Clinical trials: Surgical Wound
Scar, Surgical Scar
Pilot Study of a Novel 532nm KTP Laser for the Treatment of Fresh Surgical Scars
The purpose of this study is to evaluate the safety and efficacy of the 532nm potassium titanyl phosphate (KTP) laser in comparison with the 595nm pulsed-dye laser (PDL) for the treatment of fresh surgical scars.
- Conditions
- Scar, Surgical Scar, Cicatrix, Cicatrix, Hypertrophic
- Trial name
- NCT01789346
- Testing
- 532nm KTP, 595nm PDL
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Cutera Inc.
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
Cataract, Astigmatism
Evaluation of the Accuracy & Safety of the LaserArcs Nomogram
Evaluation of the Accuracy and Safety of the LaserArcs Femtosecond Cataract Surgery Arcuate Incision Nomogram in Patients Undergoing Cataract Surgery and Astigmatism Reduction
- Trial name
- NCT05278442
- Testing
- LaserArc
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Research Insight LLC
Linear or Emi-linear Incisions, Total Hip Arthroplasty
Prevena™ Incision Management System Over Primarily Closed Hip and Knee Incisions in Patients Immediately Post Total Hip and Knee Arthroplasty
The intent of this study is to evaluate the Prevena ™ 125 Unit and dressing system, when applied to either the hip or knee area over a surgical cut for the time you are hospitalized.
- Conditions
- Linear or Emi-linear Incisions, Total Hip Arthroplasty, Total Knee Arthroplasty
- Trial name
- Prevena2009-45 (NCT01380665)
- Testing
- Prevena Incisional Management System
- Sponsor
- KCI USA, Inc
Moderate to High-risk Noncardiac Surgery
SMART TRENDS Study
A multicenter, interventional, feasibility comparison with historical controls
- Trial name
- NCT05957406
- Testing
- Acumen HPI Smart Alerts and Smart Trends Software, The HemoSphere advanced monitoring platform with Acumen HPI software, and Acumen IQ sensor and Acumen IQ cuff
- Where
- 8 sites in United States
- Volunteers
- 296 people
- Sponsor
- Becton, Dickinson and Company
Hip Osteoarthritis, Rheumatoid Arthritis
G7 Dual Mobility With Vivacit-E or Longevity PMCF
This study is a global, multi-center, prospective, non-controlled, non-randomized, post-market clinical follow-up study. The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of…
- Conditions
- Hip Osteoarthritis, Rheumatoid Arthritis, Joint Diseases, Avascular Necrosis
- Trial name
- NCT05548972
- Testing
- G7 Dual Mobility with Vivacit-E bearing, G7 Dual Mobility Longevity bearing
- Where
- 10 sites in United States, Belgium and 2 more
- Volunteers
- 358 people
- Sponsor
- Zimmer Biomet
Abdominoplasty
Cohera TissuGlu® Surgical Adhesive in the Management of Wound Drainage
This study is designed to evaluate the safety and efficacy of the device while reducing the amount of drainage from surgical wounds following large flap surgical procedures, in this case abdominoplasty, as compared to the…
- Trial name
- NCT01526954
- Testing
- TissuGlu Surgical Adhesive
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Cohera Medical, Inc.
Post Operative Pain, Midline Sternotomy Incision
Percutaneous Electrical Nerve Stimulation (PENS) of the Auricle for Post Operative Pain Solution(POPS) - Cardiac Surgery
Percutaneous Electrical Nerve Stimulation (PENS) of the auricle for acute pain management post cardiac surgery
- Trial name
- POPS (NCT03750357)
- Testing
- Primary Relief v 2.0
- Where
- India
- Volunteers
- 60 people
- Sponsor
- DyAnsys, Inc.
Ankyloglossia
Case Series of Infants With Anterior Ankyloglossia Being Treated by the Sublingual Neonatal Incision Platform Device
A study assessing the feasibility of a novel device designed specifically to treat infant tongue-tie.
- Trial name
- SNIP (NCT07655895)
- Testing
- Frenectomy of anterior ankylogossia using the novel device
- Where
- United Kingdom
- Volunteers
- 6 people
- Sponsor
- Europa Life Sciences Limited
Aortic Aneurysm, Aortic Dissection
Thoraflex™ Hybrid IDE Study
The study will assess the effectiveness, safety and clinical outcomes of the Thoraflex™ Hybrid Device in the treatment of aortic disease affecting the aortic arch and the descending thoracic aorta, with or without involvement of…
- Conditions
- Aortic Aneurysm, Aortic Dissection, Aortic Rupture
- Trial name
- NCT02724072
- Testing
- Thoraflex™ Hybrid Device
- Where
- 12 sites in United States
- Volunteers
- 84 people
- Sponsor
- Bolton Medical
Oral Surgical Procedures, Pain
Pilot Study to Evaluate the Use of OroScience Topical Oral Wound Emulsion in Post Operative Wound Healing
The purpose of this pilot study is to determine if Topical Oral Wound Emulsion (TOWE) assists with dental wound healing and relieves pain from oral wounds.
- Trial name
- NCT00596141
- Testing
- OroScience Topical Oral Wound Emulsion
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- OroScience, Inc.
Cataract, Aphakia
Co-Axial Micro-Incision Versus Co-Axial Small Incision Cataract Surgery Using the Stellaris Enhancement System
The objective of this study is to test the hypothesis that the time to reach a stable refraction is significantly shorter in eyes operated with the 1.8 mm coaxial microincision compared to eyes operated with the 2.75 mm standard…
- Trial name
- NCT01261975
- Testing
- Coaxial Micro-Incision Cataract Surgery, Coaxial Small Incision Cataract Surgery
- Volunteers
- 36 people
- Sponsor
- Bausch & Lomb Incorporated
Wound Healing Disorder, Wounds and Injuries
Bone Bioactive Liquid Efficiency in Improving Dental Implant Osteointegration Oral Soft Tissue Hellingand Oral Surgery
The investigators implanted 264 Galaxy TS implants (with or without BBL) in 33 patients across both jaws. Implant stability and osseointegration were assessed using Initial Stability Quotient (ISQ) measurements, computed…
- Conditions
- Wound Healing Disorder, Wounds and Injuries, Wound Surgical
- Trial name
- BBLIS (NCT06371430)
- Testing
- Dental Implant insertion and tooth extraction
- Where
- Spain
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Biointelligent Technology Systems SL
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.
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
Laceration, Incision
Optilene® Suture Material for Dermal Sutures
In this non-interventional study, Optilene® suture will be evaluated for skin closure in adult patients.
- Trial name
- OPTIDERMAL (NCT05240248)
- Where
- Spain
- Volunteers
- 172 people
- Sponsor
- Aesculap AG
Bimalleolar Ankle Fractures
CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures
The OL1000 is intended to be used as a non-invasive adjunctive treatment for adult males or females that have sustained a closed, unstable ankle fracture that requires surgical treatment for stabilization.
- Trial name
- NCT02688855
- Testing
- Active Combined Magnetic Field OL1000 Bone Growth Stimulator
- Where
- 9 sites in United States
- Volunteers
- 217 people, healthy volunteers welcome
- Sponsor
- Encore Medical, L.P.
Surgical Site Infection
Irrisept Versus Standard of Care in the Prevention of Surgical Site Infections
The purpose of this study was to compare the rate of surgical site infections in patients randomized to Irrisept versus SoC, who had an open abdominal laparotomy for abdominal trauma or acute surgical abdomen.
- Trial name
- NCT02255487
- Testing
- IrriSept System, No Intervention - Standard of Care (SoC) only
- Where
- 17 sites in United States
- Volunteers
- 627 people
- Sponsor
- Irrimax Corporation
Surgical Wound
The Closer Trial: A Safety and Efficacy Study of the Rex Medical Vascular Sealing System
The objective of this trial is to demonstrate the safety and effectiveness of the Rex Medical Closer Vascular Sealing System in sealing femoral arterial access sites.
- Trial name
- Closer (NCT02136004)
- Testing
- Closer VSS
- Where
- 12 sites in United States
- Volunteers
- 220 people
- Sponsor
- Rex Medical
Pressure Injury Prevention
Evaluation of Commercially Available Heel Pads for the Prevention of Pressure Ulcers: An Observational Study of Incidence and Usability in Adult Surgical Patients.
This study will evaluate the incidence of heel pressure ulcers in adult patients undergoing elective surgery while using the Oasis Elite Heel Pad (EL130) as part of routine pressure ulcer prevention.
- Trial name
- NCT07852897
- Testing
- Oasis Elite Heel Pad (EL130)
- Where
- Ireland
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Trulife