Clinical trials: Surgical Injury
Degenerative Joint Disease, Osteoarthritis
PEAK PlasmaBlade 4.0 Versus Traditional Electrosurgery in Total Knee Replacement.
The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade 4.0 during total knee replacement; to monitor and record post-operative pain, activity level, narcotic consumption, adverse…
- Trial name
- PRECISE (NCT01081886)
- Testing
- PEAK PlasmaBlade 4.0, Traditional Electrosurgery with scalpel
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Medtronic Surgical Technologies
Pseudoarthrosis
A Clinical Trial to Assess the Effect of HC-SVT-1001 and HC-SVT-1002 in the Surgical Treatment of Atrophic Pseudarthrosis of Long Bones (Bonecure)
The purpose os this study is to evaluate the safety and effectiveness of HC-SVT-1001 and HC-SVT-1002 in the surgical treatment of atrophic nonunion in long bones.
- Trial name
- Bonecure (NCT02483364)
- Testing
- HC-SVT-1001(initial protocol); HC-SVT-1002 (protocol amendment)
- Where
- Spain
- Volunteers
- 12 people
- Sponsor
- Salvat
Tumor, Facial Fracture
A Post Market Clinical Follow-up Study on Biomet Microfixation HTR PEKK (Midface), Facial & Mandibular Plates.
This study will address medical devices manufactured by Biomet Microfixation (d.b.a. Zimmer Biomet) designed for fixation and stabilization of the facial and mandibular skeleton.
- Conditions
- Tumor, Facial Fracture, Mandibular Fractures, Fibrous Dysplasia
- Trial name
- NCT04931056
- Testing
- Titanium Facial Plates, Titanium Mandibular Plates, Add-on Condyle
- Where
- Argentina
- Volunteers
- 91 people
- Sponsor
- Zimmer Biomet
Trauma-related Wound, Surgical Incision
3M™ Topical Tissue Adhesive Versus Commercially Available Tissue Adhesive for the Closure of Lacerations and Incisions
The purpose of this study is to generate safety and performance data for 3M™ Topical Tissue Adhesive. Enrolled subjects with qualifying trauma lacerations or surgical incisions will be randomized to receive 3M™ Topical Tissue…
- Conditions
- Trauma-related Wound, Surgical Incision, Surgical Wound, Laceration
- Trial name
- Lublin (NCT06217081)
- Testing
- 3M Topical Tissue Adhesive, Histoacryl® Blue Topical Skin Adhesive
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Solventum US LLC
Acute Kidney Injury Following Cardiac Surgery
A Multi-center Study to Evaluate the Safety, Tolerability and Efficacy of TIN816 in Patients at Risk for Acute Kidney Injury Following Cardiac Surgery.
This was a randomized, multi-centric, placebo-controlled, participant and investigator-blinded study to evaluate the safety, tolerability and efficacy of TIN816 in adult patients at risk for acute kidney injury following cardiac…
- Trial name
- NCT05524051
- Testing
- TIN816
- Where
- 37 sites in United States, Argentina and 13 more
- Volunteers
- 102 people
- Sponsor
- Novartis Pharmaceuticals
Mastectomy
PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Mastectomy
The objective of this clinical study is to evaluate the incidence of partial skin necrosis following modified-radical mastectomy with or without same-day (two-stage) reconstruction with the PEAK PlasmaBlade 4.0; to monitor and…
- Trial name
- PRECISE (NCT00943605)
- Testing
- Scalpel and Traditional Electrosurgery, PEAK PlasmaBlade
- Where
- 4 sites in United States
- Volunteers
- 60 people
- Sponsor
- Medtronic Surgical Technologies
Wound Infections
Cubicin(R) for Complicated Post-surgical Wound Infections
The purpose of the study is to describe the clinical efficacy of CUBICIN therapy in patients with superficial and deep post-surgical Gram-positive wound infections
- Trial name
- PSW (NCT00651131)
- Testing
- daptomycin
- Volunteers
- 69 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Macromastia
A Study to Evaluate Cutaneous Scar Quality Following Bilateral Breast Reduction With the PEAK PlasmaBlade 4.0
The objective of this clinical study is to evaluate scar quality following incision with the PEAK PlasmaBlade 4.0 using the Patient and Observer Scar Assessment Scale (POSAS), and to compare these results to equivalently-aged…
- Trial name
- PRECISE (NCT01284491)
- Testing
- PEAK PlasmaBlade 4.0, Traditional Electrosurgery with scalpel
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Medtronic Surgical Technologies
Leg Ulcers Venous, Dehiscence, Surgical Wound
Blu Light for Ulcers Reduction
Multi-center study on the effectiveness of treatment with a blue light medical device (EmoLED) in the reduction of ulcer surface in 10 weeks.
- Trial name
- BLUR (NCT04018924)
- Testing
- Illumination with blue light (400-430nm) for 60 seconds with a power density of 120mW/sqcm (EmoLED device)
- Where
- 7 sites in Italy
- Volunteers
- 90 people
- Sponsor
- Emoled
Rotator Cuff Tear
InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear
This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear .
- Trial name
- NCT02211183
- Testing
- Best Repair of torn Rotator Cuff, InSpace™ system
- Where
- Spain
- Volunteers
- 4 people
- Sponsor
- OrthoSpace Ltd.
Surgical Wound
A Prospective, Single-arm, Clinical Trial of Electrospun Fiber Matrix (Restrata) in the Treatment of Surgical Defects Secondary to Resection of Malignant Cutaneous Neoplasms
The goal of this observational prospective study is to evaluate wound healing outcomes in resection wounds resulting from surgical removal of cutaneous malignancies treated with a synthetic electrospun fiber matrix.
- Trial name
- NCT06578650
- Testing
- Synthetic Electrospun Fiber Matrix
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Acera Surgical, Inc.
Wounds and Injuries, Hemostasis
The Hemostatic Effectiveness of "HANBIO" Gauze During Non-emergent Gynecology Surgery.
The objective of this study is to collect the hemostatic effectiveness and device safety data of "HANBIO" Gauze in subjects have acute wound result from gynecology surgery.
- Trial name
- NCT06715696
- Testing
- "HANBIO" Gauze (Sterilized, 1% Collagen)
- Where
- Taiwan
- Volunteers
- 40 people
- Sponsor
- HAN Biomedical Inc
Hypertrophic
Investigation of a Novel Silicone Dressing to Maximize the Outcomes of Scar Revision Procedures (IMPROVE)
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
- IMPROVE (NCT01430130)
- Testing
- embrace device
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Neodyne Biosciences, Inc.
Wound Healing, Scarring
The Effects of Topical Calcium Glycerophosphate on Surgical Wound Healing and Residual Scarring
The purpose of this study is to determine whether topical application of calcium glycerophosphate will result in superior wound appearance and scar minimization.
- Trial name
- TOPCGP-2008 (NCT01264588)
- Testing
- Topical calcium glycerophosphate lotion
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- AkPharma Inc.
Surgical Wound, Recent, Surgical Wound Leak
Study of Avelle™ Negative Pressure Wound Therapy (NPWT) System
The main questions the study aims to answer are: How much do wounds improve when using the Avelle™ Negative Pressure Wound Therapy System for a maximum of 14 days? How safe is the Avelle™ Negative Pressure Wound Therapy System?
- Conditions
- Surgical Wound, Recent, Surgical Wound Leak, Dehiscence Wound, Trauma-related Wound
- Trial name
- NCT05805046
- Testing
- Negative Pressure Wound Therapy System
- Where
- 4 sites in United States
- Sponsor
- ConvaTec Inc.
Surgical Wound Infection
Multicenter Infection Surveillance Study Following Colorectal Procedures
This study is a multicenter, open label, observational, postmarketing surveillance study of the ON-Q® Silver SoakerTM in the United States and Canada.
- Trial name
- MISS (NCT00762060)
- Testing
- ON-Q Silver soaker System, Patient controlled analgesia
- Volunteers
- 289 people
- Sponsor
- Halyard Health
Coronary Artery Bypass Surgery
Reduction of Ischemia-Reperfusion Mediated Cardiac Injury in Subjects Undergoing Coronary Artery Bypass Graft Surgery
This clinical trial will investigate the safety and effectiveness of IK-1001 (the liquid form of sodium sulfide) when used in Coronary Artery Bypass Graft (CABG) patients to potentially reduce the damage done to the heart during…
- Trial name
- NCT00858936
- Testing
- IK-1001, Normal Saline
- Where
- 8 sites in Australia, Canada
- Volunteers
- 6 people
- Sponsor
- Mallinckrodt
Surgical Incisions
Prineo (Dermabond Protape) Versus Sutures for Full-thickness Surgical Incisions
This is a prospective, controlled, randomized, multi-center clinical study of up to 80 subjects with full thickness surgical incisions.
- Trial name
- NCT00557947
- Testing
- Suture, Dermabond Protape (Prineo)
- Where
- 5 sites in Belgium, Germany and 2 more
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Ethicon, Inc.
Ischemia Reperfusion Injury, Cardiac Surgery Associated - Acute Kidney Injury
A Study to Evaluate the Efficacy and Safety of BX-001N in Preventing Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI) and Major Adverse Kidney Events (MAKE)
This is a Randomized, Single-blind, Multi-center, Placebo-controlled, Phase 2a clinical trial of BX-001N to prevent patients from Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI) and subsequent Major Adverse Kidney Events…
- Trial name
- NCT07164833
- Testing
- BX-001N Experimental group 1, BX-001N Experimental group 2
- Where
- 8 sites in South Korea
- Volunteers
- 50 people
- Sponsor
- Bilix Co.,Ltd.
Homonymous Hemianopsia, Homonymous Quadrantanopia
PAVE (Parallactic Visual-Field Enhancement) System for Treatment of Chronic Visual Field Loss Due to Stroke, Traumatic Brain Injury, or Brain Surgery
This is a research study to evaluate the effectiveness of the PAVE (Parallactic Visual-Field Enhancement) System for the treatment of chronic visual field loss due to stroke, traumatic brain injury, or brain surgery.
- Trial name
- NCT07185971
- Testing
- PAVE (Parallactic Visual-Field Enhancement) treatment using a virtual reality head mounted display
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- NeuroAEye LLC