Clinical trials: Incisions, Surgical
Surgical Wound Infection, Traumatic Wound Infection
A Study of Amicidin-β Topical Solution for Patients With a Contaminated or Infected Surgical or Traumatic Wound or Cutaneous Abscess
The goal of this Phase 1 clinical trial is to learn about the safety profile of Amicidin-β topical solution applied directly into contaminated or infected surgical or traumatic wounds or cutaneous abscess during a surgical…
- Conditions
- Surgical Wound Infection, Traumatic Wound Infection, Cutaneous Abscess
- Trial name
- NCT07379684
- Testing
- Amicidin-β topical solution - 15 mL, Amicidin-β topical solution - 50 mL, Standard of Care (SOC)
- Where
- 5 sites in United States
- Volunteers
- 44 people
- Sponsor
- Macro Biologics, Inc.
Cataract
Corneal Incisions With the IntraLase iFS Femtosecond Laser System
The IntraLase iFS femtosecond laser system can create corneal arcuate incisions for cataract surgery.
- Trial name
- NCT01713660
- Testing
- iFS Femtosecond Laser
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Abbott Medical Optics
Laparotomy, Suture; Complications, Mechanical
DuraMesh Laparotomy Study
This is a multisite randomized control proof-of-concept trial to evaluate the safety of Duramesh laparotomy closure in the trauma and emergency laparotomy setting.
- Conditions
- Laparotomy, Suture; Complications, Mechanical, Hernia Incisional
- Trial name
- NCT03966768
- Testing
- Duramesh suturable mesh for laparotomy closure, Conventional suture for laparotomy closure
- Sponsor
- Mesh Suture Inc.
Surgical Incision
The REBUILD Trial: Closure of the Abdominal Wall
The main objective of this clinical trial is to demonstrate the safety and efficacy of REBUILD when used to support abdominal wall closure after laparotomy.
- Trial name
- NCT05687942
- Testing
- REBUILD
- Where
- Israel
- Volunteers
- 40 people
- Sponsor
- AbSolutions Med Inc.
Surgical Wound, Bilateral Total Knee Arthroplasty
Evaluating Edema and Range of Motion Using Negative Pressure Therapy vs. Standard Surgical Dressing in Bilateral TKA
This study will compare the effects of closed incision negative pressure dressing vs. standard of care silver dressing on lower limb swelling after bilateral primary total knee arthroplasty.
- Conditions
- Surgical Wound, Bilateral Total Knee Arthroplasty, Wounds and Injuries, Joint Diseases
- Trial name
- ENABLE (NCT04712019)
- Testing
- Closed Incision Negative Pressure Therapy (ciNPT), Standard Silver-containing Dressing
- Where
- 6 sites in United States
- Volunteers
- 10 people
- Sponsor
- Solventum US LLC
Post-surgical Wounds
Evaluation of the Safety and Efficacy of FBPM10 System in the Treatment of Post-surgical Wounds
This is a prospective randomized controlled case series in patients having a surgery for bilateral breast reduction. Objectives of the case series are to evaluate the safety and efficacy of the FBPM10 System when compared with…
- Trial name
- NCT03271164
- Testing
- FBPM10 System, Massages with vitamin E cream
- Where
- Canada
- Volunteers
- 5 people
- Sponsor
- KLOX Technologies 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.
Dural Defect, Cerebrospinal Fluid Leak
Immiseal™ Dural Sealant Post-Market Registry Study
This is a multicentre, prospective, open-label, single-arm, observational, post-market clinical follow-up registry study designed to observe the safety and performance of the Immiseal™ Dural Sealant System when used as an adjunct…
- Conditions
- Dural Defect, Cerebrospinal Fluid Leak, Neurosurgical Procedures
- Trial name
- NCT07651826
- Where
- Latvia
- Volunteers
- 85 people
- Sponsor
- Medprin Regenerative Medical Technologies Co., Ltd.
Surgical Wound
A Comparative Efficacy and Safety Study Between Two Silver Containing Dressings In Post-Op Wound Healing
Study objective: The objective of this study is to evaluate through clinical criteria the clinical efficacy and safety of BCT Silver Bandage role in obstetrical and gynecological wound healing is as effective and safe as Aquacel®…
- Trial name
- NCT01605968
- Testing
- BCT Silver Bandage, Aquacel® Ag. Dressing
- Where
- Taiwan
- Volunteers
- 38 people
- Sponsor
- Bio-medical Carbon Technology Co., Ltd.
Wounds and Injuries
Comparison of Surgical Incision Complications in Patients Receiving PICO or Standard Care Following Colorectal Surgery
Surgical Site Complications (SSC's) are responsible for increased morbidity in patients undergoing surgery resulting in prolonged length of stay in the hospital while increasing treatment and hospital costs dramatically.
- Trial name
- NCT02883010
- Testing
- PICO Softport V1.6, Standard Care
- Sponsor
- Smith & Nephew, Inc.
Surgical Wound
Clinical Evaluation of a Novel Incisional NPWT System
A study of the first clinical use in humans of a novel NPWT system (npSIMS) to assess the suitability, safety and efficacy of the system for the management of closed surgical wounds
- Trial name
- NCT04488666
- Testing
- npSIMS
- Where
- New Zealand
- Volunteers
- 23 people
- Sponsor
- Aatru Medical LLC
Post-operative Complications, Surgical Site Infection
The Use of the Prevena™ Incision Management System on Post-Surgical Cesarean Section Incisions
The purpose of this study is to compare the post-surgical standard-of-care dressing to the Prevena™ Incision Management System in women undergoing Cesarean section surgery.
- Conditions
- Post-operative Complications, Surgical Site Infection, Surgical Wound Infection
- Trial name
- NCT01450631
- Testing
- Prevena™ Incision Management System (PIMS), Standard-of-care Dressing
- Where
- United States
- Volunteers
- 92 people
- Sponsor
- KCI USA, Inc
Cataract, Astigmatism
Astigmatism Correction With Intrastromal Arcuate Incisions in Eyes Undergoing Cataract Surgery With Femtosecond Laser Using the Cassini Ambient With Iris Registration (ARCUATAS)
This is an observational, prospective follow-up post-marketing study of CE marked medical devices aimed at treating astigmatism in patients with cataracts.
- Trial name
- ARCUATAS (NCT05053620)
- Testing
- Calculation of the arcuate intrasomal incisions
- Where
- Spain
- Volunteers
- 22 people
- Sponsor
- OFTALVIST (Oftalmología Vistahermosa S.L)
Surgical Site Infection
Safety Study to Evaluate the Cumulative Irritation Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA
This is a safety study to determine the cumulative skin irritation potential of ZuraPrep™ and ZuraPrep™ without Isopropyl Alcohol after repetitive patch applications to skin of human subjects.
- Trial name
- NCT02160574
- Testing
- ChloraPrep, 0.1% Sodium Lauryl Sulfate, 0.9% Physiological Saline
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Zurex Pharma, Inc.
Orthopedic Disorders, Surgical Site Infection
Preoperative Decolonization and Surgical Site Infections - a Prospective Randomized Trial
Surgical site infections are a major postoperative complication and are mostly due to colonization with endogenous germs, like Staphylococcus aureus, Staphylococcus epidermidis or Propionibacterium acnes.
- Trial name
- DECO-SSI (NCT02560155)
- Testing
- Mupirocin 2% nasal ointement, Chlorhexidine sol 4%
- Where
- Switzerland
- Volunteers
- 1,300 people
- Sponsor
- Lindenhofgruppe AG
Surgical Wound, Healed
MPM Medical CoMatryx Surgical Bovine Collagen Study
The objective of this prospective enrollment study is to collect data confirming safety, performance and clinical benefits of the CoMatryx Surgical Collagen powder at a minimum 1-year follow-up and compare it to a historical…
- Trial name
- NCT04407364
- Testing
- CoMatryx Surgical Bovine Collagen
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- MPM Medical
Cholecystectomy, Benign Hysterectomy
Post Market Study for FloShield 10mm Reusable Cannula and Blunt Obturator and Robotic FloShield
This study evaluates the use of the FloShield System with the FloShield 10mm reusable Cannula and Oburator during standard robotic laparoscopic single-site surgery.
- Conditions
- Cholecystectomy, Benign Hysterectomy, Salingo-oophorectomy
- Trial name
- NCT02163239
- Testing
- Cannula and Blunt Obturator
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Minimally Invasive Devices, Inc.
Infections
Study to Evaluate Efficacy and Safety of E-101 Solution for Preventing Surgical Site Infections After Colorectal Surgery
This study is intended to determine the efficacy, safety and tolerability of topical application of E-101 Solution directly into the surgical incisional wound in the prevention of infection of superficial and deep surgical…
- Trial name
- Triple IN (NCT01297959)
- Testing
- E-101 Solution 300 GU/ml, Saline solution
- Where
- 39 sites in United States, Israel
- Volunteers
- 503 people
- Sponsor
- Excited States, LLC
Surgical Wound, Wound
Oasis Donor Site Wounds Post-Market Study
The purpose of this study is to demonstrate the safety and performance of Oasis extracellular matrix (ECM) when used as a treatment for donor site wounds in the United Kingdom.
- Conditions
- Surgical Wound, Wound, Wounds and Injuries, Wound Heal
- Trial name
- NCT04079348
- Testing
- Oasis ECM, standard wound care
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- Cook Biotech Incorporated
Surgical Site Infection, Staphylococcus Aureus Infection
Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG®
DUOFAG® is a phage cocktail containing bacteriophages active against Staphylococcus aureus and Pseudomonas aeruginosa. It is an investigational medicinal product for the treatment of surgical site infections caused by S.
- Conditions
- Surgical Site Infection, Staphylococcus Aureus Infection, Pseudomonas Aeruginosa Infection, Bacterial Infections
- Trial name
- NCT06319235
- Testing
- IMP
- Where
- Czechia
- Volunteers
- 52 people
- Sponsor
- MB PHARMA s.r.o.