title: Adhesive-enhanced sternal closure to improve postoperative functional recovery: a pilot, randomized controlled trial.
abstract: BACKGROUND
  We previously established a proof-of-concept in a human cadaveric model where conventional wire cerclage was augmented with a novel biocompatible bone adhesive that increased mechanical strength and early bone stability. We report the results of a single-center, pilot, randomized clinical trial of the effects of adhesive-enhanced closure of the sternum on functional postoperative recovery.
  
  
  METHODS
  In 55 patients undergoing primary sternotomy, 26 patients underwent conventional wire closure and were compared with 29 patients who underwent adhesive-enhanced closure, which consisted of Kryptonite biocompatible adhesive (Doctors Research Group Inc, Southbury, CT) applied to each sternal edge in addition to conventional 7-wire cerclage. Patients were monitored postoperatively at 72 hours, weekly for 12 weeks, and then after 12 months for incisional pain, analgesic use, and maximal inspiratory capacity measured by spirometry. Standardized assessment tools measured postoperative physical disability and health-related quality of life.
  
  
  RESULTS
  No adverse events or sternal complications from the adhesive were observed early or after 12 months. Incisional pain and narcotic analgesic use were reduced in adhesive-enhanced closure patients. Inspiratory capacity was significantly improved, postoperative health-related quality of life scores normalized more rapidly, and physical disability scores were reduced. Computed tomography imaging was suggestive of sternal healing.
  
  
  CONCLUSIONS
  Adhesive-enhanced closure is a safe and simple addition to conventional wire closure, with demonstrated benefits on functional recovery, respiratory capacity, incisional pain, and analgesic requirements. A large, multicenter, randomized controlled trial to examine the potential of the adhesive to prevent major sternal complications in higher risk patients is warranted.
authors.affiliation: Department of Cardiac Sciences, University of Calgary, Calgary, Alberta, Canada. paul.fedak@gmail.com
authors.forename: Paul W M
authors.initials: PW
authors.lastname: Fedak
authors.forename: Teresa M
authors.initials: TM
authors.lastname: Kieser
authors.forename: Andrew M
authors.initials: AM
authors.lastname: Maitland
authors.forename: Margaret
authors.initials: M
authors.lastname: Holland
authors.forename: Aleksey
authors.initials: A
authors.lastname: Kasatkin
authors.forename: Pamela
authors.initials: P
authors.lastname: Leblanc
authors.forename: Jae K
authors.initials: JK
authors.lastname: Kim
authors.forename: Kathryn M
authors.initials: KM
authors.lastname: King
mesh_terms: D006348:Cardiac Surgical Procedures / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006331:Heart Diseases / Q000601:surgery; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D019106:Postoperative Hemorrhage / Q000517:prevention & control*; D020127:Recovery of Function; D012189:Retrospective Studies; D016037:Single-Blind Method; D056346:Sternotomy; D013529:Surgical Wound Dehiscence / Q000517:prevention & control*; D013536:Suture Techniques; D014014:Tissue Adhesives / Q000008:administration & dosage*; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects / Q000502:physiology*
chemical_list: D014014:Tissue Adhesives