Clinical trials: Surgical Wounds
Wound and Injuries, Surgical Wound Dehiscence
The Clinical Efficacy of RENASYS TOUCH NPWT System in the Management of Acute, Sub-acute and Chronic Wounds
The study is looking at the clinical efficacy, functionality and device performance of a new Negative Pressure Wound Therapy (NPWT) system in the management of a variety of wound types, in a real-life clinical setting.
- Trial name
- NPWT (NCT02565043)
- Testing
- RENASYS TOUCH Negative Pressure Wound Therapy System
- Where
- 2 sites in South Africa
- Volunteers
- 80 people
- Sponsor
- Smith & Nephew, Inc.
Postoperative Pain, Postoperative Edema
Patient Satisfaction and Recovery Outcomes Associated With Perioperative ELIXIR MD Use
The goal of this observational registry study is to characterize postoperative recovery outcomes in adult patients receiving standard-of-care perioperative light therapy using an FDA-cleared photobiomodulation device as part of…
- Conditions
- Postoperative Pain, Postoperative Edema, Postoperative Ecchymosis, Surgical Wound Healing
- Trial name
- NCT07311889
- Testing
- Perioperative photobiomodulation light therapy
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Elixir MD Inc
Breast Implant Complication, Breast Implant Shell Defect
Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Breast Implant Shell Fissure
This prospective implant-surveillance cohort will evaluate predictors of breast implant shell fissure. Women with aesthetic implants without baseline fissure or rupture will undergo annual clinical and imaging assessment for up…
- Trial name
- NCT07810257
- Testing
- Breast Implant Exposure, Structured Implant Shell Imaging
- Where
- Colombia
- Volunteers
- 3,000 people
- Sponsor
- Research Inc
Surgery, Pneumonia
Multicenter Infection Surveillance Study Following Open Heart Surgery
The main goals of the study are as follows: (1) to determine the correlation between pain management using continuous infusion of local anesthetics and the incidence of pneumonia and surgical infection in cardiac surgery…
- Conditions
- Surgery, Pneumonia, Surgical Site Infection
- Trial name
- NCT00673712
- Testing
- Continuous Sternal Block, Opioid based analgesia
- Where
- 8 sites in United States
- Volunteers
- 647 people
- Sponsor
- Halyard Health
Shoulder Pain, Shoulder Injuries
MDR SureLock All-Suture Anchor
To report the outcomes of a series of patients with recurrent anterior and/or posterior shoulder instability who underwent surgical repair of the affected labrum using the SureLock all-suture anchor.
- Conditions
- Shoulder Pain, Shoulder Injuries, Shoulder Disease, Shoulder Pain Chronic
- Trial name
- NCT04093700
- Testing
- SureLock All-Suture Anchor
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Zimmer Biomet
Patients Undergoing Clean Surgery
OPSITE Post-Op Visible Wound Dressings in Treatment of Surgical Incisions
OPSITE Post-Op Visible is a tri-layer dressing made up of a low adherent wound contact layer, lattice shaped absorbent pad and a top film that is waterproof and a bacterial barrier and is coated with a water-based adhesive.
- Trial name
- OPOV (NCT01577225)
- Testing
- OPSITE POST-OP VISIBLE, Tape and Gauze
- Where
- 6 sites in China
- Volunteers
- 100 people
- Sponsor
- Smith & Nephew Medical (Shanghai) Ltd
Wounds
Evaluation of Skin Affix in the Emergency Room
Effectiveness of a surgical adhesive on wounds found in Emergency Medicine.
- Trial name
- NCT02223689
- Testing
- Skin Affix
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Medline Industries
Traumatic Lacerations or Surgical Incisions
Safety and Efficacy Study of BondEase to Treat Traumatic Lacerations and Surgical Incisions
To demonstrate that BondEase™ and conventional wound closure devices (CWCD) are the same in terms of cosmesis (appearance) of the repaired wound when these devices are used for closure of surgical and traumatic wounds .
- Trial name
- NCT01716013
- Testing
- BondEase, CWCD
- Where
- 6 sites in United States
- Volunteers
- 162 people
- Sponsor
- OptMed, Inc.
Mandibular Fractures, Facial Fracture
Stryker Facial iD Universal Plate Configurator: A Retrospective Post Market Follow Up
A retrospective post market follow up to confirm safety and performance of Stryker's Facial iD Universal Plate Configurator (UPC) implants in the clinical setting.
- Conditions
- Mandibular Fractures, Facial Fracture, Maxilla Fracture, Orthognathic Surgical Procedures
- Trial name
- UPC (NCT07245810)
- Testing
- Orthognatic surgery, Reconstructive maxillofacial surgery, Mandible and maxillofacial trauma surgery
- Where
- 2 sites in United States
- Volunteers
- 726 people
- Sponsor
- Stryker Craniomaxillofacial
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
Tendon Injuries
Adaprev in Digital Flexor Tendon Repair
This study is being undertaken to verify the safety and performance of Adaprev™, a Class III medical device, when administered as a short term implant into the tendon sheath at the time of surgery, on the post-operative function…
- Trial name
- NCT01014494
- Testing
- Adaprev
- Where
- 9 sites in United Kingdom
- Volunteers
- 44 people
- Sponsor
- Renovo
Surgical Incisions
LiquiBand Versus Dermabond Versus Sutures for Closure of Surgical Wounds
To evaluate the cosmetic outcome, effectiveness, user and subject satisfaction, and safety of LiquiBand® Flex in relation to DermaBond Advanced™ and conventional sutures for the topical closure of surgical wounds.
- Trial name
- NCT01835405
- Testing
- LiquiBand Flex, Dermabond Advanced, Sutures (Prolene)
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- Advanced Medical Solutions Ltd.
Surgical Site Infection
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
The aim of the study is to elucidate, if the colonization of bacteria is lower on the Novosyn® CHD suture compared to uncoated Polyglactin 910 suture, which will be assessed by the incidence of surgical site infections (SSI: A1…
- Trial name
- POLYNOVO-CHD (NCT05966961)
- Testing
- Novosyn® in emergency or elective laparotomy or laparoscopic surgery, Polyglactin 910 in emergency or elective laparotomy or laparoscopic surgery
- Where
- 4 sites in Italy, Spain
- Volunteers
- 2,998 people
- Sponsor
- Aesculap AG
Elective Cranial Procedures With Dural Incision
DuraSeal Sealant Post Market Study
DuraSeal Dural Sealant has been approved as a dural sealant by the FDA for use in cranial and spinal procedures. This study was completed to further evaluate the safety of the DuraSeal Sealant in a post-approval setting as…
- Trial name
- NCT00704340
- Testing
- DuraSeal Dural Sealant System, Standard of Care
- Where
- United States
- Volunteers
- 237 people
- Sponsor
- Integra LifeSciences Corporation
Hernia, Ventral, Hernia, Hiatal
GORE® ENFORM Biomaterial Product Study
A prospective, retrospective, non-randomized, multicenter study with two independent hernia study cohorts (Ventral / Incisional Hernia Repair and Diaphragmatic / Hiatal Hernia Repair).
- Conditions
- Hernia, Ventral, Hernia, Hiatal, Hernia, Diaphragmatic, Incisional Hernia
- Trial name
- ENF 18-06 (NCT04718168)
- Testing
- Gore ENFORM Biomaterial (Preperitoneal), Gore ENFORM Biomaterial (Intraperitoneal)
- Where
- 9 sites in United States
- Volunteers
- 245 people
- Sponsor
- W.L.Gore & Associates
Surgical Incision, Ulcer Foot
Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds
This is a prospective, multi-center, open label study evaluating the performance of PICO14 Negative Pressure Wound Therapy (NPWT) in the management of chronic open wounds (pressure ulcers, venous leg ulcers, diabetes related foot…
- Conditions
- Surgical Incision, Ulcer Foot, Ulcer Venous, Ulcer, Leg
- Trial name
- PICO14 (NCT05234632)
- Testing
- PICO 14 single-use Negative Pressure Wound Therapy System
- Where
- 6 sites in Germany, United Kingdom
- Volunteers
- 45 people
- Sponsor
- Smith & Nephew, Inc.
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
VASCADE ANTEGRADE-PVD Post-Market Registry
The objective of the registry is to collect procedural outcomes data when the Cardiva VASCADE Vascular Closure System (VCS) is used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional…
- Trial name
- NCT02948257
- Testing
- Cardiva Medical VASCADE VCS
- Where
- 5 sites in United States
- Volunteers
- 52 people
- Sponsor
- Cardiva Medical, Inc.
Cutaneous Wounds
Safety and Efficacy of ActiGraft Treatment in Wound Care in Medical Centers
Multicenter observational study to explore the efficacy of ActiGraft in the treatment of exuding cutaneous wounds in real-life usage.
- Trial name
- NCT04699305
- Testing
- ActiGraft
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- RedDress Ltd.
Post Surgical Wound
Evaluation of a Novel Post-Surgical Dressing
The purpose of this study is to evaluate the safety and efficacy of the Closed-Incision SNaP Device.
- Trial name
- NCT01831596
- Testing
- ciSNaP
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- KCI USA, Inc