Clinical trials: Surgical Care
Surgical Site Infections
Safety, Efficacy and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal Surgery
This is a randomized, blinded, placebo and standard of care controlled study of the efficacy of a novel antibiotic containing gel compared to placebo gel in preventing surgical site infection after abdominal surgery.
- Trial name
- NCT01888367
- Testing
- DFA-02 Antibiotic Gel
- Where
- 31 sites in United States
- Volunteers
- 445 people
- Sponsor
- Dr. Reddy's Laboratories Limited
Diabetic Foot Osteomyelitis
A Feasibility Trial to Investigate the Safety and Between-group Effect Size of STIMULAN VG and Standard of Care (SoC) in Participants With Diabetic Foot Osteomyelitis
The purpose of this trial is to evaluate the safety and between-group effect size of STIMULAN VG compared to SoC treatment in patients with diabetic foot osteomyelitis (DFO).
- Trial name
- BLADE-VG2 (NCT05539963)
- Testing
- STIMULAN VG, Systemic Antibiotics
- Where
- 10 sites in United States
- Volunteers
- 61 people
- Sponsor
- Biocomposites Ltd
Pain, Postoperative
An Efficacy and Safety Study to Compare Fentanyl Ionsys and Routine Care With Intravenous (IV) Morphine Patient-controlled Analgesia (PCA) in Participants Who Have Undergone Elective Major Abdominal or Orthopedic Surgery
The purpose of this study is to evaluate the mobilization characteristics, clinical use, safety and Ease of Care (EOC) of a fentanyl Iontophoretic Transdermal Patient Controlled Analgesia (PCA) system (Ionsys) and morphine…
- Trial name
- NCT00766506
- Testing
- Fentanyl IONSYS, Morphine IV PCA
- Where
- 7 sites in United Kingdom
- Volunteers
- 108 people
- Sponsor
- Janssen-Cilag Ltd.
Hemostasis, Meningioma Surgery
Phase IV Bioseal Study in Brain Tumor Surgery
The objective of this study is to observe the clinical utility and performance of Bioseal when used as an adjunct to hemostasis versus Standard of Care (SoC) in elective meningioma surgery.
- Trial name
- NCT02034799
- Testing
- Bioseal Fibrin Sealant, Standard of Care (SoC)
- Where
- 7 sites in China
- Volunteers
- 256 people
- Sponsor
- Ethicon, Inc.
Chronic Wounds, Venous Leg Ulcers (VLUs)
Efficacy of Carbonlife Amniotic Tissue Product in the Treatment of Chronic Wounds
Chronic wounds constitute a significant global health burden, affecting millions of individuals and contributing to increased morbidity, diminished quality of life, and rising healthcare costs.
- Conditions
- Chronic Wounds, Venous Leg Ulcers (VLUs), Diabetic Foot Ulcers (DFUs), Arterial Ulcers
- Trial name
- NCT07223892
- Testing
- Amniotic Tissue Allograft
- Volunteers
- 600 people
- Sponsor
- Bardia Anvar
Greater Trochanteric Pain Syndrome, Hip Pain Chronic
Research Study to Compare the Addition of Topaz Micro Debridement to the Standard of Care Surgery
Compare the surgical use of Topaz with the Standard Of Care in the treatment of Greater Trochanteric Pain Syndrome (a type of hip pain). The hypothesis is that there is a difference between the two treatment groups.
- Trial name
- NCT01562366
- Testing
- Topaz, Iliotibial band release and trochanteric bursectomy
- Where
- Australia
- Volunteers
- 66 people
- Sponsor
- Smith & Nephew, Inc.
Venus Leg Ulcers
Controlled Study, Performed to Evaluate the Safety and Efficacy of EscharEx and Its Placebo (Gel Vehicle) Compared to Non-surgical Standard of Care in Participants With Venous Leg Ulcers (VLU)
The objectives of this study are: To evaluate the safety of EscharEx and its placebo Gel Vehicle compared to non-surgical standard of care (NSSOC) To assess the efficacy of EscharEx (EX-03 5% formulation) compared to placebo…
- Trial name
- H2H (NCT06690177)
- Testing
- EscharEx (EX-03), Non-surgical standard of care (NSSOC)
- Where
- 2 sites in United States, Poland
- Volunteers
- 45 people
- Sponsor
- MediWound Ltd
Chronic Otitis Media
Retrospective Health Care Utilisation and Current Quality of Life in Adults With Chronic Otitis Media Who Had a Middle Ear Surgery
The objective of this multicentre study is to evaluate the standard of care of participants diagnosed with Chronic Otitis Media that have already gone through a first middle ear surgery but still have at least a moderate hearing…
- Trial name
- NCT04864912
- Testing
- Questionnaires and survey
- Where
- 6 sites in France, Germany and 1 more
- Volunteers
- 69 people
- Sponsor
- Cochlear
Obesity, Morbid Obesity
Effects of a Novel Dietary Intervention on Body Composition After Laparoscopic Gastric Bypass Surgery
We propose to compare the standard of care with the use of a novel medical food in 6 bariatric surgery patients by measuring outcomes of body composition, quality of life, hair loss, muscle strength, resting energy expenditure…
- Trial name
- NCT01041261
- Testing
- BariatrX Essentials 360 Treatment
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- MetaProteomics LLC
Blood Glucose
Clinical Study of the Intravenous Blood Glucose System in Hospitalized Adult Elective or Non-Emergent Surgery and Medical/Surgical Intensive Care Unit Patients
The primary objective of this study is to evaluate the performance and safety of the intravenous blood glucose (IVBG) System relative to point of care (POC) meter performance when each method is compared to the Yellow Springs…
- Trial name
- NCT00906490
- Testing
- Intravenous Blood Glucose monitoring system
- Where
- 5 sites in United States
- Volunteers
- 100 people
- Sponsor
- Edwards Lifesciences
Pressure Ulcer, Stage IV, Osteomyelitis
A Randomized Controlled Phase II Trial of STIMULAN VG vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers.
The purpose of this trial is to assess the safety, tolerability and between-group effect size of STIMULAN VG (with debridement) and a course of systemic antibiotics to standard of care (debridement and systemic antibiotics only)…
- Trial name
- BLADE OPU2 (NCT06283979)
- Testing
- STIMULAN VG, Standard of Care
- Where
- 9 sites in United States
- Volunteers
- 60 people
- Sponsor
- Biocomposites Ltd
Peripheral Nerve Injury Upper Limb, Peripheral Nerve Injury (PNI)
This Study Will Evaluate the Effectiveness of NTX-001, a Surgical Nerve Repair Product When Used in People With Upper Extremity Nerve Lacerations.
NTX-001 is a single use surgical product intended for use in conjunction with standard suture neurorrhaphy of severed nerves in patients between 18 and 80.
- Trial name
- NCT06616025
- Testing
- NTX-001 (PEG-Fusion)
- Where
- 25 sites in United States
- Volunteers
- 98 people
- Sponsor
- Neuraptive Therapeutics Inc.
Hemorrhage
The EVARREST® Fibrin Sealant Patch Liver Study
To evaluate the safety and hemostatic effectiveness of EVARREST® Fibrin Sealant Patch (EVARREST) versus standard of care treatment (SoC) in controlling parenchymal bleeding during hepatic surgery.
- Trial name
- NCT01993888
- Testing
- EVARREST® Fibrin Sealant Patch, Standard of Care (SoC)
- Where
- 17 sites in United States, Australia and 2 more
- Volunteers
- 102 people
- Sponsor
- Ethicon, Inc.
Sedation
Clinical Study to Investigate the Efficacy and the Safety of DA-9501 in Sedation During the Surgery or Medical Procedure Without Intubation
The purpose of this study is to evaluate the efficacy and the safety of DA-9501 (Dexmedetomidine) in sedation during the surgery or medical procedure without intubation under monitored sedation care.
- Trial name
- NCT01438931
- Testing
- DA-9501
- Where
- 18 sites in Japan
- Volunteers
- 162 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Post-operation Pain
A Feasibility Dose-escalating Study of MDT-10013 for Acute Postoperative Pain Following Total Knee Arthroplasty
This is an open-label dose-escalating study to evaluate the tolerability and systemic exposure of MDT-10013 in men and women at least 18 years of age who are undergoing primary unilateral TKA.
- Trial name
- NCT02263222
- Testing
- MDT-10013
- Where
- 3 sites in United States
- Sponsor
- Medtronic Spinal and Biologics
Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs)
Study of Miro3D Wound Matrix for Healing Wounds and Ulcers in Outpatient Care
This clinical study is being conducted to evaluate how well the Miro3D Wound Matrix helps heal difficult wounds and ulcerations in an outpatient care setting.
- Conditions
- Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs), Pressure Ulcers, Surgical Wound Dehiscence (SWD)
- Trial name
- NCT06939673
- Testing
- Acellular Porcine-Derived Wound Matrix
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Reprise Biomedical, Inc.
Neuromuscular Blockade, Arthroplasty, Replacement, Hip
Reversal of Neuromuscular Blockade With Sugammadex or Usual Care in Hip Fracture Surgery or Joint (Hip/Knee) Replacement (P07038)
This study will assess the effect of reversal of neuromuscular blockade with sugammadex compared with reversal according to usual care (neostigmine or spontaneous reversal) on the incidence of post-surgical bleeding events and on…
- Conditions
- Neuromuscular Blockade, Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Blood Coagulation
- Trial name
- NCT01422304
- Testing
- Sugammadex, neostigmine and glycopyrrolate or atropine
- Volunteers
- 1,198 people
- Sponsor
- Merck Sharp & Dohme LLC
Analgesia
Pharmacoeconomic Consequences Of Analgesia in the Intensive Care Unit (ICU)
This study will be a multicentre randomized, open-label, phase IIIb study. This study will evaluate two different techniques of sedation: an analgesia based regimen with remifentanil versus a conventional sedation based regimen…
- Trial name
- NCT00436345
- Testing
- Remifentanil, Propofol
- Where
- 6 sites in Italy
- Volunteers
- 39 people
- Sponsor
- GlaxoSmithKline
Surgical Wound, Surgical Site Infection
Clinical Assessment of Next Science Wound Gels in Healing Below the Knee Amputation Surgical Wound Compared to SOC
This is a 64-patient, 90-day, open -label study on adult patients undergoing below knee amputation for various etiologies. The objective of this study is to assess surgical wound healing and wound bioburden using combination…
- Conditions
- Surgical Wound, Surgical Site Infection, Surgical Wound Infection, Amputation Stump; Infection
- Trial name
- NCT04053946
- Testing
- Next Science Wounds Gels
- Sponsor
- Next Science TM
Post Cardiac Surgery
Evaluation of EarlySense Home Care Tele-monitoring Device -For Early Detection of Deterioration For Cardiac Patients at Home
The aim of this study is to evaluate the relevance of the information as provided by the EarlySense Home care Tele-monitoring system can provide relevant flagging information for clinicians to identify the patients at higher risk…
- Trial name
- NCT02659982
- Where
- Israel
- Volunteers
- 50 people
- Sponsor
- EarlySense Ltd.