Clinical trials: Surgical Injury
Surgical Wounds
Evaluation of the KLOX BioPhotonic WoundGel System in the Treatment of Surgical Wounds
This is a multicenter, randomized, prospective, controlled study in patients having bilateral breast reduction. Objectives of the study are to evaluate the safety and efficacy of the KLOX BioPhotonic WoundGel System compared with…
- Trial name
- NCT02604251
- Testing
- KLOX BioPhotonic WoundGel System, Silicone sheets
- Where
- 2 sites in Canada
- Volunteers
- 42 people
- Sponsor
- KLOX Technologies Inc.
Surgical Wound
A Post-Market Clinical Investigation on Mepilex Border Post-Op
This is a retrospective, observational (non-interventional), single-arm, single-centre, post-market clinical investigation designed to verify clinical performance and safety of Mepilex Border Post-Op when used according to…
- Trial name
- ARCTIS (NCT04994145)
- Where
- Belgium
- Volunteers
- 560 people
- Sponsor
- Molnlycke Health Care AB
Surgical Site Infection
Pilot Clinical Evaluation to Characterize in Vivo Effects of Topically Applied ZuraPrep & ZuraPrep Vehicle
ZuraPrep is being evaluated for efficacy as a preoperative skin preparation solution to demonstrate its immediate and persistent antimicrobial properties.
- Trial name
- NCT02578771
- Testing
- ZuraPrep with 70% IPA, ZuraPrep without 70% IPA, ChloraPrep CHG/IPA Teal Tint
- Where
- United States
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- Zurex Pharma, Inc.
Surgical Site Infection, Sternal Infection
D-PLEX 302: Efficacy and Safety of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery
Prospective, Multinational, Multicenter, Randomized, Parallel Controlled, Two arms, Single Blind, Study to Assess the Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SOC) IV Prophylactic…
- Conditions
- Surgical Site Infection, Sternal Infection, Cardiac Surgery
- Trial name
- NCT03558984
- Testing
- D-PLEX, Standard of Care
- Where
- 3 sites in United States, Israel
- Volunteers
- 2 people
- Sponsor
- PolyPid Ltd.
Hip Arthritis, Osteoarthritis, Hip
Observational Study to Collect Safety Data and PROMs on Primary THA
This observational study is designed to collect safety data and PROMs on retrospective primary total hipa arthroplasty surgeries with Trinity cup and Meije Duo cementless hip system
- Conditions
- Hip Arthritis, Osteoarthritis, Hip, Coxitis, Femoral Head Necrosis
- Trial name
- NCT06518993
- Testing
- Total hip arthroplasty with a Trinity cup and a Meije Duo cementless stem
- Where
- France
- Volunteers
- 116 people
- Sponsor
- Corin
Neoplasm of Skin
Use of the Epidermal Micrografts for Wound Healing After Mohs or Excisional Surgery for Skin Cancer
This case series will assess the use of suction blister epidermal grafts harvested by a novel device on select patients that have wounds from Mohs or excisional surgery.
- Trial name
- NCT01536444
- Testing
- Momelan Technologies Epidermal Graft Harvesting System
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Momelan Technologies
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
Third Degree Burn, Burns
StrataGraft™ Skin Tissue (Human Donor Skin) In The Surgical Management Of Complex Skin Defects
This pilot Phase I/II clinical study will be conducted at up to three clinical sites. This is an open-label, randomized, comparative study with a maximum of fifteen (15) patients, each with skin defects.
- Conditions
- Third Degree Burn, Burns, Wound Infection, Degloving Injury
- Trial name
- NCT00618839
- Testing
- StrataGraft Skin Tissue, Cadaver allograft
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Stratatech, a Mallinckrodt Company
Preemptive Therapy of Patients At Risk for Acute Kidney Injury Following Cardiac Surgery
Phase 1B/2 Clinical Trial Assessing the Safety, Tolerability and Preliminary Efficacy of the Intravenous Administration of Allogeneic Placental Mesenchymal Cells for the Preemptive Treatment of Patients At Risk for Acute Kidney Injury Following Cardiac Surgery
This clinical trial is designed to evaluate KELI-101 versus placebo for the prevention of acute kidney disease leading to chronic kidney disease in subjects at high risk for acute kidney injury following cardiac surgery.
- Trial name
- MesAKI (NCT06678399)
- Testing
- KELI-101
- Volunteers
- 91 people
- Sponsor
- Kelifarma
Surgical Wound, Trauma Wound
Randomized Controlled Trial to Investigate Clinical Outcomes and Associated Costs When PermeaDerm is Used as Temporary Dressing for Surgical Wounds
The goal of this study is to compare the cost and clinical outcomes for two temporary dressings (Allograft and PermeaDerm) used in patients that need a skin graft to heal their wound.
- Conditions
- Surgical Wound, Trauma Wound, Autografts, Partial-thickness Burn
- Trial name
- NCT06750809
- Testing
- PermeaDerm Biosynthetic Wound Matrix, Frozen Human Cadaveric Allograft (FHCA)
- Where
- 13 sites in United States
- Volunteers
- 40 people
- Sponsor
- Avita Medical
Shoulder Injuries, Shoulder Disease
Cryopneumatic Device After Shoulder Surgeries
This study randomize patients to receive either a cryopneumatic device or standard care (ice and ice packs) following open or arthroscopic shoulder surgeries.
- Trial name
- NCT04185064
- Testing
- Game Ready ATX shoulder wrap; Game Ready GRPro 2.1, Standard Care
- Where
- 5 sites in Canada
- Volunteers
- 200 people
- Sponsor
- Encore Research Inc.
Bacterial Infection
Efficacy and Safety of Ceftaroline Versus Linezolid in Subjects With Complicated Skin and Skin Structure Infections
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin and skin structure infections in adults.
- Trial name
- NCT00633152
- Testing
- ceftaroline, linezolid, Aztreonam
- Where
- 13 sites in United States
- Volunteers
- 150 people
- Sponsor
- Forest Laboratories
Oncoplastic Breast Surgery, Bilateral Surgery
A Clinical Study to Assess the Safety and Clinical Performance of a New Dressing (PICO7Y) in Breast Surgery Patients
The purpose of the study is to assess the use of a wound dressing system called PICO7Y following a two-sided breast surgery. PICO7Y is a new dressing system made to treat two incisions/wounds at the same time, and the purpose of…
- Trial name
- PICO7Y (NCT03835845)
- Testing
- PICO7Y
- Where
- 5 sites in Netherlands, United Kingdom
- Volunteers
- 40 people
- Sponsor
- Smith & Nephew, Inc.
Carpal Tunnel Syndrome (CTS)
Evaluation of Dynavisc in Pain Reduction Following Revision Surgery for Persistent or Recurrent Carpal Tunnel Syndrome
The trial will evaluate the efficacy of DYNAVISC in subjects with a diagnosis of persistent or recurrent carpal tunnel syndrome. This is a prospective, multicenter, randomized, evaluator-blinded clinical trial.
- Trial name
- NCT06593977
- Testing
- Dynavisc
- Where
- 4 sites in Belgium, Brazil and 1 more
- Volunteers
- 50 people
- Sponsor
- FzioMed
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
Pressure Ulcer, Venous Ulcer
PuraPly™ Antimicrobial Wound Matrix and Wound Management
The PuraPly Antimicrobial Wound Matrix (PuraPly AM) case series is a prospective, observational study for patients who have received PuraPly AM which consists of a collagen sheet coated with polyhexamethylenbiguanide…
- Conditions
- Pressure Ulcer, Venous Ulcer, Diabetic Ulcer, Surgical Wound
- Trial name
- PuraPlyAM (NCT03070938)
- Testing
- PuraPly™ Antimicrobial Wound Matrix
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Organogenesis
Leg Injuries, Winter Sport Resorts
Evaluation of the Prevention of Thromboembolic Disease in Patients With a Lower Limb Trauma, Non Surgical, in Winter Sports Resort
The purpose of this study is to evaluate the impact of thromboembolic diseases and heparin complications in patients with a lower limb trauma supported by physicians of mountain.
- Conditions
- Leg Injuries, Winter Sport Resorts, Outpatients
- Trial name
- M2M-Thrombose (NCT01303523)
- Where
- 28 sites in France
- Volunteers
- 1,627 people
- Sponsor
- Floralis
Hereditary Transthyretin Amyloidosis, Carpal Tunnel Syndrome
Hereditary Transthyretin Amyloidosis Polyneuropathy in Patients With Carpal Tunnel Syndrome in Russia
This is a multicenter observational study consisting of retrospective and prospective phases. The retrospective phase will entail secondary data collection from electronic or paper medical records of patients who underwent…
- Conditions
- Hereditary Transthyretin Amyloidosis, Carpal Tunnel Syndrome, Polyneuropathy, Amyloidosis
- Trial name
- LOCUS (NCT06414746)
- Where
- 13 sites in Russia
- Volunteers
- 721 people
- Sponsor
- AstraZeneca
Cardiac Surgery, Sternal Wound Infection
Safety and Efficacy of an Antibiotic Implant in Cardiac Surgical Subjects at Higher Risk for Sternal Wound Infection
The purpose of this study is to determine whether the gentamicin-collagen sponge is safe and effective in preventing sternal wound infections in patients undergoing cardiac surgery who are at a greater risk of developing sternal…
- Trial name
- NCT00600483
- Testing
- gentamicin-collagen sponge dipped in saline
- Where
- 43 sites in United States
- Volunteers
- 1,502 people
- Sponsor
- Innocoll
Wounds, Pressure Ulcer
Kerecis Real-World Fish Skin Graft Registry
Multi-center, observational (i.e., non-interventional), open-label, real-world Registry on the Use of Kerecis Devices
- Conditions
- Wounds, Pressure Ulcer, Diabetic Foot Ulcer, Venous Leg Ulcer
- Trial name
- ISACOD (NCT06384183)
- Testing
- Kerecis Fish Skin Graft
- Where
- 6 sites in United States
- Volunteers
- 600 people
- Sponsor
- Kerecis Ltd.