Background: Most cardiac surgery patients undergo median sternotomy during open heart surgery. Sternotomy healing is an arduous, very complex, and multifactorial process dependent on many independent factors affecting the sternum and the surrounding soft tissues. Complication rates for median sternotomy range from 0.5 to 5%; however, mortality rates from complications are very variable at 7-80%. Low calcidiol concentration below 80 nmol/L results in calcium absorptive impairment and carries a risk of bone loss, which is considered as a risk factor in the sternotomy healing process. The primary objective of this clinical trial is to compare the incidence of all postoperative sternotomy healing complications in two parallel patient groups administered cholecalciferol or placebo. The secondary objectives are focused on general patient recovery process: sternal bone healing grade at the end of the trial, length of hospitalization, number of days spent in the ICU, number of days spent on mechanical lung ventilation, and number of hospital readmissions for sternotomy complications.
Methods: This clinical trial is conducted as monocentric, randomized, double-blind, placebo-controlled, with planned enrollment of 600 patients over 4 years, approximately 300 in the placebo arm and 300 in the treatment arm. Males and females from 18 to 95 years of age who fulfill the indication criteria for undergoing cardiac surgery with median sternotomy can be included in this clinical trial, if they meet the eligibility criteria.
Discussion: REINFORCE-D is the first monocentric trial dividing patients into groups based on serum calcidiol levels, and with dosing based on serum calcidiol levels. This trial may help to open up a wider range of postoperative healing issues.
Trial Registration: EU Clinical Trials Register, EUDRA CT No: 2016-002606-39 . Registered on September 8, 2016.
Download full-text PDF |
Source |
---|---|
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7731517 | PMC |
http://dx.doi.org/10.1186/s13063-020-04920-z | DOI Listing |
Front Pediatr
December 2024
Department of PICU (or Pediatric Research Institute), Children's Hospital of Chongqing Medical University, Chongqing, China.
Deep sternal wound infection (DSWI) is a rare but potentially devastating complication of median sternotomy performed in cardiac surgery. This report summarizes the nursing management of two pediatric cases with a DSWI treated using Do It Yourself (DIY) negative pressure suction (DIY-NPS) after surgery. The technique maintains a continuous suction pressure of 75 mmHg and intermittently flushes small volumes of fluid to stimulate granulation tissue formation and control systemic infection.
View Article and Find Full Text PDFClin Case Rep
December 2024
Department of Cardiothoracic Surgery HonorHealth Scottsdale Arizona USA.
Patent foramen ovale (PFO) closure using percutaneous devices, such as the Amplatzer occluder, is a common treatment for patients with a history of cryptogenic stroke or transient ischemic attack (TIA). Although generally well-tolerated, some patients may develop adverse reactions to the device materials, particularly in the presence of a nickel allergy. Symptoms can include chest pain, rashes, and migraines, which may necessitate surgical removal of the device.
View Article and Find Full Text PDFJ Clin Med
December 2024
Silesian Centre for Heart Diseases in Zabrze, Department of Cardiac, Vascular and Endovascular Surgery and Transplantology, Medical University of Silesia, 40-055 Katowice, Poland.
Median sternotomy is one of the most common procedures in cardiac surgery. This corresponds to the relatively high frequency of infections where surgical incisions are performed. In the prevention of healing disorders, the medical staff intervention is important, as is the patient.
View Article and Find Full Text PDFCureus
November 2024
Department of Research, MTF Biologics, Edison, USA.
Objectives Wound dehiscence is defined as the partial or complete separation of the layers of a surgical wound. Wound dehiscence and infections are of significant concern in the field of surgery as they can lead to a range of complications, including infection, delayed healing, increased healthcare costs, and patient discomfort. For patients at high risk of sternal wound dehiscence and infection, optimization of wound closure is critical.
View Article and Find Full Text PDFJ Clin Med
October 2024
Faculty of Medicine Carl Gustav Carus, TU Dresden, 01307 Dresden, Germany.
: Minimally invasive cardiac surgery is often avoided in patients with obesity due to exposure and surgical access concerns. Nonetheless, these patients have elevated periprocedural risks. Minimally invasive transaxillary aortic valve surgery offers a sternum-sparing "nearly no visible scar" alternative to the traditional full sternotomy.
View Article and Find Full Text PDFEnter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!