Clinical trials: Sternal Injury
Sternal Wound Repair
Effects of Platelet Rich Fibrin (PRF) in Treatment of Non-healing Sternum Wound After Open-heart Surgery
Sternal wound and there complication such as infection, Bruising and scar formation are known as major complication cardiac surgery with a high mortality rate up to 50%.
- Trial name
- NCT03183973
- Testing
- PRF
- Where
- Iran
- Volunteers
- 45 people
- Sponsor
- SCARM Institute, Tabriz, Iran
Sternal Wound Complications, Obesity (Body Mass Index >30 kg/m2)
Sternal Closure in High-BMI Patients: Cable vs Wire
This retrospective study compares two sternal closure techniques-standard stainless-steel wires and rigid cable systems-in adult patients with a body mass index (BMI) ≥30 who underwent open-heart surgery between January 1, 2020…
- Conditions
- Sternal Wound Complications, Obesity (Body Mass Index >30 kg/m2), Median Sternotomy, Cardiac Surgery
- Trial name
- NCT07097272
- Where
- Turkey (Türkiye)
- Volunteers
- 110 people
- Sponsor
- Samsun University
Post-Sternotomy Deep Sternal Wound Infection
Vancomycin and Negative Pressure Therapy for Post-sternotomy Deep Sternal Wound Infection
Only a limited number of studies have been published that monitored the penetration of antibiotics from blood into exudate in patients treated with negative pressure wound therapy (NPWT), and that evaluated the adequacy of…
- Trial name
- NCT06506032
- Testing
- Intravenous Vancomycin administration, Standard postoperative therapy
- Where
- 5 sites in Czechia
- Volunteers
- 10 people
- Sponsor
- University Hospital Ostrava
Blunt Chest Wall Trauma, Rib Fracture
Intercostal Liposomal Bupivacaine for the Management of Blunt Chest Wall Trauma
This is a study of liposomal bupivacaine for pain control in patients with blunt chest wall trauma.
- Conditions
- Blunt Chest Wall Trauma, Rib Fracture, Sternal Fracture
- Trial name
- NCT02749968
- Testing
- Liposomal bupivacaine, 0.9% sodium chloride
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of Cincinnati
Coronary Artery Bypass Graft, Median Sternotomy
Risk Factors of Sternal Wound Infection After Coronary Artery Bypass Graft
The investigators are trying to evaluate the performance of neutrophil and lymphocyte counts as a risk factor of deep sternal wound infection after coronary artery bypass graft surgery.
- Trial name
- NCT01629030
- Where
- South Korea
- Volunteers
- 1,850 people
- Sponsor
- Samsung Medical Center
Sternal Wound Infection, Mediastinitis
Rapid Sternal Closure System (TALON)
The primary objective is to establish if the Rapid Sternal Closure System (RSCS) improves early postoperative recovery as manifested by decreased pain and improved pulmonary function.
- Trial name
- TALON (NCT00638014)
- Testing
- Rapid Sternal Closure System, Conventional wire closure
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Duke University
Cardiovascular Disease, Surgical Site Infection
Innovative Sternal Closure Techniques: Evaluating STRATAFIX™ and DERMABOND™ for Reduced Complications in CABG Patients
The goal of this clinical trial is to learn if a new method of closing the breastbone after heart bypass surgery can improve healing and reduce complications in adults undergoing coronary artery bypass graft (CABG) surgery.
- Conditions
- Cardiovascular Disease, Surgical Site Infection, Superficial Sternal Wound Infection, Mediastinitis
- Trial name
- NCT07507409
- Testing
- Knotless Barbed Sutures, Mesh-based Topical Skin Adhesive
- Volunteers
- 401 people
- Sponsor
- Unity Health Toronto
Pain, Chest
Bilateral Pecto Intercostal Fascial Plane Block After Open Heart Surgeries
The objective is to test the effect of pecto intercostal fascial plane block (PIFB) as regard its impact on pain after sternotomy involved open heart surgery.
- Trial name
- PIFB (NCT04134637)
- Testing
- ultrasound, Bupivacaine Hydrochloride 5 MG/ML
- Where
- Egypt
- Volunteers
- 70 people
- Sponsor
- Fayoum University Hospital
Drug Resistance, Bacterial, Postoperative Wound Infection
Local Collagen-Gentamicin and Extra Fixation of the Sternum for Prevention of Sternal Wound Infection in Cardiac Surgery
The aim of the present study is to evaluate a new technique for prevention of sternal wound infection consisting of local application of collagen-gentamicin in addition to routine i.v. antibiotic prophylaxis.
- Trial name
- LOGIX (NCT00484055)
- Testing
- Local application of collagen-gentamicin, Fixation of the sternotomy with more than six wires
- Where
- 2 sites in Sweden
- Volunteers
- 1,358 people
- Sponsor
- Region Örebro County
Coronary Artery Disease, Coronary Artery Stenoses
Comparison of Sternal Wound Infiltration With Liposomal Bupivacaine v. Bupivacaine Hydrochloride
The aim of this study is to evaluate the analgesic efficacy and safety of wound infiltration with liposomal bupivacaine (LB) in patients undergoing cardiac surgery with sternotomy and cardiopulmonary bypass (CPB) and compare it…
- Conditions
- Coronary Artery Disease, Coronary Artery Stenoses, Valve Regurgitation, Mitral, Valve Regurgitation, Tricuspid
- Trial name
- NCT03270514
- Testing
- Exparel Injectable Product, Bupivacaine Hydrochloride
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Kathirvel Subramaniam
Surgical Site Infection (SSI), Mediastinitis
Use of Platelet-Rich Plasma to Reduce Sternal Wound Complications After CABG With Median Sternotomy
The goal of this clinical trial is to learn whether applying autologous platelet-rich plasma (PRP) to the sternal wound during heart surgery improves wound healing and reduces complications after surgery.
- Conditions
- Surgical Site Infection (SSI), Mediastinitis, Delayed Wound Healing
- Trial name
- NCT07352020
- Testing
- Autologous Platelet-Rich Plasma (PRP) Application, Standard Sternal Wound Closure
- Where
- Pakistan
- Volunteers
- 98 people
- Sponsor
- Shaheed Zulfiqar Ali Bhutto Medical University
Sternum Wound Infection, Nonunion of Fracture of Sternum
Sternal Closure With STERNUMFIX in Patients With High Risk
The primary objective is to establish if the SternumFix System improves sternal closure. The study should test the hypothesis that in a high risk patient population with increased risk for the development of sternal wound…
- Trial name
- STEPHIX (NCT01408745)
- Testing
- Sternumfix, steel wire
- Where
- 4 sites in Germany, Switzerland
- Volunteers
- 166 people
- Sponsor
- Aesculap AG
Surgical Site Infection, Sternal Wound Infection
Sternal Wound and Aortic Graft (SWAG), an Observational Cohort Study.
The aim of this study is to systematically explore the perioperative presence of P acnes in all layers of sternal wound incision as well as contamination of graft material and prosthetic valves during primary operation.
- Trial name
- SWAG (NCT04592328)
- Testing
- Bacterial cultures taken during surgery.
- Where
- Sweden
- Volunteers
- 50 people
- Sponsor
- Region Örebro County
Cardiac Surgical Procedures, Wound Healing
Use of the Bra as Prevention of Sternal Wound Dehiscence in Cardiac Surgery
The aim of the study was to assess the efficacy of bra application as a prevention of dehiscence in women with median sternotomy.
- Trial name
- DEHISCENCIA (NCT04290260)
- Testing
- Use of breast bra, Usual care (not use of bra)
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Germans Trias i Pujol Hospital
Cardiac Surgery, Sternal Wound Infection
Safety and Efficacy of an Antibiotic Implant in Cardiac Surgical Subjects at Higher Risk for Sternal Wound Infection
The purpose of this study is to determine whether the gentamicin-collagen sponge is safe and effective in preventing sternal wound infections in patients undergoing cardiac surgery who are at a greater risk of developing sternal…
- Trial name
- NCT00600483
- Testing
- gentamicin-collagen sponge dipped in saline
- Where
- 43 sites in United States
- Volunteers
- 1,502 people
- Sponsor
- Innocoll
Thoracic Injury, Rib Fracture
Early Aggressive Pain Management is Associated With Improved Outcomes in Blunt Thoracic Trauma
This study is designed to analyze the use of early aggressive pain management with thoracic epidural in eligible patients with blunt thoracic trauma.
- Conditions
- Thoracic Injury, Rib Fracture, Sternal Fracture
- Trial name
- Thoracic (NCT01327287)
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- University of California, San Francisco
Coronary Artery Disease, Coronary Artery Bypass Grafting
Extensive BITA Grafting in the Canary Islands: an IPTW Analysis
Coronary artery bypass grafting (CABG) remains the preferred revascularization strategy for patients with complex multivessel coronary artery disease.
- Conditions
- Coronary Artery Disease, Coronary Artery Bypass Grafting, Myocardial Revascularization
- Trial name
- BITA-SURV (NCT07796750)
- Where
- Spain
- Volunteers
- 666 people
- Sponsor
- Hospital Universitario de Gran Canaria Doctor Negrín
Mediastinitis
Infectious Mediastinitis Among the Strasbourg Universitary Hospital
Mediastinitis are rare but serious infections, with mortality rates varying from 6 to 30% according to the literature. They are essentially linked to surgical management (cardio-thoracic in particular), but some forms can be…
- Trial name
- MEDIASTINITIS (NCT05001308)
- Where
- France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Strasbourg, France
Postoperative Wound Infection Superficial Incisional, Postoperative Wound Infection Deep Incisional Surgical Site
Safety and Efficacy of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery.
This study is aimed to assess the anti-infective efficacy of D-PLEX over a period of 3 months post operation as well as the safety over a period of 6 months, by preventing sternal infection post cardiac surgery in patients above…
- Trial name
- NCT02731573
- Testing
- D-PLEX, Open heart surgery
- Where
- 5 sites in Israel
- Volunteers
- 81 people
- Sponsor
- PolyPid Ltd.
Surgical Site Infection, Sternal Infection
D-PLEX 302: Efficacy and Safety of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery
Prospective, Multinational, Multicenter, Randomized, Parallel Controlled, Two arms, Single Blind, Study to Assess the Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SOC) IV Prophylactic…
- Conditions
- Surgical Site Infection, Sternal Infection, Cardiac Surgery
- Trial name
- NCT03558984
- Testing
- D-PLEX, Standard of Care
- Where
- 3 sites in United States, Israel
- Volunteers
- 2 people
- Sponsor
- PolyPid Ltd.