Clinical trials: Surgical Injury
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
Surgical Wound, Revision Total Knee Arthroplasty
Closed Incision Negative Pressure Therapy Versus Standard of Care Surgical Dressing in Revision Total Knee Arthroplasty
This study evaluates surgical site complications in subjects undergoing revision of a total knee arthroplasty when closed incision negative pressure therapy is used to manage the closed incision, as compared to a standard of care…
- Conditions
- Surgical Wound, Revision Total Knee Arthroplasty, Wounds and Injuries, Joint Disease
- Trial name
- PROMISES (NCT03274466)
- Testing
- Closed Incision Negative Pressure Therapy (ciNPT), Standard of Care Dressing
- Where
- 17 sites in United States
- Volunteers
- 294 people
- Sponsor
- KCI USA, Inc
Breast Cancer
Coated VICRYL* Plus Suture Compared to Chinese Silk in Scheduled Breast Cancer Surgery
This is a 90-day study to evaluate cosmetic outcome and Surgical Site Infection in approximately 100 patients from 6 centers in China undergoing scheduled modified radical mastectomy for breast cancer.
- Trial name
- NCT00768222
- Testing
- silk suture, VICRYL* Plus suture
- Where
- 6 sites in China
- Volunteers
- 101 people
- Sponsor
- Ethicon, Inc.
Knee Injuries, Joint Surface Knee Lesions
A Post Approval Multicenter 10 Year Follow-up Observational Trial of Marketed Product - MP01 vs. Surgical Standard of Care (SSOC) Used for the Treatment of Joint Surface Lesions of the Knee
The purpose of the study is to support market adoption and global market access via collection of long-term effectiveness, safety, and radiographic data.
- Trial name
- NCT06916728
- Testing
- Marketed Product - MP01, Surgical Standard of Care
- Where
- 8 sites in United States, Belgium and 4 more
- Volunteers
- 170 people
- Sponsor
- Smith & Nephew, Inc.
Spinal Cord Neoplasms, Spinal Fractures
The Development of a Vertebra Localizing Aid Medical Device
The current method of incision localization in many surgical procedures requires a doctor to reference a medical image, such as an X-ray, to judge where on the body an incision should be made.
- Trial name
- NCT02603874
- Testing
- Target Tape
- Volunteers
- 100 people
- Sponsor
- Target Tape
ACL Injury
Effects of HMB Supplementation on Recovery Following ACL Surgery
The anterior cruciate ligament (ACL) is a primary stabilizer of the knee, and thus when ACL injury occurs participation in physical activity is compromised.
- Trial name
- NCT02602561
- Testing
- HMB
- Where
- United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Metabolic Technologies Inc.
Surgical Wound Infection
Clinical Assessment of Next Science Solution on Gustilo and Anderson Type II and IIIA or IIIB Tibial Fractures
This is a prospective, randomized, controlled, double-blinded clinical feasibility study of subjects that are being treated for Gustilo and Anderson Type II or IIIA or IIIB Tibial Fractures
- Trial name
- NCT04906642
- Testing
- Next Science, Standard of Care
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- Next Science TM
Elastosis
PEAK PlasmaBlade™ vs. Traditional Electrosurgery in Abdominoplasty
The objective of this clinical study is to evaluate healing of incisions made with the PEAK PlasmaBlade 4.0 compared to scalpel and traditional electrosurgery (Bovie); to monitor and record key post-operative metrics following…
- Trial name
- PRECISE (NCT00943150)
- Testing
- PEAK PlasmaBlade, Standard of Care (SOC)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Medtronic Surgical Technologies
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
Full-thickness Skin Defects, Degloving Injuries
RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction
A prospective randomized within-subject controlled study to compare the clinical performance of conventional autografting with and without the RECELL system on acute non-burn full-thickness skin defects.
- Conditions
- Full-thickness Skin Defects, Degloving Injuries, Crush Injuries, Laceration of Skin
- Trial name
- NCT04091672
- Testing
- Control Intervention (Conventional Autograft), Investigational Intervention (RECELL + more widely meshed autograft)
- Where
- 18 sites in United States
- Volunteers
- 65 people
- Sponsor
- Avita Medical
Laparoscopic Surgery
Clinical Trial of MedLogic LiquiBand Laparoscopic Versus Dermabond in the Closure of Surgical Incisions
To evaluate the effectiveness, safety, and utility of LiquiBand Laparoscopic™ in relation to a currently approved active control product (High Viscosity DermaBond).
- Trial name
- NCT00762905
- Testing
- LiquiBand Laparoscopic, Dermabond
- Where
- 4 sites in United Kingdom
- Volunteers
- 460 people
- Sponsor
- MedLogic Global Limited
Osteo Arthritis Shoulders
Air Barrier System for the Reduction of Airborne Colony-forming Units During Total Shoulder Arthroplasty
The objective of this study is to determine whether the Air Barrier System device reduces airborne colony-forming units (e.g., bacteria) present at a surgery site during total shoulder arthroplasty surgeries.
- Trial name
- NCT03782675
- Testing
- Control, Air Barrier System
- Volunteers
- 40 people
- Sponsor
- Nimbic Systems, LLC
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.
Fractures, Open, Fractures, Closed
LOQTEQ® Antibacterial Pre-Market Study
aap001 is a randomized, controlled, subject-blinded, multi-center study to show the safety of the LOQTEQ® antibacterial silver-coated system is non-inferior in comparison with the uncoated LOQTEQ® system
- Conditions
- Fractures, Open, Fractures, Closed, Surgical Site Infection, Fracture of Fibula
- Trial name
- NCT05260463
- Testing
- Implantation
- Where
- 13 sites in Germany
- Volunteers
- 203 people
- Sponsor
- aap Implantate AG
Hyperalgesia, Neurodynia
GW406381 In Patients With Peripheral Nerve Injury
The findings from preclinical animal models confirm the peripheral anti-inflammatory/analgesic activity of GW406381 and also suggest contribution of a central site of action to the anti-hyperalgesic efficacy that may not be…
- Conditions
- Hyperalgesia, Neurodynia, Pain, Trauma
- Trial name
- NCT00279032
- Testing
- GW406381
- Where
- 5 sites in United Kingdom
- Volunteers
- 40 people
- Sponsor
- GlaxoSmithKline
Intraoperative Ureter Injury
Open-label Study to Evaluate Nerindocianine as a Surgical Aid in Ureter Delineation During Minimally Invasive Surgery
Phase 2, multicenter, efficacy and safety study evaluating the use of nerindocianine for the delineation of abdominopelvic ureter anatomy via near infrared fluorescence imaging during minimally invasive lower abdominal surgery…
- Trial name
- NCT04636567
- Testing
- Nerindocianine for injection
- Where
- 2 sites in United States
- Sponsor
- Li-Cor, Inc.
Pain, Postoperative
Safety and Efficacy of Repeated Doses of PMI-150 (Intranasal Ketamine) in Acute Post-operative Pain Following Orthopedic Surgery
The purpose of this research study is to evaluate the safety and analgesic efficacy of PMI-150 (intranasal ketamine) compared to placebo in patients with acute post-operative pain following orthopedic trauma, injury, or surgery.
- Trial name
- NCT00709436
- Testing
- PMI-150 (intranasal ketamine)
- Where
- 16 sites in United States
- Volunteers
- 250 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Acute Pain
A Multi-Center Study of the Efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of IV Acetaminophen for the Treatment of Acute Pain in Pediatric Patients
The purpose of this study is to demonstrate the efficacy and safety of Intravenous (IV) acetaminophen plus rescue opioids for the relief of moderate to severe acute pain in neonates and infants (age < 2 years) compared to placebo…
- Trial name
- NCT01635101
- Testing
- IV Acetaminophen, IV Control
- Where
- 22 sites in United States
- Volunteers
- 197 people
- Sponsor
- Mallinckrodt
Surgical Wound
Healing Ointment Usage Post-surgical Procedure
To evaluate benefits of a Healing Ointment in skin improvement after dermatologic procedures
- Trial name
- Cetaphil (NCT05686928)
- Testing
- Cetaphil Healing Ointment
- Where
- 2 sites in United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Galderma R&D
Surgical Site Infection
Air Barrier System for the Prevention of Surgical Site Infection
Airborne particles are present in all indoor environments including the operating room. Most of these particles come from the surgical staff moving around in the room, positioning of the patient during surgery, and the movement…
- Trial name
- ABS (NCT01610271)
- Testing
- Air Barrier System
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Nimbic Systems, LLC