Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Unspecified Infection (1930)
|
Event Date 01/01/2019 |
Event Type
Injury
|
Event Description
|
It was reported via journal article: title: a change in protocol of wound care in spinal surgery and its impact on post-operative wound infections in neurosurgery.The aim of our study is to determine if a closed dressing protocol reduces surgical site infections (ssi).A total of 372 patients primo-operated spine procedures from april 2016 to july 2017 were included.They were separated in 2 groups: closed-protocol (n=195), where we applied the dressing system dermabond prineo (a selfadhering mesh with 2-octyl-cyanoacrylate skin glue, enhanced with a transparent film (opsite) removed after 14 days; and conventional-protocol (n=177), which included dermal, intradermal sutures or staples.Surgical closure of fascia and subcutaneous layer was identical in both groups.In spite of the clear trend towards reduced ssi, data did not reach statistical significance (p=0.12).These patients were all re-operated and successfully treated with iv antibiotics.Reported postoperative complications in the closed-protocol group included n=3 infections.In conclusion, the introduction of a closed-protocol was followed by a decrease of ssi of 33% in our cohort.
|
|
Manufacturer Narrative
|
(b)(4).Additional information has been requested however not received to date.If further details are received at a later date a supplemental medwatch will be sent.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon products involved: dermabond prineo, caused and/or contributed to the post-operative complications: infections, described in the article? does the surgeon believe there was any deficiency with the ethicon products: dermabond prineo, used in these procedures? this report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: web address: child's nervous system 2020; conference: 27th congress of european society for pediatric neurosurgery.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
|
|
Search Alerts/Recalls
|
|