Wound surgical device found ineffective at infection control: ROSSINI Trial

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1. There was no significant effect in using a wound protection device to prevent surgical site infection.

2. Researchers found no significant difference in quality of life or hospital length of stay between device and control groups.

 Evidence Rating Level: 1 (Excellent)

Study Rundown: Data shows that 30-40% of abdominal surgery patients suffer from a surgical site infection (SSI) often increasing length of stay in the hospital and medical expenses associated with the event. This study, involving 21 UK hospitals, investigates the efficacy of wound edge protection devices in lowering the rate of SSI. A population of 735 were randomly assigned to a device group (n=382) or control group (n=378) to compare effectiveness.

In total, 184 patients experienced surgical site infection within 30 days of surgery, 91 in device group (24.7%) and 93 in control group (25.4%). This result was not significant (p=0.85) and researchers concluded that, contrary to earlier research, these wound protection devices are not clinically effective at preventing bacterial infection. This study is large in scale across various hospitals controlling for any bias associated with site or surgeon specific technique in the operation, however the study only examined the use of one device (the single ring variant) and fails to report on the different hospital locations where surgeries were performed to identify potential outliers.

Click to read the study in BMJ

Relevant Reading: A wound protector shields incision sites from bacterial invasion

In-Depth [randomized study]: This study is part of the ROSSINI trial (Reduction Of Surgical Site Infection using a Novel Intervention). Researchers used surgical site infection within 30 days as the primary outcome as well as quality of life and duration of hospital stay as secondary outcomes. All laparoscopic surgeries were excluded from the study and assessment of infection post-operation was randomized as well. Researchers identified no significant difference in quality of life between groups (mean difference in EQ-5D score .001, 95% confidence interval -.045 to .046 p=0.95) and length of stay was also not significant between groups (hazard ratio 1.03, 95% confidence interval 0.88 to 1.19; p=0.82).

By Jordan Anderson and Andrew Bishara

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