Clinical trials: Sternotomy Wound
Surgical Wound Infection
Effects of a New Antimicrobial Dressing on Wound Healing and Incidence of Sternal Wound Infections
The primary objective of this pivotal study is to determine if a new antimicrobial dressing, applied to the sternal incisions of cardiac surgical subjects, will demonstrate a decreased cumulative incidence rate(CI) of localized…
- Trial name
- NCT00203541
- Testing
- TELFA™ A.M.D. Island dressing
- Where
- United States
- Volunteers
- 1,100 people
- Sponsor
- Tyco Healthcare Group
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
Wound Infection
Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections
The purpose of this study is to show that the incidence of sternal wound infections at day 30 after cardiac surgery is 50% lower with the additional use of Daptomycin on top of a standard antibiotic prophylaxis as compared to the…
- Trial name
- DaPro (NCT01080963)
- Testing
- Daptomycin, Cefuroxime
- Where
- Germany
- Volunteers
- 650 people
- Sponsor
- Hannover Medical School
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
Pain, Postoperative, Surgical Wound
Transversus Thoracis Muscle Plane Block for Sternotomy Pain in Cardiac Surgery
Sternotomy pain is usually significant after cardiac surgery. Analgesic options for sternotomy in cardiac surgery are often limited. Poorly controlled acute pain is an important factor to development of chronic postsurgical pain.
- Conditions
- Pain, Postoperative, Surgical Wound, Cardiac Event
- Trial name
- NCT04596163
- Testing
- Transversus thoracis muscle plane block
- Where
- Hong Kong
- Volunteers
- 86 people
- Sponsor
- Chinese University of Hong Kong
Surgical Site Infection; Cardiac Surgery; Advanced Dressing; Postoperative Care
Does Occlusive Hydrocolloid Silver-containing Wound Dressing After Sternotomy Reduce Surgical Side Infection After Cardiac Surgery?
Wound healing disorders are a major problem in cardiac surgery. They prolong the inpatient stay and are associated with a high health and, above all, psychological burden for patients.
- Trial name
- OHSCWD (NCT06508879)
- Testing
- Aquacel Ag Surgical®, Standard Care (sterile gauze and adhesive tape)
- Where
- Germany
- Volunteers
- 352 people
- Sponsor
- University Medical Center Mainz
Diseases of Mitral Valve, Aortic Valve Disorder
Comparison of the Local Anaesthetics Articaine and Bupivacaine in Treatment of Acute Sternum Pain After Heart Surgery
The purpose of this study is to examine the wound infusion of articaine for treatment of acute post-sternotomy pain in a placebo-controlled manner using a prospective and randomized design and an active control (bupivacaine)
- Conditions
- Diseases of Mitral Valve, Aortic Valve Disorder, Atrial Septal Defects, Intracardiac Myxoma
- Trial name
- NCT01536717
- Testing
- Articaine hydrochloride 2% solution, Sodium Chloride
- Where
- 2 sites in Finland
- Volunteers
- 36 people
- Sponsor
- Helsinki University Central Hospital
Surgical Site Occurences After Sternotomy, Wound Infection
The Use of PrevenaTM on Clean Closed Sternal Midline Incisions in Subjects at High Risk for Surgical Site Occurrences.
The purpose of this study is to compare the use of Prevena™ Incision Management System (IMS) versus standard wound care for the incision in subjects undergoing a sternal midline incision (sternotomy).
- Trial name
- NCT02195310
- Testing
- Prevena™ Incision Management System, Conventional sterile wound dressings
- Where
- 13 sites in Austria, Germany and 1 more
- Volunteers
- 342 people
- Sponsor
- Solventum US LLC
Trauma Chest
Median Sternotomy in Penetrating Cardiac Trauma
The investigators aim to assess role of median sternotomy in penetrating cardiac trauma regarding morbidity and mortality of the patients.
- Trial name
- NCT04917198
- Testing
- median sternotomy
- Volunteers
- 100 people
- Sponsor
- Assiut University
Scar
Early Postoperative Prevention and Treatment of Median Sternotomy Scars With Botulinum Toxin Type A Injection
Linear hypertrophic scar is a common surgical problem that can be difficult to manage, especially for the median sternotomy scar.
- Trial name
- NCT02886988
- Testing
- Botulinum toxin type A, normal saline
- Where
- China
- Volunteers
- 17 people
- Sponsor
- Xijing Hospital
Surgical Wound Infection
Effects of Showering in 48-72 Hours of Median Sternotomy on Wound Infection, Pain, Comfort and Satisfaction
Time of showering after surgery is still a controversial issue for surgical patients and health professionals. It has been reported that patients should not shower until sutures are removed since traditionally showering is…
- Trial name
- NCT04250961
- Testing
- postoperative early shower
- Where
- Turkey (Türkiye)
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Pamukkale University
Pain, Postoperative, Cardiac Surgery
Chest Wall Block After Sternotomy: Randomized Controlled Trial in Cardiac Surgery: (PABLOS Study)
The main objective is to compare the effectiveness of LocoRegional Anesthesia (LRA) (bilateral transverse thoracic block or bilateral parasternal block) in addition to standard management compared to standard management alone…
- Trial name
- PABLOS (NCT05345639)
- Testing
- LRA Loco-regional anesthesia, Standardized post-operative analgesia protocol
- Where
- France
- Volunteers
- 254 people
- Sponsor
- University Hospital, Angers
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.
Postoperative Pain, Cardiac Surgery
Parasternal Block Versus Wound Infiltration for Pain After Median Sternotomy:A Salivary Opiorphin-Based Study
This study evaluated the effects of parasternal block and wound site infiltration on postoperative pain in patients undergoing median sternotomy.
- Conditions
- Postoperative Pain, Cardiac Surgery, Median Sternotomy
- Trial name
- NCT07621744
- Testing
- Parasternal blocks, Wound Site Infiltration
- Where
- Turkey (Türkiye)
- Volunteers
- 120 people
- Sponsor
- Ataturk University
Pain, Postoperative, Coronary Artery Disease
Pecto-Intercostal Fascial Block vs. Transversus Thoracic Muscle Plane Block in Cardiac Surgery
In patients undergoing open cardiac surgery, pain control is an essential part of the enhanced recovery process. The current study aimed to evaluate the analgesic efficacies of ultrasound-guided pecto-intercostal fascial block…
- Trial name
- NCT04791592
- Testing
- Single-injection, ultrasound-guided bilateral PIF block., Single-injection, ultrasound-guided bilateral TTMP block.
- Where
- Turkey (Türkiye)
- Volunteers
- 42 people
- Sponsor
- Ondokuz Mayıs University
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
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
Sternotomy Wound
Wound Inflammatory Cells After Cardiac Surgery
One hundred patients, aged from 41 to 78 years, underwent open heart surgery in the years 1998-1999 and were studied by using the Cellstick device for harvesting wound inflammatory cells during the first 24 hours after surgery.
- Trial name
- NCT02875509
- Volunteers
- 100 people
- Sponsor
- Turku University Hospital
Heart Surgery Via Sternotomy, Post-operative Analgesia
Advantage of Tramadol in Local Analgesia Post-Sternotomy
Sternotomy, the reference approach for heart surgery, may induce profound and intense post-operative pain. One method of analgesia used is patient-controlled intravenous morphine.
- Trial name
- ATLAS (NCT02851394)
- Testing
- Levobupivacaine, tramadol
- Where
- France
- Volunteers
- 160 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
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