BIOGLUE SURGICAL ADHESIVE
Report
- Report Number
- 1063481-2010-00039
- Event Type
- Injury
- Date Received
- November 11, 2010
- Report Date
- April 26, 2011
- Manufacturer
- CRYOLIFE, INC.
- Product Code
- MUQ
- PMA / PMN Number
- P010003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
ACCORDING TO THE PUBLICATION, "SURGICAL SITE INFECTION ASSOCIATED WITH THE USE OF BOVINE SERUM ALBUMIN-GLUTARALDEHYDE SURGICAL ADHESIVE (BIOGLUE) IN CRANIAL SURGERY: A CASE CONTROL STUDY", BIOGLUE WAS USED IN SEVERAL CRANIAL PROCEDURES TO OBTAIN A WATERTIGHT CLOSURE OF THE DURA MATTER. THE STUDY SUGGESTS THAT BIOGLUE CAN BE AN INDEPENDENT RISK FACTOR OF SSI ACCORDING TO CSF LEAKAGE OR SOME SPECIFIC KIND OF SURGERY. A REVIEW OF THE PUBLICATION INDICATES THAT THE STUDY PRESENTS CIRCUMSTANTIAL DATA THAT SUGGESTS A POTENTIAL LINK BETWEEN BIOGLUE AND SURGICAL SITE INFECTIONS FOLLOWING NEUROSURGICAL PROCEDURES. HOWEVER, THE DATA IS NOT CONCLUSIVE. THERE ARE ISSUES RELATING TO THE DESIGN OF THE STUDY THAT SHOULD BE CONSIDERED WHEN DETERMINING THE SIGNIFICANCE OF THE RESULTS. SIXTY CONTROLS WERE RANDOMLY SELECTED AND WERE NOT MATCHED TO THE STUDY POPULATION. THE MEAN LENGTH OF SURGERY IN THE STUDY GROUP WAS 311 MINUTES AS COMPARED TO 186 MINUTES IN THE CONTROL GROUP. THE LENGTH OF THE SURGERY WOULD BE AN OBVIOUS CONFOUNDING FACTOR THAT COULD SKEW THE RESULTS. IN ADDITION, THE INCREASED MEAN SURGERY LENGTH WOULD ALSO IMPLY THAT MORE COMPLEX PROCEDURES WERE BEING PERFORMED IN THE STUDY GROUP. CRYOLIFE WAS ALSO INFORMED THAT A MAJORITY OF THE SSIS THAT WERE OBSERVED OCCURRED WITH A SINGLE SURGEON. THAT PARTICULAR SURGEON ALSO COATED THE ENTIRE SURFACE OF THE NEURO-PATCH THEREBY INTERFERING WITH ITS INTENDED FUNCTION BY PREVENTING IMMIGRATION OF CONNECTIVE TISSUE CELLS. OTHER CO-MORBIDITIES THAT MAY HAVE INCREASED THE RISK OF INFECTION IN THE STUDY POPULATION SUCH AS DIABETES, CANCER, OR IMMUNOCOMPROMISED STATES WERE NOT ADDRESSED. BIOGLUE IS TERMINALLY STERILIZED BY GAMMA IRRADIATION; THE RISK OF INTRODUCTION OF BACTERIA INTO THE SURGICAL SITE BY THE PRODUCT ITSELF IS EXCEEDINGLY UNLIKELY. ALTHOUGH AN INFLAMMATORY REACTION TO BIOGLUE OR OTHER IMPLANT MATERIAL MAY INCREASE THE RISK OF SSI, THERE IS NOTHING TO SUGGEST A DIRECT RELATIONSHIP BETWEEN THE USE OF BIOGLUE AND THE REPORTED EVENTS. WHEN BIOGLUE IS USED IN CONJUNCTION WITH ANY OTHER MATERIAL THE INSTRUCTIONS FOR USE (IFU) FOR ALL PRODUCTS SHOULD BE CAREFULLY REVIEWED AND ADHERED TO. IT IS UNKNOWN WHETHER THE FAILURE TO USE OF NEURO-PATCH IN ACCORDANCE WITH ITS IFU CONTRIBUTED TO THESE EVENTS. THE USE OF BIOGLUE IN THIS APPLICATION IS NOT AN APPROVED INDICATION FOR USE IN THE US.
AN INVESTIGATION HAS BEEN INITIATED AND ANY ADDITIONAL INFORMATION WILL BE SUBMITTED IN A FOLLOW-UP REPORT.
ACCORDING TO THE PUBLICATION, SURGICAL SITE INFECTION ASSOCIATED WITH THE USE OF BOVINE SERUM ALBUMIN-GLUTARALDEHYDE SURGICAL ADHESIVE (BIOGLUE) IN CRANIAL SURGERY: A CASE CONTROL STUDY, BIOGLUE WAS USED IN SEVERAL CRANIAL PROCEDURES TO OBTAIN A WATER-TIGHT CLOSURE OF THE DURA MATER. IF THE DURAL DEFECT WAS VERY SMALL, BIOGLUE ALONE WAS APPLIED ON A PATCH OF SURGICEL (JOHNSON AND JOHNSON MEDICAL), IF THE DEFECT WAS LARGER DURAPLASTY WAS USED WITH SUTURE EITHER ALONE OR WITH BIOGLUE. SURGEONS USED UPPERMOST AUTOGRAFT, BUT IF NOT AVAILABLE IN THE DESIRED QUANTITY AND SHAPE NEUROPATCH (AESCULAP, INC.) WAS USED. A CASE-CONTROL STUDY OF PATIENTS WHO UNDERWENT CRANIOTOMY IN THE DEPARTMENT OF NEUROSURGERY AT (B)(6) HOSPITAL WAS CARRIED OUT FROM (B)(6) 2006 TO (B)(6) 2007. SUPRA- OR INFRATENTORIAL CRANIOTOMY PROCEDURES ARE INCLUDED IN THIS CASE STUDY WHILE BURR HOLE OPERATIONS AND SHUNT PROCEDURES ARE EXCLUDED. THE DATA WAS RETROSPECTIVELY REVIEWED BY TWO INDEPENDENT INVESTIGATORS. THERE ARE TWO CONTROLS PER EACH CASE, CONTROLS WERE NOT MATCHED AND WERE RANDOMLY DETERMINED BASED ON POSTOPERATIVE REPORTS. THE CASE GROUP CONSISTED OF 30 PATIENTS WHO DEVELOPED A SURGICAL SITE INFECTION (SSI) AND THE CONTROL GROUP CONSISTED OF 60 PATIENTS WHO DID NOT DEVELOP AN SSI. BIOGLUE WAS USED IN 13 PATIENTS IN THE CASE GROUP (43.3%), 12 OF THESE 13 PATIENTS ALSO RECEIVED NEUROPATCH. FOUR OF THE PATIENTS IN THE CONTROL GROUP RECEIVED BIOGLUE (6.7%), TWO OF THESE FOUR PATIENTS ALSO RECEIVED NEUROPATCH. THE CASE REPORT CONCLUDED THAT BIOGLUE AS A DURAL SEALANT HAS A STRONG STATISTICAL ASSOCIATION WITH THE OCCURRENCE OF SSI IN CRANIOTOMY (P=0.007). TWO OTHER RISK FACTORS WERE ALSO DETERMINED: SURGERY LENGTH AND AVERAGE YOUNGER AGE. HOWEVER, THE CASE REPORT ALSO WARNS AGAINST A POSSIBLE BIAS IN THEIR RESULTS. CONTROLS WERE NOT MATCHED ACCORDING TO KNOWN RISK FACTORS OF SSI, BIOGLUE USE COULD BE A CONFOUND BIAS SINCE THE TYPES OF SURGERY MOST ASSOCIATED WITH SSI AND THE ONES THAT MOST OFTEN REQUIRE DURAPLASTY, AND CSF LEAKAGE WAS NOT INCLUDED IN THEIR ANALYSIS DUE TO LACK OF DATA. THE STUDY SUGGESTS THAT BIOGLUE CAN BE AN INDEPENDENT RISK FACTOR OF SSI ACCORDING TO CSF LEAKAGE OR SOME SPECIFIC KIND OF SURGERY (E.G. CRANIAL BASE SURGERY). (B)(6) HOSPITAL NOTICED A SUBSTANTIAL INCREASE OF SSI INCIDENCE (5.4% VS 1%) IN THEIR UNIT WHEN BIOGLUE WAS USED AND A RETURN TO NORMAL RATES WHEN USE OF BIOGLUE WAS STOPPED. THEY ALSO STATED THAT NO CHANGES OTHER THAN NOT USING BIOGLUE WERE MADE. GABEREL AT EL., STATES THE RESULTS OF THEIR INVESTIGATION SHOW THAT BIOGLUE RAISES THE RISK OF SSI IN PATIENTS UNDERGOING CRANIOTOMY, PROBABLY BECAUSE IT TRIGGERS BOTH INTENSE ACUTE AND CHRONIC INFLAMMATORY RESPONSE. SINCE THEIR RESULTS HAVE BEEN KNOWN, THEY HAVE REDUCED THEIR USE OF BIOGLUE SINCE THEY CONSIDER THE RISK OF INFECTION TO BE TOO HIGH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOGLUE SURGICAL ADHESIVE | SURGICAL ADHESIVE | MUQ | CRYOLIFE, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |