Clinical trials: Abdominal Trauma
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.
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
Open Abdomen
Post Market Clinical Follow Up Study of Avance Foam Abdominal Dressing Kit in Open Abdomen
The investigation is a Post Marketing Follow-Up Study for the Avance Foam Abdominal Dressing Kit conducted as part of Mölnlycke Health Care's quality system.
- Trial name
- NCT01968811
- Testing
- Avance Foam dressing kit
- Where
- Sweden
- Volunteers
- 10 people
- Sponsor
- Molnlycke Health Care AB
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
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.
Hernia, Surgical Wound Dehiscence
Repair of Challenging Abdominal Wall Defects: Strattice(TM) TM in Abdominal Wall Repair (StAR)
The objective of this study is to compare the incidence of post-repair wound related complications, including hernia occurrence/recurrence, between challenging abdominal wall defects repaired with Strattice(TM) Reconstructive…
- Trial name
- StAR (NCT01083472)
- Testing
- Strattice(TM) Reconstructive Tissue Matrix, Suture/suture with absorbable mesh
- Where
- 29 sites in France, Germany and 4 more
- Volunteers
- 37 people
- Sponsor
- LifeCell
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 Wound Infection, Postoperative Wound Infection
Study Evaluating Severe Surgical Site Infections (SSIs) Following Contaminated Or Dirty-infected Abdominal Surgery
This is an observational study to evaluate the relative importance of the known risk factors for severe surgical site infections (SSIs) on the development of the more severe SSI cases, and to describe the demographic, clinical…
- Trial name
- EURIDICE (NCT00906074)
- Testing
- Elective or emergency abdominal surgery
- Volunteers
- 180 people
- Sponsor
- Pfizer
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
Wound Healing and Prevention
Performance, Safety and Efficacy of NPWT Device
Smith \& Nephew are assessing a new investigational single use NPWT system.
- Trial name
- NCT04102865
- Testing
- Negative-Pressure Wound Therapy (NPWT)
- Where
- 8 sites in United Kingdom
- Volunteers
- 90 people
- Sponsor
- Smith & Nephew, Inc.
Surgical Site Infections
Safety, Efficacy and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal Surgery
This is a randomized, blinded, placebo and standard of care controlled study of the efficacy of a novel antibiotic containing gel compared to placebo gel in preventing surgical site infection after abdominal surgery.
- Trial name
- NCT01888367
- Testing
- DFA-02 Antibiotic Gel
- Where
- 31 sites in United States
- Volunteers
- 445 people
- Sponsor
- Dr. Reddy's Laboratories Limited
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