Clinical Evidence Summary

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)² 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.

Ioban is the only Class III antimicrobial incise drape that is clinically proven with published studies across multiple specialties^3-7, trusted by surgeons around the world to protect patients in millions of procedures.

Guidelines recommend that if an incise drape is required, an iodophor-impregnated drape should be used unless the patient has an iodine allergy.⁸

Explore the evidence in this easy to digest clinical summary.

References

1. Medical Device Regulation 745/2017
2. Medical Device Directive 93/42/EEC
3. 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
4. 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.
5. 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.
6. 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.
7. 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.
8. NICE (2019) Surgical site infections: prevention and treatment, Clinical guideline [NG125]. Published April 2019.