Clinical trials: Trauma to the Abdomen
Surgical Site Infection, Colon Surgery
D-PLEX 311: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection
Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to assess Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SoC), compared to a SoC treated…
- Conditions
- Surgical Site Infection, Colon Surgery, Abdominal Surgery, Post-Op Infection
- Trial name
- NCT04233424
- Testing
- D-PLEX, Standard of Care (SoC)
- Where
- 62 sites in United States, Bulgaria and 8 more
- Volunteers
- 977 people
- Sponsor
- PolyPid Ltd.
Wound Heal
Performance, Safety and Efficacy of PICO Device.
The study is being conducted to evaluate the safe and effective use of the PICO 7 system in surgically closed incision sites and wounds requiring closure by skin graft or flap as part of the PMCF plan for this product, for the…
- Trial name
- NCT03698968
- Testing
- Negative Pressure Wound Therapy
- Where
- 11 sites in Switzerland, United Kingdom
- Volunteers
- 50 people
- Sponsor
- Smith & Nephew, Inc.
Appendicitis, Cholecystitis
NOVOsyn® for Trocar Incision After Laparoscopic Appendectomy and Cholecystectomy
The aim of this study is to evaluate if the application of a Chlorhexidine coated suture (Novosyn® CHD) will reduce the colonization of bacteria in comparison to an uncoated suture (Novosyn®) used for the closure of trocar wounds…
- Trial name
- NOVOTILAC (NCT04033211)
- Testing
- Novosyn® CHD for fascia and skin closure, Novosyn® for fascia and skin closure
- Where
- 4 sites in Germany, Spain
- Volunteers
- 316 people
- Sponsor
- Aesculap AG
Abscess, Intra-Abdominal, Abdominal Abscess
A Safety and Tolerability Study of Doripenem Compared With Meropenem in Children Hospitalized With Complicated Intra-abdominal Infections
The purpose of the study is to evaluate the safety and tolerability of doripenem compared with meropenem in children hospitalized with complicated intra-abdominal infections.
- Conditions
- Abscess, Intra-Abdominal, Abdominal Abscess, Abdomen, Acute, Abdominal Pain
- Trial name
- NCT01110382
- Testing
- Doripenem, Meropenem, Amoxicillin/clavulanate potassium
- Where
- 19 sites in United States, Argentina and 6 more
- Volunteers
- 41 people
- Sponsor
- Janssen Research & Development, LLC
Abdominal Injury, Thoracic Diseases
A Post Market Study to Confirm the Safety and Performance of the Signia™ Stapling System.
The objectives of this prospective, two-arm, multicenter post-market study is to confirm safety and performance through the incidence of subjects reporting serious adverse device effects (ADEs) up to and including 30 days…
- Trial name
- NCT03515811
- Testing
- Signia™ Stapling System
- Where
- 11 sites in United States, Canada and 3 more
- Volunteers
- 136 people
- Sponsor
- Medtronic - MITG
Abdomenal Wound Trauma
Non-Comparative Study of Open Abdomen That Require the Use of Negative Pressure Wound Therapy (NPWT) for Temporary Abdominal Closure
A study in which subjects with a Grade 1 or Grade 2 open abdomen that require the use of NPWT for temporary abdominal closure. Subjects will use the NPWT system for up to 14 days, with a 21 day post study initiation follow-up…
- Trial name
- NCT03431220
- Testing
- RENASYS® TOUCH Negative Pressure Wound Therapy (NPWT) Device
- Where
- United States
- Sponsor
- Smith & Nephew, Inc.
Abdominal Surgery, Colon Surgery
D-PLEX 310: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection
Subjects who are planned to undergo an abdominal (colon) surgery and who will meet the study entry criteria will be randomly divided into 2 groups: for half D-PLEX will be administered concomitantly with the standard of care…
- Conditions
- Abdominal Surgery, Colon Surgery, Post-Op Infection
- Trial name
- NCT03633123
- Testing
- D-PLEX, Standard of Care (SoC)
- Where
- 8 sites in Israel
- Volunteers
- 202 people
- Sponsor
- PolyPid Ltd.
Surgical Site Infection
Irrisept Versus Standard of Care in the Prevention of Surgical Site Infections
The purpose of this study was to compare the rate of surgical site infections in patients randomized to Irrisept versus SoC, who had an open abdominal laparotomy for abdominal trauma or acute surgical abdomen.
- Trial name
- NCT02255487
- Testing
- IrriSept System, No Intervention - Standard of Care (SoC) only
- Where
- 17 sites in United States
- Volunteers
- 627 people
- Sponsor
- Irrimax Corporation
Surgical Site Infection, Colon Surgery
D-PLEX 312 - Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection (SHIELD II)
Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to Assess Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SoC), Compared to a SoC Treated…
- Conditions
- Surgical Site Infection, Colon Surgery, Abdominal Surgery, Post-Op Infection
- Trial name
- D-PLEX312 (NCT04411199)
- Testing
- D-PLEX, Standard of Care (SoC)
- Where
- 58 sites in United States, Bosnia and Herzegovina and 11 more
- Volunteers
- 975 people
- Sponsor
- PolyPid Ltd.
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
Postoperative Wound Infection-deep, Post Operative Wound Infection
A Phase I/II Double-Blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of RUT058-60
This is a double-blind, randomized, parallel-group, controlled, multi-center study to evaluate the safety and efficacy of RUT058-60 (Group A) as an intra-cavity lavage compared to sterile saline (Group B) in adult subjects…
- Trial name
- NCT02280395
- Testing
- RUT058-60, Sterile saline for irrigation
- Where
- 4 sites in United States
- Volunteers
- 9 people
- Sponsor
- Pulmatrix Inc.
Hernia, Abdominal, Abdominal Injuries
ENHANCE: A Prospective EvaluatioN of Permacol™ in tHe Repair of Complex AbdomiNal Wall CasEs
The objective of this prospective study is to evaluate short-term, mid-term, and long-term clinical outcomes associated with the use of Permacol™ Biological Implant in the treatment of complex abdominal wall defects
- Trial name
- ENHANCE (NCT01268514)
- Where
- 12 sites in Belgium, Germany and 3 more
- Volunteers
- 115 people
- Sponsor
- Medtronic - MITG
Acute Kidney Injury, Peritonitis
Phase 3 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury
Phase 3 multicenter study to be conducted in up to 90 qualified participating sites globally to assess the efficacy and safety of Reltecimod vs placebo in patients with sepsis-associated Stage 2/3 AKI.
- Conditions
- Acute Kidney Injury, Peritonitis, Necrotizing Soft Tissue Infection
- Trial name
- NCT03403751
- Testing
- Reltecimod 0.5 mg/kg
- Where
- 56 sites in United States, France
- Volunteers
- 58 people
- Sponsor
- Atox Bio Ltd
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.
Healthy, CVA
Development of Automated Analysis to Electroencephelogram (EEG) Data in Patients Treated at the Sagol Hyperbaric Medicine and Research Center at the Years 2017-2019.
DELPhI software developed for the analysis of EEG recordings in response to magnetic stimulation in relation to clinical data.
- Conditions
- Healthy, CVA, Hemorrhage, TBI (Traumatic Brain Injury)
- Trial name
- NCT04095377
- Testing
- No intervention, this is a retrospective study.
- Where
- Israel
- Volunteers
- 875 people, healthy volunteers welcome
- Sponsor
- QuantalX Neuroscience
Inguinal Hernia
PMCF Study of LiquiBand FIX8® OHMF Device
Study to evaluate the safety and performance of LiquiBand FIX8® Open Hernia Mesh Fixation Device.
- Trial name
- LBF8-Open (NCT04059640)
- Testing
- LiquiBand FIX8 Open Hernia Mesh Fixation Device
- Where
- 3 sites in United Kingdom
- Volunteers
- 109 people
- Sponsor
- Advanced Medical Solutions Ltd.