Adhesive-Enhanced Sternal Closure to Improve Postoperative Functional Recovery: A Pilot, Randomized Controlled Trial

Fedak, Paul W.M.; Kieser, Teresa M.; Maitland, Andrew; Holland, Margaret; Kasatkin, Aleksey; LeBlanc, Pamela; Kim, Jae K.; King, Kathryn M.

doi:10.1016/j.athoracsur.2011.05.014

Cited by 44 publications

(41 citation statements)

References 22 publications

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“…Due to physical changes occurring through ageing and presence of disabilities, this period may be even longer in the elderly jeopardizing daily functions. In a previous study, patients with adhesive-enhanced closure have been shown to have accelerated recovery of health-related quality of life and a reduction in overall physical disability in the postoperative period compared with control patients [18]. Similarly, reduced postoperative pain, improved respiration, increased mobility and accelerated recovery have been observed in our patients, resulting in good quality of life after conventional cardiac surgery.…”

Section: Discussionsupporting

confidence: 65%

“…It is also worth remembering that the use of strong narcotics in the elderly patients can have serious side effects such as hallucinations, confusion and disabling falls [17]. In this regard, kryptonite bone cement was previously shown to be associated with significantly less pain, less requirement for analgesia, and a faster return to baseline pulmonary functions in a total of 34 patients [18]. Similarly, most of our patients did not experience severe postoperative pain with kryptonite bone cement, including those with arthritic conditions.…”

Section: Discussionmentioning

confidence: 99%

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Bone cement-enhanced sternal closure technique in cardiac surgery: effects on sternal union, pain and life quality

Bayramoğlu

Durak

Bayram

et al. 2013

J Cardiothorac Surg

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BackgroundMedian sternotomy provides excellent access to all mediastinal structures in patients undergoing conventional cardiovascular surgery. Although this incision technique is associated with relatively lower complication rates, certain complications such as the sternal dehiscence may pose serious health consequences. In this regard, considerable effort has been paid to develop techniques aiming to improve sternal healing and to enhance postoperative recovery after conventional cardiac surgery. Among these, kryptonite bone cement, a biocompatible polymer with improved mechanical properties when combined with a standard wire cerclage, represents a promising novel approach that may help prevent sternal dehiscence. In this study, the effects of this particular type of bone cement on sternal healing, postoperative pain, and quality of life have been evaluated.MethodsKryptonite bone cement enhanced sternal closure was employed in a total of 100 patients undergoing conventional cardiac surgery between November 2009 and June 2012. Of these patients, 50 expressed their willingness to participate in this study. Each participant underwent a computerized tomography imaging for the radiological assessment of sternal healing. Pain and life quality of these patients have been evaluated by Wong-Baker faces pain scale and SF-36 health survey questionnaire, respectively.ResultsMean duration of follow-up was 20.14 ± 7.36 months (range: 10–32). Mean age and body mass index were 71.32 ± 7.23 years (range: 55–85) and 28.34 ± 2.62 (21–34) kg/m2, respectively. Elderly patients (≥70), females and those with chronic obstructive pulmonary disease (COPD) comprised 64%, 26% and 40% of the study population, respectively. No patients had findings suggestive of dehiscence on CT images. No patients reported severe pain (i.e. all patients had a Wong-Baker faces pain scale score <4). Elderly (≥ 70 yr) subjects had better quality of life scores as compared to the remaining group of patients (< 70 yr) according to SF-36 Health Survey results. Vitality and emotional role scores were lower (63.5 ± 25.5, p = 0.018 and 41.7 ± 23.3, p = 0.001, respectively) in female patients. Patients with COPD had lower quality of life scores than those without COPD, particularly with respect to general health scores (73.3 ± 18.5; p = 0.012).ConclusionsKryptonite bone cement, when combined with a standard wire cerclage, enhances mechanical strength, prevents sternal dehiscence, reduces postoperative pain and improves quality of life after conventional cardiac surgery. Long-term studies are warranted to better define the role of kryptonite bone cement in the prevention of sternal dehiscence.

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Section: Discussionsupporting

confidence: 65%

Section: Discussionmentioning

confidence: 99%

Bone cement-enhanced sternal closure technique in cardiac surgery: effects on sternal union, pain and life quality

Bayramoğlu

Durak

Bayram

et al. 2013

J Cardiothorac Surg

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“…The aims of this restriction are to promote sternal osteosynthesis and bone healing by minimising motion between the sternal edges [8, 15, 63]. However, the effect of sternal precautions on patient outcomes is unknown, with significant variation among institutions worldwide [8, 13, 14, 26].…”

Section: Discussionmentioning

confidence: 99%

The Sternal Management Accelerated Recovery Trial (S.M.A.R.T) – standard restrictive versus an intervention of modified sternal precautions following cardiac surgery via median sternotomy: study protocol for a randomised controlled trial

Katijjahbe

Denehy

Granger

et al. 2017

Trials

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BackgroundThe routine implementation of sternal precautions to prevent sternal complications that restrict the use of the upper limbs is currently worldwide practice following a median sternotomy. However, evidence is limited and drawn primarily from cadaver studies and orthopaedic research. Sternal precautions may delay recovery, prolong hospital discharge and be overly restrictive. Recent research has shown that upper limb exercise reduces post-operative sternal pain and results in minimal micromotion between the sternal edges as measured by ultrasound. The aims of this study are to evaluate the effects of modified sternal precautions on physical function, pain, recovery and health-related quality of life after cardiac surgery.Methods/designThis study is a phase II, double-blind, randomised controlled trial with concealed allocation, blinding of patients and assessors, and intention-to-treat analysis. Patients (n = 72) will be recruited following cardiac surgery via a median sternotomy. Sample size calculations were based on the minimal important difference (two points) for the primary outcome: Short Physical Performance Battery. Thirty-six participants are required per group to counter dropout (20%). All participants will be randomised to receive either standard or modified sternal precautions. The intervention group will receive guidelines encouraging the safe use of the upper limbs. Secondary outcomes are upper limb function, pain, kinesiophobia and health-related quality of life. Descriptive statistics will be used to summarise data. The primary hypothesis will be examined by repeated-measures analysis of variance to evaluate the changes from baseline to 4 weeks post-operatively in the intervention arm compared with the usual-care arm. In all tests to be conducted, a p value <0.05 (two-tailed) will be considered statistically significant, and confidence intervals will be reported.DiscussionThe Sternal Management Accelerated Recovery Trial (S.M.A.R.T.) is a two-centre randomised controlled trial powered and designed to investigate whether the effects of modifying sternal precautions to include the safe use of the upper limbs and trunk impact patients’ physical function and recovery following cardiac surgery via median sternotomy.Trial registrationAustralian and New Zealand Clinical Trials Registry identifier: ACTRN12615000968572. Registered on 16 September 2015 (prospectively registered).Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-1974-8) contains supplementary material, which is available to authorized users.

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“…Kryptonite TM cement (a polymeric material synthesised from castor oil and calcium carbonate powder) has been shown to prevent sternal displacements when used in conjunctions with wires cerclage closure due to good adhesive and strength properties [4,51]. In addition, it has been shown to have bioabsorbable and osteoconductive properties [52,53].…”

Section: Introductionmentioning

confidence: 99%

A Novel Glass Polyalkenoate Cement for Fixation and Stabilisation of the Ribcage, Post Sternotomy Surgery: An ex-Vivo Study

Alhalawani

Curran

Pingguan‐Murphy

et al. 2013

JFB

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This study investigates the use of gallium (Ga) based glass polyalkenoate cements (GPCs) as a possible alternative adhesive in sternal fixation, post sternotomy surgery. The glass series consists of a Control (CaO–ZnO–SiO2), and LGa-1 and LGa-2 which contain Ga at the expense of zinc (Zn) in 0.08 mol% increments. The additions of Ga resulted in increased working time (75 s to 137 s) and setting time (113 to 254 s). Fourier Transform Infrared (FTIR) analysis indicated that this was a direct result of increased unreacted poly(acrylic acid) (PAA) and the reduction of crosslink formation during cement maturation. LGa samples (0.16 wt % Ga) resulted in an altered ion release profile, particularly for 30 days analysis, with maximum Ca2+, Zn2+, Si4+ and Ga3+ ions released into the distilled water. The additions of Ga resulted in increased roughness and decreased contact angles during cement maturation. The presence of Ga has a positive effect on the compressive strength of the samples with strengths increasing over 10 MPa at 7 days analysis compared to the 1 day results. The additions of Ga had relatively no effect on the flexural strength. Tensile testing of bovine sterna proved that the LGa samples (0.16 wt % Ga) are comparable to the Control samples.

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Adhesive-Enhanced Sternal Closure to Improve Postoperative Functional Recovery: A Pilot, Randomized Controlled Trial

Cited by 44 publications

References 22 publications

Bone cement-enhanced sternal closure technique in cardiac surgery: effects on sternal union, pain and life quality

Bone cement-enhanced sternal closure technique in cardiac surgery: effects on sternal union, pain and life quality

The Sternal Management Accelerated Recovery Trial (S.M.A.R.T) – standard restrictive versus an intervention of modified sternal precautions following cardiac surgery via median sternotomy: study protocol for a randomised controlled trial

A Novel Glass Polyalkenoate Cement for Fixation and Stabilisation of the Ribcage, Post Sternotomy Surgery: An ex-Vivo Study

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