Clinical trials: Open Abdomen
Intra-operative Bleeding
Oxidized Cellulose hEmostAsis evaluatioN
The purpose of this study is to evaluate the safety and effectiveness of Traumastem to help stop bleeding in participants undergoing open cardiac, intra-abdominal (including retroperitoneal) and pelvic surgery as compared to…
- Trial name
- OCEAN (NCT01637025)
- Testing
- Oxidized cellulose strip, Oxidized regenerated cellulose strip
- Where
- 24 sites in Czechia, Germany and 2 more
- Volunteers
- 111 people
- Sponsor
- Baxter Healthcare Corporation
Infections, Pelvic Infections
An Investigational Agent for the Treatment of Complicated Intra-Abdominal Infections or Acute Pelvic Infections (0826-038)
The purpose of this study is to determine the effect of an approved medication for adults for an investigational use in pediatric patients 3 months to 17 years for the treatment of complicated intra-abdominal infections or acute…
- Trial name
- NCT00092170
- Testing
- MK0826, ertapenem sodium, Comparator: Ticarcillin/Clavulanate
- Volunteers
- 100 people
- Sponsor
- Merck Sharp & Dohme LLC
Urinary Tract Infections, Pyelonephritis Acute
Safety, Tolerability, and Pharmacokinetics of Sulopenem in Adolescents
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of intravenous sulopenem and oral sulopenem etzadroxil/probenecid in adolescent patients.
- Conditions
- Urinary Tract Infections, Pyelonephritis Acute, Intraabdominal Infections
- Trial name
- NCT04700787
- Testing
- Sulopenem
- Where
- United States
- Sponsor
- Iterum Therapeutics, International Limited
Analgesia
Pediatric Postoperative Analgesia Herniorrhaphy Study
This is a Phase 2 study in pediatric subjects undergoing inguinal herniorrhaphy.
- Trial name
- NCT03922048
- Testing
- HTX-011, Bupivacaine HCl, Luer Lock Applicator
- Sponsor
- Heron Therapeutics
Gram-Negative Bacterial Infections
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants
The primary purpose of this study is to understand the pharmacokinetics (PK) of single and multiple doses of cefiderocol in children from birth to less than 3 months of age with suspected or confirmed aerobic Gram-negative…
- Trial name
- NCT06086626
- Testing
- Cefiderocol, Standard of Care
- Where
- 4 sites in United States, South Africa and 1 more
- Volunteers
- 30 people
- Sponsor
- Shionogi
Neonatal Disorder
NIRS to Monitor Abdominal Tissue Oxygen Saturation in Preterm Infants
The NIRS (near infrared spectroscopy) sensor will be applied to the abdomen of the study population. To ensure good skin contact the sensor will be placed underneath the diaper.
- Trial name
- CTOM-FIH (NCT03706976)
- Testing
- Tissue Oxygenation Monitoring
- Where
- Switzerland
- Volunteers
- 12 people
- Sponsor
- Carag AG
Controlling Mild to Moderate Bleeding During Surgery
The EVARREST® Pediatric Mild or Moderate Liver and Soft Tissue Bleeding Study
The objective of this study is to evaluate the safety and hemostatic effectiveness of EVARREST as an adjunct to controlling mild to moderate soft hepatic parenchyma or soft tissue bleeding during open hepatic, abdominal, pelvic…
- Trial name
- NCT03255174
- Testing
- EVARREST® Fibrin Sealant Patch
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Ethicon, Inc.
Hemorrhage, Soft Tissue Bleeding
The EVARREST® Paediatric Mild/Moderate Liver and Soft Tissue Bleeding Study
The objective of this study is to evaluate the safety and effectiveness of EVARREST™ Sealant Matrix (EVARREST™ Fibrin Sealant Patch) (EVARREST™) in controlling mild or moderate soft tissue \& parenchymal bleeding during open…
- Conditions
- Hemorrhage, Soft Tissue Bleeding, Hepatic Parenchyma Bleeding
- Trial name
- NCT02227992
- Testing
- EVARREST™ Sealant Matrix, SURGICEL®
- Where
- 10 sites in Belgium, United Kingdom
- Volunteers
- 40 people
- Sponsor
- Ethicon, Inc.
Bacterial Infections, Intra-Abdominal Infection
Study Evaluating the Pharmacokinetics (PK), Safety, and Tolerability of Tigecycline in Patients 8 to 11 Years of Age
To determine the pharmacokinetic profile and to evaluate the safety and tolerability of ascending multiple doses of tigecycline in patients aged 8 to 11 years with selected serious infections; complicated intra-abdominal…
- Conditions
- Bacterial Infections, Intra-Abdominal Infection, Pneumonia, Bacterial, Skin Diseases, Bacterial
- Trial name
- NCT00488345
- Testing
- Tygacil
- Where
- 36 sites in United States, Belgium and 4 more
- Volunteers
- 59 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Infection
A Comparative Phase IV Study Evaluating Efficacy & Safety Of Magnex(Cefoperazone-Sulbactam) In Intraabdominal Infections
Intra-abdominal infections are often polymicrobial, and include aerobic as well as anaerobic bacteria. Antibiotics used in intra-abdominal infections should aim to cover organisms such as Enterobacteriaceae and Bacteroides…
- Trial name
- NCT00360607
- Testing
- Magnex (Sulbactam Sodium/Cefoperazone Sodium 1:1) Pfizer Ltd., Fortum (Ceftazidime for injection USP) Glaxo Smith Kline Pharmaceuticals Limited, Metrogyl (Metronidazole Injection IP) J.B.Chemicals & Pharmaceuticals Ltd.
- Where
- 20 sites in India
- Volunteers
- 307 people
- Sponsor
- Pfizer
Inguinal Hernia, Postoperative Pain
Safety, Tolerability, PK, and Analgesic Effect of INL-001 in Children Following Open Inguinal Hernia Repair
A multicenter, single-dose study in children 12 to <17 years of age, 6 to <12 years of age, and 2 to <6 years of age who are scheduled for elective open inguinal hernia repair.
- Trial name
- NCT03262688
- Testing
- Bupivacaine HCl collagen-matrix implant, Bupivacaine HCl infiltration
- Where
- 11 sites in United States
- Volunteers
- 159 people
- Sponsor
- Innocoll
Locally Resectable Pediatrics Tumors
CEB-01 in Pediatrics With Locally Resectable Abdominal Tumors
The CEB-01 implant is a membrane containing SN-38, the active metabolite of irinotecan, an already authorized chemotherapeutic agent.
- Trial name
- NCT06986811
- Testing
- Standard surgery, CEB-01
- Where
- Spain
- Volunteers
- 80 people
- Sponsor
- CEBIOTEX
Complicated Intra-abdominal Infections (cIAI)
A Study to Evaluate the Safety and Tolerability of Eravacycline in Pediatric Patients Aged 8 to 17 With Complicated Intra-abdominal Infections (cIAI)
A Phase 2 trial to assess safety, tolerability, and pharmacokinetics of eravacycline in pediatric patients aged 8 to <18 years with cIAI.
- Trial name
- NCT06794541
- Testing
- IV Eravacycline 2mg/kg, IV Eravacycline 1.5mg/kg
- Where
- 5 sites in United States
- Volunteers
- 35 people
- Sponsor
- Tetraphase Pharmaceuticals, Inc
Functional Gastrointestinal Disorders, Functional Abdominal Pain
Effect of 35624® Alflorex® in Functional Gastrointestinal Disorders (FGIDs) in Children.
The aim of this study is to evaluate the effect of supplementation with Bifidobacterium longum 35624® Alflorex® on frequency and severity of symptoms of abdominal pain using an adapted Irritable Bowel Symptom Severity Scoring…
- Trial name
- NCT04922476
- Testing
- Alflorex®
- Where
- Chile
- Volunteers
- 65 people
- Sponsor
- PrecisionBiotics Group Ltd.
TNF-receptor Associated Periodic Syndromes (TRAPS)
Efficacy and Safety Study of ACZ885 in Patients With Active Recurrent or Chronic TNF-receptor Associated Periodic Syndrome (TRAPS).
This trial will assess the safety and efficacy of ACZ885 in patients with active recurrent or chronic TNF-receptor associated periodic syndrome (TRAPS).
- Trial name
- NCT01242813
- Testing
- ACZ885
- Where
- 6 sites in Ireland, Italy and 1 more
- Volunteers
- 20 people
- Sponsor
- Novartis Pharmaceuticals
NEC
Sensing Oxygen Saturations Using Abdominal NIRS With an Investigational Realtime Device (Songbird)
Preterm infants are highly vulnerable and may suffer from multiple life-threatening conditions that manifest low tissue oxygenation (StO2).
- Trial name
- (Songbird) (NCT05278247)
- Testing
- NIRS
- Volunteers
- 50 people
- Sponsor
- Carag AG
Gram-negative Bacterial Infections, Bloodstream Infections (BSI)
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants
The primary objectives of this study are: To assess the safety and tolerability of cefiderocol after single-dose administration in hospitalized paediatric participants 3 months to < 18 years of age with suspected or confirmed…
- Conditions
- Gram-negative Bacterial Infections, Bloodstream Infections (BSI), Complicated Intra-abdominal Infection (cIAI), Hospital Acquired Pneumonia (HAP)
- Trial name
- NCT04335539
- Testing
- Cefiderocol, Standard of Care
- Where
- 23 sites in Belgium, Estonia and 7 more
- Volunteers
- 53 people
- Sponsor
- Shionogi