Clinical trials: Surgical Injury
Wound; Rupture, Surgery, Cesarean Section, Postpartum Hemorrhage
HEMOLEVEN® Expanded Access Program Prevention of Surgical/Postpartum Hemorrhage Severe Inherited Factor XI Deficiency
The objective of the Expanded Access Program is to provide HEMOLEVEN, a replacement coagulation factor XI, to patients with severe inherited factor XI deficiency where, in the opinion of the treating physician, the benefits of…
- Conditions
- Wound; Rupture, Surgery, Cesarean Section, Postpartum Hemorrhage, Surgery
- Trial name
- EAP (NCT01701947)
- Testing
- Hemoleven
- Where
- United States
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
Surgical Wound Dehiscence
A Study, Performed in Subjects With Post Traumatic-post Surgical ,Venus Insufficiency and Diabetic Hard to Heal/Chronic Wounds, to Evaluate the Safety and Efficacy of PolyHeal-2 Versus PolyHeal in Once Daily Regimen
This is a double-blind , randomized, controlled, two-arm study aiming to evaluate the safety and efficacy of Polyheal-2 vs PolyHeal, in once daily application as compared to historical control.
- Trial name
- NCT01679678
- Testing
- PolyHeal 2, Polyheal
- Where
- 4 sites in Israel
- Volunteers
- 15 people
- Sponsor
- MediWound Ltd
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.
Vertebral Fracture, Compression Fracture
Spine Bone Cements Outcomes - Post Market Follow-up
A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all TEKNIMED Spine range of products: SPINEFIX, HIGH V+, OPACITY+ and F20 bone cements and mixing and injection systems, and all…
- Conditions
- Vertebral Fracture, Compression Fracture, Osteoporotic Fractures
- Trial name
- NCT06367582
- Testing
- Vertebroplasty (VP), Kyphoplasty (KP), Pedicular Screw Augmentation (PSA)
- Where
- 12 sites in France, Portugal and 2 more
- Volunteers
- 500 people
- Sponsor
- Teknimed
Rotator Cuff Tear
InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear
This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear .
- Trial name
- NCT02211183
- Testing
- Best Repair of torn Rotator Cuff, InSpace™ system
- Where
- Spain
- Volunteers
- 4 people
- Sponsor
- OrthoSpace Ltd.
Wounds and Injuries
A Study to Evaluate the Efficacy of Microlyte Matrix in the Management of Donor Site Wounds
A study to to evaluate the efficacy of Microlyte® Matrix by demonstrating its superiority to the standard of care in the healing of donor site wounds in patients requiring split-thickness grafting, as well as to assess the…
- Trial name
- NCT05439746
- Testing
- Microlyte® Matrix
- Volunteers
- 53 people
- Sponsor
- Imbed Biosciences
Cerebrospinal Fluid Leak
Evaluate the Safety and Performance of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery
The objective of the study is to clinically assess the safety and performance of the Dura Sealant Patch as a means of reducing intra- as well as post-operative CSF leakage in patients undergoing elective cranial intradural…
- Trial name
- NCT03566602
- Testing
- Dura Sealant Patch
- Where
- 3 sites in Netherlands, Switzerland
- Volunteers
- 40 people
- Sponsor
- Polyganics BV
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
Pressure Ulcers, Venous Ulcers
Prospective PuraPly™ AM Case Series Study
The PuraPly AM case series is a prospective, observational study for patients who have received PuraPly AM which consists of a collagen sheet coated with polyhexamethylene biguanide hydrochloride (PHMB) and is intended for the…
- Conditions
- Pressure Ulcers, Venous Ulcers, Diabetic Ulcers, Surgical Wounds
- Trial name
- NCT03070925
- Testing
- PuraPly™ Antimicrobial Wound Matrix
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Organogenesis
Burn, Trauma Wound
Multicenter Single-arm Trial to Investigate Clinical Outcomes When Cohealyx™ is Used for Full Thickness Wounds
The goal of this study is to look at clinical outcomes when Cohealyx Collagen Matrix is used to treat full thickness wounds after surgical excision in patients that require a skin graft to heal their wounds.
- Conditions
- Burn, Trauma Wound, Full Thickness Wounds, Surgical Wound
- Trial name
- Cohealyx I (NCT06787690)
- Testing
- Cohealyx
- Where
- 18 sites in United States
- Volunteers
- 41 people
- Sponsor
- Avita Medical
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
Wounds and Injuries, Hemostasis
The Hemostatic Effectiveness of "HANBIO" Gauze During Non-emergent Gynecology Surgery.
The objective of this study is to collect the hemostatic effectiveness and device safety data of "HANBIO" Gauze in subjects have acute wound result from gynecology surgery.
- Trial name
- NCT06715696
- Testing
- "HANBIO" Gauze (Sterilized, 1% Collagen)
- Where
- Taiwan
- Volunteers
- 40 people
- Sponsor
- HAN Biomedical Inc
Trauma, Arthropathy Shoulder
FH ORTHO Shoulder Observatory
This study is a real-life observatory designed to collect long-term clinical data on patients who have undergone shoulder joint replacement or repair following shoulder trauma.
- Trial name
- NCT06511856
- Testing
- ARROW
- Where
- 3 sites in France
- Volunteers
- 500 people
- Sponsor
- FH ORTHO
Ureter Injury
IS-001 Injection in Patients Undergoing Robotic-Assisted Colorectal Surgery
This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation
- Trial name
- NCT07346066
- Testing
- filricianine
- Where
- 9 sites in United States
- Volunteers
- 146 people
- Sponsor
- Intuitive Surgical
Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs)
Study of Miro3D Wound Matrix for Healing Wounds and Ulcers in Outpatient Care
This clinical study is being conducted to evaluate how well the Miro3D Wound Matrix helps heal difficult wounds and ulcerations in an outpatient care setting.
- Conditions
- Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs), Pressure Ulcers, Surgical Wound Dehiscence (SWD)
- Trial name
- NCT06939673
- Testing
- Acellular Porcine-Derived Wound Matrix
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Reprise Biomedical, Inc.
Impacted Third Molar, Postoperative Pain
Natural Enzyme Mouthwash After Third Molar Surgery
This clinical study investigates whether a natural enzyme-containing mouthwash (ORAL7®) can improve healing, pain and mouth opening after the surgical removal of impacted lower wisdom teeth (mandibular third molars), compared to…
- Conditions
- Impacted Third Molar, Postoperative Pain, Trismus, Wound Healing
- Trial name
- NCT07627945
- Testing
- ORAL7® Mouthwash, 0.2% Chlorhexidine Gluconate Mouthwash
- Where
- Malaysia
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- MBD MARKETING SDN. BHD.
Staphylococcus Aureus, Orthopaedic Surgery
Preoperative Decolonization and Surgical Site Infections in Orthopaedic Surgery - 2 Year Outcome in Prosthetic Surgery
Surgical site infections in orthopaedic surgery are a major problem. Decolonization has been suggested to reduce infection rates.
- Conditions
- Staphylococcus Aureus, Orthopaedic Surgery, Surgical Site Infection, Prevention
- Trial name
- DECO-SSI (NCT03962907)
- Testing
- Chlorhexidine, Lifo-Scrub sol 4%®, 500ml, B. Braun, BACTROBAN® Nasal ong
- Where
- Switzerland
- Volunteers
- 1,318 people
- Sponsor
- Lindenhofgruppe AG
Scar, Incision
A Safety and Efficacy Study to Evaluate AIV001 in Wound Healing Following Surgical Incision
To evaluate the safety, efficacy and pharmacokinetic profile of ascending concentrations of the study medication compared with vehicle in subjects with incisional wounds
- Conditions
- Scar, Incision, Abdominal, Wound (Morphologic Abnormality)
- Trial name
- NCT03639883
- Testing
- AIV001
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- AiViva BioPharma, Inc.
Cardiac Surgery, Bone Wax, NU-KNIT, Median Sternotomy, Deep Sternal Wound Infection, Surgical Site Infection
Surgicel NU-KNIT Vs Bone Wax on Median Sternotomy
Bone wax is traditionally used as part of surgical procedures to prevent bleeding from exposed spongy bone. It is an effective hemostatic device which creates a physical barrier.
- Trial name
- NBCS (NCT06869772)
- Testing
- Closure of sternotomy
- Where
- Qatar
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Hamad Medical Corporation
Dehiscence Wound
Efficacy Evaluation of ActiGraft in Secondary Closure of Abdominal Surgical Wound Dehiscence
This is a prospective, single arm study, consisting of 20 women with abdominal surgical wound dehiscence that requires secondary closure.
- Trial name
- NCT04899466
- Testing
- ActiGraft
- Where
- Israel
- Volunteers
- 20 people
- Sponsor
- RedDress Ltd.