Sat., 10/15/11 Recon, UE, Wrist & Hand, Paper #83, 3:36 pm OTA-2011
•Does BMP-2 Increase the Incidence of Perioperative Wound Complications or Reoperation?
Daniel Steven Chan, MD1; Joshua Garland, MD2; Anthony F. Infante, Jr., DO1;
Roy Sanders, MD1; H. Claude Sagi, MD1;
1Orthopaedic Trauma Service, Florida Orthopaedic Institute, Tampa, Florida, USA;
2Naval Medical Center, Portsmouth, Virginia, USA
Purpose: The purpose of this study is to document the incidence of postoperative wound complications thought to be directly attributable to the use of bone morphogenetic protein–2 (BMP-2) in a large series of patients for both acute traumatic and reconstructive extremity cases. Our hypothesis was that BMP-2 contributed to these wound complications.
Methods: A retrospective chart review was performed on cases between January 1, 2002 and December 31, 2009 in which Infuse BMP-2 was used in acute trauma (open fractures) or posttraumatic reconstruction (nonunion repair). The following data were collected: age, surgical site, purpose (acute vs reconstructive), type of supplemental bone graft used, associated wound factors (open fractures, soft-tissue injury requiring coverage, or history of infection), signs of infection (seroma, erythema, prolonged drainage, abscess), the need for reoperation secondary to wound complication, and union. These cases were then compared to 1:1 matched cohorts for age, type of case (acute/reconstructive), anatomic site, open injury, and soft-tissue reconstruction.
Results: A total of 193 BMP-2 cases were reviewed. There were 138 nonunions and 56 open fractures. Sixty patients (31%) had documentation of at least 1 postoperative wound concern. There was no difference between the acute traumatic and reconstructive groups. The most commonly documented (29%) wound concern was prolonged serous drainage. 17 patients (9%) required postoperative antibiotic therapy longer than would routinely have been prescribed. Six patients (3%) required reoperation for presumed wound infection secondary to prolonged drainage and erythema. Four of the six patients (2%) had infection and two (1%) had a sterile seroma/hematoma. Age, sex, anatomic site, acute trauma, open fracture, and the need for soft-tissue reconstruction did not correlate with the need for return to the operating room for presumed or actual wound infection. There were 182 patients in the matched control cohort. 33 patients (18%) had documentation of at least 1 wound concern; significantly less than with BMP-2 use (P = 0.004). The most common concern was wound drainage (22 out of 33). 15 patients (8%) required a reoperation for wound infection after prolonged drainage or wound dehiscence—significantly higher than the BMP-2 group (P = 0.04). Among the wound concern subgroups, the reoperation incidence in BMP-2 patients was significantly lower (P <0.0001). The most common anatomic site that required a reoperation was the distal tibia (11 out of 15).
Conclusion: The use of BMP-2 in both acute and reconstructive extremity surgery increased the incidence of prolonged serous drainage requiring additional antibiotic therapy that typically resolves. This does not appear to be indicative of a postoperative infection requiring a reoperation. Importantly, reoperations for presumed wound infection were significantly lower than in the matched group of cohorts. We suggest that when postoperative drainage is seen after the use of BMP-2, treatment should be limited to antibiotic coverage until the wound resolves.
Alphabetical Disclosure Listing (628K PDF)
• The FDA has not cleared this drug and/or medical device for the use described in this presentation (i.e., the drug or medical device is being discussed for an “off label” use). ◆FDA information not available at time of printing. Δ OTA Grant.