Comparative Study of a Iodine + Cyanoacrylate vs. Iodine and Isopropyl Alcohol in Skin Preparation for Prevention of Surgical Site Infections in Oncologic Surgery

Background: Skin preparation is considered an effective procedure to reduce contamination in the surgical field and to reduce surgical site infections (SSI). Some controversies exist regarding the efficacy of different products. Cyanoacrylate as microbial sealant seems to be an alternative to reduce the rate of SSIs.

Objective: To compare the frequency of SSI in a group of patients in which iodine + isopropyl alcohol was used (control group) vs. iodine + cyanoacrylate (experimental group) for the skin preparation in cancer surgical patients.

Methods: A randomized open clinical trial was conducted. Breast, digestive and gynecologic cancer patients undergoing elective surgery between March and July 2009 were included. Stratified randomization according to the type of neoplasia was done.  Patients were evaluated daily while in hospital, and each 7-10 days after discharge, for at least 30 days. Socio-demographic variables, associated comorbidities, previous oncologic treatment and surgery related variables were included. Intention to treat and per protocol analysis were done. Costs related to skin preparation, follow-up and complications were calculated.

Results: Two-hundred and sixty patients were included, 242 were women (93%). The average age was 52.6±12.6 years; 26 (48.4%) had breast cancer, 62 (23.8%) digestive tract cancer and 67 (25.7%) had a gynecological neoplasia. 130 patients were allocated to the experimental group, and 130 to the control group. Baseline characteristics of patients were similar between groups, except for the perioperative antibiotic prophylaxis, which was appropriate in 61.7% in the cyanoacrylate group compared to 46.7% in the control group (p< 0.05).  38 (14.6%) were diabetic, 89 (34.2%) had hypertension, and 73 (28.1%) had obesity. 22 SSI were diagnosed: 10 in the control group (5.5% in mastectomies, 1.6% in digestive tube surgery and 3% in hysterectomies) and 12 in the experimental group (7.1% in mastectomies, 1.6% in digestive tube surgery and 3% in hysterectomies) with no statistical differences neither by intention to treat or per protocol analysis. There were no differences in costs between the groups, but in those who developed a SSI the healthcare cost was increased independently of the allocation group.

Conclusions: There were no differences in the rate of SSIs associated to the use of iodine + cyanoacrylate compared to iodine+ isopropyl alcohol. The cyanoacrylates + iodine were as effective and safe as the iodine + isopropyl alcohol. To our knowledge, this is the first study on patients with cancer, and the first including clean and clean-contaminated surgeries using the cyanoacrylates.