Clinical trials: Surgical Injury
Surgical Wound
AMBULATE Continued Access Protocol to Evaluate the Cardiva Mid-Bore Venous Vascular Closure System (VVCS)
The objective of the trial is to demonstrate the safety and effectiveness of the Cardiva Mid-Bore Venous Vascular Closure System (VVCS) in sealing femoral venous access sites at the completion of catheter-based procedures…
- Trial name
- NCT03573206
- Testing
- Cardiva Mid-Bore Venous Vascular Closure Device (VVCS)
- Where
- 3 sites in United States
- Volunteers
- 168 people
- Sponsor
- Cardiva Medical, Inc.
Incisional Hernia
Xen Matrix™ AB Surgical Graft in Ventral or Incisional Midline Hernias
This study aims to prospectively explore the use of XenMatrix™ AB Surgical Graft for ventral or incisional midline hernia repair in patients across all wound classes ("All Comers") through 24 months post repair.
- Trial name
- NCT02691962
- Testing
- Xen Matrix AB
- Where
- 11 sites in United States
- Volunteers
- 75 people
- Sponsor
- C. R. Bard
Breast Cancer
PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Lumpectomy
The purpose of this clinical study is to quantify the difference in thermal injury depth at the surgical margin in breast lumpectomy specimens excised with the PlasmaBlade; to subjectively assess histopathologic sample quality…
- Trial name
- PRECISE (NCT00960154)
- Testing
- PEAK PlasmaBlade, Traditional Electrosurgery with scalpel
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Medtronic Surgical Technologies
Neuralgia
P4 (Pregabalin for Peripheral Posttraumatic Pain)
To evaluate the efficacy of pregabalin compared to placebo in the treatment of posttraumatic peripheral neuropathic pain
- Trial name
- P4 (NCT00292188)
- Testing
- pregabalin
- Where
- 44 sites in Belgium, Canada and 9 more
- Volunteers
- 255 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Cerebrospinal Fluid Leak
Efficacy and Safety of FS VH S/D 500 S-apr (Tisseel) as an Adjunct to Sutured Dural Repair in Cranial Surgery
The objective of this study is to evaluate the safety and efficacy of FS VH S/D 500 s-apr for use as an adjunct to sutured dural repair in cranial surgery.
- Trial name
- NCT02891070
- Testing
- FS VH S/D 500 s-apr, DuraSeal Dural Sealant
- Where
- 25 sites in United States, Czechia and 2 more
- Volunteers
- 224 people
- Sponsor
- Baxter Healthcare Corporation
Femoral Fractures
Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Surgery For Long Bone Fracture
Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in a number of types of surgery.
- Trial name
- NCT00824564
- Testing
- Tranexamic Acid plus standard of care, Standard of care
- Where
- India
- Volunteers
- 82 people
- Sponsor
- Pfizer
Wound Contamination, Colorectal Surgery
Cleancision IntRaoperative Contamination prEvention Study
This study entitled, An Evaluation of the Safety and Efficacy of the CleanCision Wound Retraction and Protection System in Protecting Surgical Incisions from Intraoperative Contamination When Used during Colorectal Surgery, is…
- Trial name
- CIRCE (NCT02413879)
- Testing
- CleanCision
- Where
- 7 sites in United States
- Volunteers
- 108 people
- Sponsor
- Prescient Surgical
Elastosis
PEAK PlasmaBlade™ vs. Traditional Electrosurgery in Abdominoplasty
The objective of this clinical study is to evaluate healing of incisions made with the PEAK PlasmaBlade 4.0 compared to scalpel and traditional electrosurgery (Bovie); to monitor and record key post-operative metrics following…
- Trial name
- PRECISE (NCT00943150)
- Testing
- PEAK PlasmaBlade, Standard of Care (SOC)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Medtronic Surgical Technologies
Arthroscopic Surgical Treatment of High-grade (>50%) Partialthickness
Treatment of Partial-Thickness Rotator Cuff Tears
The goal of this clinical trial is to demonstrate that REGENETEN is superior to standard repair techniques when surgically treating high-grade (>50%) partial-thickness tears.
- Trial name
- REGEN PUB 2018 (NCT03734536)
- Testing
- REGENETEN™ Bioinductive Implant, Arthroscopic repair of the high-grade (>50%) partial-thickness
- Where
- 10 sites in United States
- Volunteers
- 168 people
- Sponsor
- Smith & Nephew, Inc.
Surgical Site Infection, Colon Surgery
D-PLEX 311: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection
Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to assess Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SoC), compared to a SoC treated…
- Conditions
- Surgical Site Infection, Colon Surgery, Abdominal Surgery, Post-Op Infection
- Trial name
- NCT04233424
- Testing
- D-PLEX, Standard of Care (SoC)
- Where
- 62 sites in United States, Bulgaria and 8 more
- Volunteers
- 977 people
- Sponsor
- PolyPid Ltd.
Abscess, Wound Infection
Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
The primary object is to compare the early clinical efficacy (after 48-72 hours of therapy) of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral linezolid) for the treatment of patients with a…
- Conditions
- Abscess, Wound Infection, Surgical Site Infection, Cellulitis
- Trial name
- NCT01431339
- Testing
- IV Dalbavancin, Vancomycin/Linezolid
- Where
- 137 sites in United States, Bulgaria and 12 more
- Volunteers
- 739 people
- Sponsor
- Durata Therapeutics Inc., an affiliate of Allergan plc
Hypertrophic
A Study of a Novel Silicone Dressing to Minimize Scar Formation
Neodyne has developed an investigational dressing for post-operative incision care. Neodyne is conducting this research to study whether the investigational dressing, called the Neodyne Dressing, can minimize scar formation in a…
- Trial name
- REFINE (NCT01399099)
- Testing
- embrace device
- Where
- 13 sites in United States
- Volunteers
- 67 people
- Sponsor
- Neodyne Biosciences, Inc.
Trauma-related Wound, Surgical Wound, Recent
Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System for Treatment of Acute Trauma and Acute Surgical Excision Wounds
The purpose of this study is to evaluate the efficacy of the Spiracur SNaP® Wound Care System for the treatment of acute trauma and acute surgical excision wounds.
- Trial name
- NCT01417234
- Testing
- SNaP® Wound Care System
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- 3M
Intraoperative Ureter Visualization, Abdominolpelvic Surgery
A Study to Find Out if ASP5354 Can Clearly Help Show the Ureter During Surgery
The ureter was the tube that carries urine from the kidneys to the bladder. It was difficult for surgeons to see the ureter during abdominal surgery. This could lead to injuring the ureter which, although rare, could be serious.
- Trial name
- NCT05754333
- Testing
- pudexacianinium chloride
- Where
- 6 sites in United States
- Volunteers
- 107 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Surgical Site Infection
Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections
The purpose of this study is to assess the efficacy and safety of delafloxacin administered as IV and oral formulation in comparison with Best Available Therapy (BAT) in patients with superficial or deep incisional surgical site…
- Trial name
- DRESS (NCT04042077)
- Testing
- Delafloxacin, Vancomycin, Linezolid
- Where
- Italy
- Volunteers
- 268 people
- Sponsor
- Menarini Group
Full-thickness Skin Defects, Degloving Injuries
RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction
A prospective randomized within-subject controlled study to compare the clinical performance of conventional autografting with and without the RECELL system on acute non-burn full-thickness skin defects.
- Conditions
- Full-thickness Skin Defects, Degloving Injuries, Crush Injuries, Laceration of Skin
- Trial name
- NCT04091672
- Testing
- Control Intervention (Conventional Autograft), Investigational Intervention (RECELL + more widely meshed autograft)
- Where
- 18 sites in United States
- Volunteers
- 65 people
- Sponsor
- Avita Medical
Bacterial Infections
Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.
- Trial name
- NCT00423657
- Testing
- ceftaroline, vancomycin plus aztreonam
- Where
- 54 sites in United States, Argentina and 10 more
- Volunteers
- 680 people
- Sponsor
- Forest Laboratories
Bone Metastases
A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects.
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone metastases in subjects with advanced breast cancer.
- Trial name
- NCT00321464
- Testing
- Denosumab, Zoledronic Acid
- Volunteers
- 2,049 people
- Sponsor
- Amgen
Acute Kidney Injury
Efficacy and Safety of RMC-035 in Subjects at High Risk for Acute Kidney Injury Following Open-Chest Cardiac Surgery
This study evaluates RMC-035 compared to placebo for the prevention of acute kidney injury (AKI) in subjects who are at high risk for AKI following cardiac surgery.
- Trial name
- AKITA (NCT05126303)
- Testing
- RMC-035
- Where
- 29 sites in United States, Canada and 3 more
- Volunteers
- 177 people
- Sponsor
- Guard Therapeutics AB
Sternal Wound Infection, Sternal Non-union
Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain
The goal of this study is to evaluate sternal osteosynthesis, chest wall pain and return to normal activity in open heart surgery patients who had their breast bone closed either with wires or plates.
- Conditions
- Sternal Wound Infection, Sternal Non-union, Pain, Mediastinitis
- Trial name
- RESTORE (NCT00819286)
- Testing
- SternaLock Rigid Fixation Plates, wire (control)
- Where
- 6 sites in United States, Germany
- Volunteers
- 140 people
- Sponsor
- Zimmer Biomet