Clinical trials: Open Surgical Wounds
Burn Injury, Skin Graft
A Soft Silicone Wound Contact Layer Containing Silver in the Treatment of Skin Grafts in Surgical Burn Patients.
Part A The primary objective of Part A will be to verify performance and safety of Mepitel® Ag, a meshed, non- adherent soft silicone wound contact layer containing silver in the treatment of skin grafts in surgical burn…
- Trial name
- MpTAg03 (NCT02210208)
- Testing
- Mepitel® Ag, Mepilex® Transfer Ag
- Where
- 4 sites in United States
- Volunteers
- 25 people
- Sponsor
- Molnlycke Health Care AB
Cerebrospinal Fluid Leaks
TASALL - TachoSil® Against Liquor Leak
The primary objective is to demonstrate superiority of TachoSil® compared to current practice as an adjunct in sealing the dura mater. The efficacy of the dura mater sealing must be evaluated post-operatively.
- Trial name
- NCT01355627
- Testing
- TachoSil®, Current Practice
- Where
- 39 sites in Austria, Belgium and 9 more
- Volunteers
- 726 people
- Sponsor
- Takeda
Surgical Site Infections
Study to Assess the Safety & Efficacy of Oral Ciprodiazole Versus Currently Used Ciprofloxacin & Metronidazole
This study aims to assess the safety \& efficacy of Oral Ciprodiazole® versus currently used Ciprofloxacin Tablets \& Metronidazole tablets in pelvi-abdominal infections and following IV antibiotics in post-operative period, for…
- Trial name
- CIPRO-001 (NCT05863832)
- Testing
- Ciprodiazole, Ciprofloxacin Tablets & Metronidazole tablets
- Where
- Egypt
- Volunteers
- 312 people
- Sponsor
- MinaPharm Pharmaceuticals
Disc Degenerative Disease, Spondylolisthesis
A Clinical Study of a Spine Fusion System in Vertebral Body Fusion Surgery
The primary objective of this study is to demonstrate that the efficacy and safety of Spine fusion system manufactured in China is no inferior than imported product.
- Conditions
- Disc Degenerative Disease, Spondylolisthesis, Spinal Fracture, Spinal Deformity
- Trial name
- NCT02252185
- Testing
- Johnson&Johnson Medical Suzhou made Spine Fusion System, Imported EXPEDIUM screws and OPAL cage
- Where
- 8 sites in China
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Medical (Suzhou) Ltd.
Tibial Fractures
Safety Study of Treatment of Leg Fractures
This study evaluates the safety of the EVOS SMALL Plating system in patients who have a fracture of the tibia requiring surgery.
- Trial name
- EVOS SMALL (NCT03881241)
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- Smith & Nephew, Inc.
Failed Lumbar Fusion
Study on Allogeneic Osteoblastic Cells Implantation in Rescue Interbody Fusion
Failed fusion and failure to relieve back pain following spinal fusion are still frequent, irrespective of the type of procedures or grafts used by the surgeon.
- Trial name
- NCT02328287
- Testing
- ALLOB®
- Where
- 3 sites in Belgium
- Volunteers
- 6 people
- Sponsor
- Bone Therapeutics S.A
Wounds Injuries, Anesthesia, Local
Single-centre Study to Investigate Safety and Efficacy of Tri-Solfen in Wound Debridement
This is a Phase IIa open, randomised, single and parallel group, therapy controlled, single centre study, which has been divided into 3 sequential phases, which are designed to study respectively, (a) the time taken to achieve…
- Trial name
- NCT03865147
- Testing
- Tri-Solfen Gel (Lidocaine HCl, Bupivacaine HCl, Adrenaline Acid Tartrate /Cetrimide), EMLA cream, Post Operative Analgesia (Paracetamol, Ibuprofen)
- Where
- United Kingdom
- Volunteers
- 90 people
- Sponsor
- Medical Ethics UK Ltd
Delayed Healing
PICO Breast Reduction Clinical Study Looking at Incision Healing Complications
The purpose of this study is to see if the use of a single-use negative pressure wound therapy system (NPWT) will have an effect on the reduction of post-surgical incision healing complications following breast reduction surgery…
- Trial name
- NCT01640366
- Testing
- PICO
- Where
- 6 sites in United States, France and 2 more
- Volunteers
- 200 people
- Sponsor
- Smith & Nephew, 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
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
Surgical Wound, Trauma-related Wound
A Prospective, Multi Centre, Interventional, Non-comparator, Open Label Study to Demonstrate the Efficacy, Performance and Safety of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive Dressings in the Management of Surgical and Traumatic Wounds
A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, performance and safety of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive dressings in the management…
- Trial name
- MATILDA (NCT05632276)
- Testing
- ConvaFoam
- Where
- 2 sites in United States
- Volunteers
- 54 people
- Sponsor
- ConvaTec Inc.
Incision, Surgical, Surgical Incision
A Safety and Performance PMCF Investigation of the Avance® Solo NPWT System in Surgically Closed Incisions
The ASOLO-SCI investigation is a Post Market Clinical Follow-up (PMCF) study to investigate the safety and performance of the Avance® Solo NPWT System in treating low to moderate exuding surgically closed incisions for up to 14…
- Conditions
- Incision, Surgical, Surgical Incision, Surgical Wound, Surgical Wound, Recent
- Trial name
- ASOLO-SCI (NCT04894604)
- Testing
- Avance® Solo NPWT System
- Volunteers
- 34 people
- Sponsor
- Molnlycke Health Care AB
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.
Acute Non Infected Wounds, Non Infected Post Surgical Wounds
A Prospective, Open, Non-controlled Clinical Investigation to Evaluate a New Negative Pressure Wound Therapy (NPWT) System to be Used in the Treatment of Acute Non-infected Wounds and Post Surgical Infected Wounds
The investigation is designed as a prospective, open, non-controlled clinical investigation.
- Trial name
- NCT01195896
- Testing
- New NPWT system
- Where
- Germany
- Volunteers
- 9 people
- Sponsor
- Molnlycke Health Care AB
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.
Leg Ulcer, Diabetic Foot Ulcer
Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia
The purpose of this reseach study is to determine Mölnlycke Health Care´s Leia dressing performance properties is fulfilled and that the dressing is safe when used on wound types such as pressure ulcer, leg ulcer, and diabetic…
- Conditions
- Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer
- Trial name
- NCT01966380
- Testing
- Leia
- Where
- Sweden
- Volunteers
- 6 people
- Sponsor
- Molnlycke Health Care AB
Tibial Fracture
Study Evaluating CERAMENT™|G in Open Diaphyseal Tibial Fractures
The purpose of this study is to demonstrate the safety and effectiveness of CERAMENT™|G used in conjunction with standard-of-care treatment compared to standard-of-care treatment alone in the care of subjects with open fractures…
- Trial name
- NCT02820363
- Testing
- CERAMENT|G, SOC treatment
- Where
- 31 sites in United States, Germany and 2 more
- Volunteers
- 201 people
- Sponsor
- BONESUPPORT AB
Hernia, Obesity
Evaluation of Surgisis Gold Graft for Incision Reinforcement After Open Bariatric Surgery
The primary objective is to compare the effectiveness of the Surgisis Gold Graft to suture closure alone in preventing an incisional hernia after open bariatric surgery.
- Trial name
- NCT00274625
- Testing
- Surgisis Gold Graft, Control
- Where
- 2 sites in United States
- Volunteers
- 402 people
- Sponsor
- Cook Group Incorporated
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
Trauma-related Wound, Surgical Incision
3M™ Topical Tissue Adhesive Versus Commercially Available Tissue Adhesive for the Closure of Lacerations and Incisions
The purpose of this study is to generate safety and performance data for 3M™ Topical Tissue Adhesive. Enrolled subjects with qualifying trauma lacerations or surgical incisions will be randomized to receive 3M™ Topical Tissue…
- Conditions
- Trauma-related Wound, Surgical Incision, Surgical Wound, Laceration
- Trial name
- Lublin (NCT06217081)
- Testing
- 3M Topical Tissue Adhesive, Histoacryl® Blue Topical Skin Adhesive
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Solventum US LLC