies over the last 30 years. 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 cost.

Helping to protect patients from surgical site infections across the incision pathway

Explore the Clinical Evidence

Ioban’s effectiveness in helping to reduce the risk of surgical site infections is supported by published clinical evidence in multiple surgical specialities.^2-6

Explore the evidence in this easy to digest clinical summary.

Request EVIDENCE SUMMARY
Incision Management: from preparation to post-op healing

Discover how to position incision management in the patient care pathway, define Surgical Site Complications and the difference compared to Surgical Site Infection.

Understand the most important reasons for using an antimicrobial incise drape, along with evidence and guidelines, and explore the purpose and advantages of Closed Incision Negative Pressure Wound Therapy (CiNPWT).

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A trusted, proven solution to help keep your patients safe

Why does classification of a medical device matter?

Ioban Antimicrobial Incise Drapes are classified as Class III medical devices. This is because the iodine incorporated into the incise drape is a drug which works in the deeper layers of a patient’s skin¹ to reduce the risk of surgical site infections (SSI).^5,6

In accordance with the Medical Device Regulation¹ (Rule 14, MDR 745/2017) and the European Medical Device Directive⁹ (Rule 13, Annex IX, MDD 93/42/EEC), all devices containing a drug component (as defined in 2001/83/EC) which is liable to act on the human body with action ancillary to that of the device, are in Class III.

Ioban is the only Class III antimicrobial incise drape that has published clinical evidence across multiple specialites to support its use,^2-6 trusted by surgeons around the world to protect patients in millions of procedures.

Class lla and llb incise drapes have another intended use in comparison with Class III medical devices. These products are not classified as incorporating an active drug component that can penetrate the patient’s skin.

Open Medical Device Directive (PDF, 349 KB)
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.

3M is focused on proven solutions that protect you and your patients, so you can focus on what matters most

3M is here to help with science-centred solutions and clinical evidence-based therapies to improve efficiency, prevent complications and deliver better patient outcomes. Every patient. Every time.

Find out more about how 3M can support you in the prevention of surgical site complications from patient preparation, to surgical intervention, and enhanced recovery.

VISIT 3M OPERATING ROOM SOLUTIONS WEBSITE

Sources of vascular-associated bloodstream infections diagram

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NOTE: Specific indications, contraindications, warnings, precautions and safety information exist for these products and therapies. Please consult a clinician and product instructions for use prior to application. This material is intended for healthcare professionals.

References

1. Medical Device Regulation 745/2017
2. Karapinar K, Kocatürk CI. The Effectiveness of Sterile Wound Drapes in the Prevention of Surgical Site Infection in Thoracic Surgery. BioMed Research International. 2019, doi.org/10.1155/2019/143879
3. Rezapoor M, T, Maltenfort M et al. Incise Draping Reduces the Rate of Contamination of the Surgical Site During Hip Surgery: A Prospective, Randomized Trial. The Journal of Arthroplasty (2018), doi: 10.1016/j.arth.2018.01.013.
4. Hesselvig AB, Arpi M, Madsen F et al. Does an Antimicrobial Incision Drape Prevent Intraoperative Contamination? A Randomized Controlled Trial of 1187 Patients. Clin Orthop Relat Res (2020) 478:1007-1015. DOI 10.1097/CORR.0000000000001142.
5. Bejko J, Tarsia V, Carrozzini M, et al. Comparison of efficacy and cost of iodine impregnated drape vs. standard drape in cardiac surgery: study in 5100 patients. J Cardiovasc Transl Res.2015;8:431-7.
6. Yoshimura Y, Kubo S, Hirohashi K 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. Surg.2003;27:6.
7. NICE (2019) Surgical site infections: prevention and treatment, Clinical guideline [NG125]. Published April 2019.
8. RKI (2018) Prevention of postoperative wound infections: Commission recommendation for hospital hygiene and infection prevention (KRINKO)
9. Medical Device Directive 93/42 (EEC)
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