Incidence Of Sternal Dehiscence Research Articles

A Randomized Study Evaluating Clinical Efficacy and Safety of Trusteel® and Ethisteel® Surgical Steel Sutures for Sternal Closure in Subjects Undergoing Surgical Procedures by Sternotomy.

Sternal dehiscence and other post-sternotomy complications, viz. superficial and deep sternal wound infection, mediastinitis, and sternal instability increase the risk of mortality. Sternotomy closure with steel sutures results in a low complication rate. Therefore, this study compared the clinical equivalence of Trusteel® (Healthium Medtech Limited, Bengaluru, India) and Ethisteel® (Ethicon, Johnson & Johnson,Cincinnati, USA) surgical steel sutures for sternal closure following median sternotomy. The primary endpoint of this prospective, single-blind, multicentric, two-arm, randomized (1:1) study (April 2021-April 2023) was a comparison of the proportion of subjects having sternal dehiscence within 26 weeks of the median sternotomy closure between Trusteel® (n=33) and Ethisteel® (n=34) groups. Secondary endpoints comprisedan assessment of intraoperative suture handling, the incidence of mortality and other complications of sternal closure, operative time, intensive care unit (ICU)/hospital stay, return to normal day-to-day activities and work, subject satisfaction and general well-being, and adverse events in both groups. A statistically significant result between the groups was considered at p<0.05. No incidence of sternal dehiscence or other post-operative complications were recorded. A significant difference (p<0.05) in the stretch capacity of Trusteel® and Ethisteel® sutures was noted; otherwise, ease of passage, knot holding, knot security, knot tie-down smoothness, and memory of both sutures had comparable ratings. Operative time, ICU/hospital stay, and return to normal day-to-day activities and work were comparable between the groups. Improvement in post-operative functional abilities, quality of life, and health status was evident in both groups and was comparable. Trusteel® surgical steel suture is clinically equivalent to Ethisteel® surgical steel suture and is safe and effective for sternal closure following median sternotomy.

Evaluating the Clinical Equivalence of Truwax® and Ethicon® Bone Waxes for Sternal Wound Hemostasis: A Prospective Randomized Study.

Incidence of sternal dehiscence, wound infection, and mortality are prevalent following sternotomy. Bone wax is widely used over the sternal edges for augmenting hemostasis. This study evaluated the clinical equivalence of Truwax® (Healthium Medtech Limited, Bengaluru, India) with Ethicon® (Johnson & Johnson, New Brunswick, New Jersey, United States) bone wax for sternal wound hemostasis in subjects undergoing surgical procedures by sternotomy. The primary endpoint of this prospective (May 2022-April 2023), parallel-group, two-arm, randomized, single-blind, multicenter study was to evaluate the proportion of subjects having sternal dehiscence within 26 weeks of median sternotomy closure. Secondary endpoints assessed the average time to hemostasis on sternum sides, bone wax properties, number of dressing changes, sternal bone instability (clinically/chest radiography), pain, perioperative/postoperative complications, blood and blood products used, duration of intensive care unit (ICU)/hospital stay, reoperations, time taken to return back to work and normal day-to-day activities, subject satisfaction and quality of life (QoL), and adverse events. A probability of <0.05 was considered significant. No incidence of sternal dehiscence or postoperative complications was witnessed. Time to hemostasis, bone wax properties, number of dressing changes, sternal stability, pain, blood and blood products used, duration of ICU/hospital stay, reoperations, time taken to return back to normal day-to-day activities and to work, and subject satisfaction and QoL were comparable between Truwax® and Ethicon® bone wax groups. Truwax® and Ethicon® bone waxes are safe and effective and provide sternal wound hemostasis in people undergoing sternotomy.

Sternum Dehiscence: A Preventable Complication of Median Sternotomy.

The incidence of sternal dehiscence following cardiothoracic surgery via sternotomy is rare. It causes serious patient dissatisfaction and leads to higher hospital costs. For years, each clinic has made efforts to reduce this complication. Here, we aimed to summarize our techniques to prevent dehiscence. This retrospective study included two groups operated via median sternotomy from March 2009 to May 2019. The first group included 1,105 consecutive patients who only received sternum wire for sternum closure from March 2009 to October 2013. The second group included 1,559 consecutive patients operated from January 2014 to May 2019; preventive closure techniques were performed for predefined high-risk patients in this group. These closure techniques included polyglyconate (Maxon) or simple longitudinal reinforced sutures, sternal cable or sternoband, sternal plate, and Robiscek technique. All patients in Group 1, and 63.8% (995/1559) patients in Group 2 received sternal wire only (P < .001). In Group 2, we applied preventive closure techniques to 564 (36.2%) patients. There was no sternal dehiscence in Group 2, whereas 29 (2.6%) patients postoperatively suffered sternal dehiscence in Group 1; this was statistically significant (P = .001, OR:85.5, 95%CI:5.22-1400.4). The overall incidence of mediastinitis was 0.94%. The incidence significantly was lower in Group 2 (P = .004, OR:3.6, 95%CI:1.52-8.82). Sternum-related mortality in Group 2 also was lower (0.54% versus 0.06%, P = .048, OR:8.5, 95% CI: 1.02-70.75). Sternal dehiscence can be avoided by careful perioperative risk assessment and enhanced closure techniques. The same special consideration may significantly reduce mediastinitis and sternal-related mortality.

Application of new chest holder in the median sternotomy for open heart surgery in adults

Objective: To explore the application of new chest holder in the median sternotomy for open heart surgery in adults. Methods: Two hundred adult patients in Henan Provincial People's Hospital from May 2013 to May 2015 were enrolled in the study and randomly divided into two groups. Experimental group included 100 cases who accepted the new type of chest holder in the open heart surgery. Control group were also composed of 100 cases whose sternums were fixed with the pure steel wire cerclage. Sternal closure time was recorded since the sternum closing. All subjects were followed up to obtain the chest incision healing, the incidence of sternal dehiscence, infection and secondary thoracotomy, and thus to estimated the effect of new chest holder. Results: All patients in the experimental group reached the effect of firm closed chest surgery. Sternal closure time of experimental group was much shorter than that of control group[(10±2) vs (21±4) min, P<0.001]. No sternal instability, dehiscence, infection and secondary thoracotomy were found during the follow-up. However, in the control group, 3 secondary thoracotomy cases, 6 sternal dehiscence cases and 2 sternal infection cases were detected. Conclusions: New type of chest holder in the median sternotomy for open heart surgery is more convenient with small surgical trauma. It can also effectively reduce the incidence of sternal instability, dehiscence, infection and secondary thoracotomy.

Cabled Butterfly Closure: A Novel Technique for Sternal Closure

Impaired sternal wound healing remains problematic after median sternotomy and can lead to significant morbidity after cardiac surgical procedures. Although metal plating systems exist for closing the sternum, their use is limited by expense and practicality, and simple wire closure remains the most common technique to close the sternum. We describe a cabling technique for sternal closure that is secure, uses standard sternal wire, and may be used on every patient. We have used the technique routinely in 291 patients with no sternal dehiscence or wound healing problems.

Sternal fixation using new synthetic cable ties implants (Zip-Fix® System)

Objectives: Sternal dehiscence is a severe complication in cardiac surgical procedures using mid sternotomy as the standard access. Alternative techniques to traditional wiring may reduce the incidence of sternal dehiscence. Methods: In this initial observational study, we present an alternative technique for sternal osteosynthesis, the use of synthetic bands, like cable-ties, made of biocompatible polyether-etherketon (PEEK) to be implanted peristernally. These implants have a larger implant to bone contact area and show a 5 times higher degree of resilience. Results: We performed primary sternal fixation using ZipFix in 31 pts. (from 5/2011 to 9/2011) after mid sternotomy for standard cardiac surgical procedures (CABG: 85%; AVR: 11%; others (HTX): 4%). In this cohort, mean age was 68y (40% over 75y old), 37% had diabetes mellitus, COPD occurred in 30%. The mean body weight was 92.6kg±15.6kg, (range 64–134); mean Obesity (BMI>25) was present in 87%, malignant obesity (BMI >40) in 13%; heavy- weighted patients, i.e. more than 100kg, were present in 35% of patients. Secondary wound dehiscence occurred in two patients (122kg and 134kg) of 28 (7%), due to marginal transsection of the sternum. Conclusions: The cable ties technique using ZipFix is an appropriate device to reduce the incidence of sternal dehiscence after mid sternotomy in patients at high risk for sternal dehiscence. Parasternal implantation technique is recommended. Additional use of wires in the manubrium sterni is optional. As the incidence of obesity is steadily increasing, a more frequent use is expected in the future.

Figure-of-Eight vs. Interrupted Sternal Wire Closure of Median Sternotomy

Sternal dehiscence is a rare but devastating complication following median sternotomy for cardiac surgery. The optimal technique for sternal closure is unclear. We conducted this prospective randomized trial to compare the incidence of sternal dehiscence after figure-of-8 and simple interrupted suturing in patients undergoing coronary artery bypass grafting. Between January 2007 and June 2008, 98 patients had figure-of-8 suturing and 97 had interrupted sutures. The mean age of the patients was 60.9 +/- 7.6 years. The overall sternal dehiscence rate was 8%; 7 cases in the in figure-of-8 group and 9 in the interrupted group. Thirteen patients had no wound infection and healed with conservative treatment. Only 3 patients had sternal dehiscence with infection: 2 with simple interrupted closure and 1 with figure-of-8 sternal closure. There was no significant difference in rates of sternal dehiscence between the 2 groups. It was concluded that figure-of-8 sternal suturing is equally effective as simple interrupted suturing in preventing sternal dehiscence.

Is Allogeneic Blood Transfusion a Risk Factor for Sternal Dehiscence Following Cardiac Surgery? A Prospective Observational Study

Sternal dehiscence following cardiac surgery has a multifactorial etiology. Significant risk factors contributing to sternal dehiscence include chronic obstructive pulmonary disease (COPD), obesity, or re-exploration due to bleeding or pericardial tamponade. We have focused on the role of allogeneic blood transfusion as a factor leading to the poor healing of surgical wounds. A prospective observational study of 1553 elective and emergency cardiac surgery patients was performed between January 2003 and June 2007. All of the patients enrolled in this study underwent median sternotomy. We studied the relationship between sternal dehiscence following cardiac surgery and the total number of packed red blood cells transfused. The incidence of sternal dehiscence in the study group was 3.4%. Diabetic patients did not have a higher incidence of wound dehiscence. Although COPD, obesity, and re-exploration contributed to sternal dehiscence, the number of allogeneic blood transfusions during the perioperative period was an important independent risk factor for sternal dehiscence. Patients with sternal dehiscence received an average of 7.6 transfusion units (TU) of allogeneic blood versus 1.6 TU of allogeneic blood in the group without sternal dehiscence (P < 0.00005). The dehiscence affected patients without any other significant risk factor who received 6 or more TU, or patients with at least one significant risk factor who received 4 or more TU of allogeneic blood. According to our results, the total amount of allogeneic blood transfused is an important risk factor contributing to sternal dehiscence. Regardless of other risk preconditions, the transfusion of 6 or more TU could result in sternal dehiscence following cardiac surgery.

Influence of sternal closure technique on the incidence of sternal dehiscence and sternal wound infection

Objectives: Sternal closure is a key component for the prevention of sternal dehiscence (SD) and subsequent superficial (SSWI) and/or deep sternal wound infection (DSWI). This study analysis the influence of different sternal closure techniques on SD and DSWI.

Modified closure technique for reducing sternal dehiscence; a clinical and in vitro assessment

Although the incidence of sternal dehiscence is low its mortality can be high. An alternative technique is described (modified closure) which aims to redistribute the dehiscence force into the longer longitudinal axis rather than the shorter transverse axis, thereby maximising the closure strength. Four ethibond sutures, which interlock anteriorly, are used in addition to eight transverse sternal wires. The aim of the study was to assess the modified closure using both an in vitro and a clinical study. (a) In vitro study: A weight and traction pulley system applied a force of 0.1kN to pairs of silicone rubber hemisterna approximated to each other using alternative closure techniques. The dehiscence tendency (DT) was measured as the amount of separation under tension. Using 10 pairs of hemisterna for each closure technique the measured DT for the modified closure (MC) was compare with those for each of five alternative closures (two figure-of-eight and four transverse sutures (2C), 6 (6T), 8 (8T), 10 (10T) and 12 transverse sutures (12T)). (b) Clinical study: The incidence of sternal dehiscence for the first 4 years of a consultants' practice (using 8T) was compared with the second 4 years (using MC). (a) Measured DT (mean+/-SEM), (MC: 149+/-14; 6T: 256+/-13; 8T: 223+/-9; 10T: 213+/-13; 12T: 203+/-8; 2C: 294+/-15). DT was significantly smaller for MC (p<0.003). (b) The incidence of dehiscence was significantly smaller in the second 4 years (MC) than in the first (8T): 0.2% (1/529) versus 1.6% (13/788); p=0.01 In vitro and clinical studies suggest that the modified closure technique can reduce the incidence of sternal dehiscence.

Clinical Outcomes of Noninfectious Sternal Dehiscence After Median Sternotomy

Infectious complications of median sternotomy carry significant morbidity and mortality. However, the outcomes of noninfectious sternal dehiscence have not been addressed. We have identified the preoperative characteristics, postoperative complications, and long-term functional outcomes of patients after reoperation for noninfectious sternal dehiscence and compared these patients with a control group to determine risk factors for dehiscence. Retrospective review of the cardiac surgery database identified 48 patients with noninfectious sternal dehiscence in a group of 12,380 median sternotomies between 1994 and 2004. The review included diagnosis, demographics, concomitant medical conditions, and surgical outcomes. Functional outcomes were assessed using the Short Form-12 questionnaire. One hundred fifty-six median sternotomy patients served as controls. Follow-up was 97.9% (47 of 48 patients) complete, for a total of 150.1 patient-years. Mean age of patients at reoperation was 58.8 +/- 12.8 years, with a male to female ratio of 45:3. Multivariate analysis determined that New York Heart Association class IV, obesity, and chronic obstructive pulmonary disease were preoperative risk factors for sternal dehiscence. The incidence of sternal dehiscence was 0.39% at a mean interval between initial operation and reoperation of 5.4 months. At a mean interval of 3.9 months, 14.6% (7 of 48) of patients required additional sternal procedures. Infectious complications after reoperation occurred in 12.5% (6 of 48). Functional outcomes demonstrated that 72.2% (26 of 36) had no or mild limitation of physical activities, with 90.5% (38 of 42) reporting no or mild sternal pain at follow-up. Although patients undergoing surgical correction of noninfectious sternal dehiscence fare better than those with infectious complications, optimal sternal approximation during the initial procedure and sternal precautions during convalescence should be emphasized to prevent recurrent complications.

Is Extreme Obesity a Risk Factor for Increased In-Hospital Mortality and Postoperative Morbidity after Cardiac Surgery? Results of 2251 Obese Patients with BMI of 30 to 50

The number of patients with extreme obesity requiring cardiac surgery is increasing. The aim of the present study was to evaluate the perioperative outcome, complication rate and 30-day mortality of these patients. Data of 13 139 patients (9584 males, 3555 females) undergoing cardiac surgery from 1/94 to 12/04 were analyzed. We compared 2251 obese patients with a BMI of 30 to 50 (mean age 64.3 years; group A) with 10 888 non-obese patients (mean age 66.1 years; group B). The incidence of diabetes mellitus was 34.5 % in group A, and 24.2 % in group B. Isolated CABG was performed in 1771 patients from group A (3.4 grafts/pt.) and in 8066 patients from group B (3.2 grafts/pt.). Concomitant procedures were performed in 460 patients (group A) vs. 2645 (group B). Frequency of bilateral internal thoracic artery grafting was 49.4 % (group A) vs. 44.9 % (group B). There were no significant differences between the two groups with regard to the duration of surgery (180 vs. 171 min), the number of reoperations for bleeding (4.7 % vs. 5.0 %), ventilation times, length of stay in the intensive care unit (2.6 vs. 2.4 days) or 30-day mortality (2.0 % vs. 2.8 %). The incidence of diabetes and occurrence of sternal dehiscence was higher in group A (1.6 % vs. 0.7 %; P < 0.01). Sternal complications were strongly associated with diabetes and the combined use of bilateral ITA grafts but not with isolated obesity. The incidence of sternal dehiscence was associated with the male gender (group A 1.9 % vs. 0.7 %; group B 0.9 % vs. 0.3 %). Severe obesity does not PER SE enhance perioperative mortality. A BMI of 30 to 50 combined with diabetes mellitus and bilateral ITA grafting increases the risk for sternal complications.