Clinical trials: Abdominal Trauma
Laparotomy, Incisional Hernia
Clinical Performance and Safety of Suture-TOOL
The goal of this single arm intervention study is to investigate the safety and performance of a suturing device for closure of the midline incision after open abdominal surgery.
- Conditions
- Laparotomy, Incisional Hernia, Wound Infection, Closure Technique
- Trial name
- NCT05695157
- Testing
- Suture-TOOL
- Where
- Sweden
- Volunteers
- 38 people
- Sponsor
- Suturion AB
Wound Healing, Abdominal Surgery
Management of Abdominal Post-surgical Scar With Ozoaqua Versus Standard Care
A prospective, randomized clinical study with a blinded evaluator to compare a post-surgical abdominal scar care protocol using Ozoaqua products versus standard care in patients undergoing open abdominal surgery.
- Conditions
- Wound Healing, Abdominal Surgery, Scar Improvement
- Trial name
- NCT07678372
- Testing
- Ozonated product-based protocol for scar hygiene and care
- Where
- 2 sites in Spain
- Volunteers
- 144 people
- Sponsor
- Laboratorios Ozoaqua
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
Tissue Repair, Soft Tissue Reconstruction
Urinary Bladder Matrix (UBM) Registry
The purpose of this registry is to collect real-world information on patients treated with Urinary Bladder Matrix (UBM) products.
- Conditions
- Tissue Repair, Soft Tissue Reconstruction, Wound Management, Pressure Ulcer (PU)
- Trial name
- NCT07805798
- Testing
- Urinary Bladder Matrix (UBM) Products
- Volunteers
- 300 people
- Sponsor
- Integra LifeSciences 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.
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
Intraabdominal Hypertension, Abdominal Compartment Syndrome
Physiologic Signals and Signatures With the Accuryn Monitoring System - The Accuryn Registry
The Accuryn Registry Study is an open-ended, global, multi-center, retrospective and prospective, single-arm data collection study with an FDA cleared device. The target population are cardiovascular surgery patients.
- Conditions
- Intraabdominal Hypertension, Abdominal Compartment Syndrome, Acute Kidney Injury, Cardiovascular Surgery
- Trial name
- NCT04669548
- Testing
- Accuryn Monitoring System
- Where
- 9 sites in United States
- Volunteers
- 2,500 people
- Sponsor
- Potrero Medical
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.
Critical Illness, Acute Kidney Injury
Collective Accuryn Physiologic Signals and Signatures
The CAPSS Study is a retrospective and prospective, multi-center, single-arm post-market data collection study with an FDA cleared device.
- Conditions
- Critical Illness, Acute Kidney Injury, Sepsis, Septic Shock
- Trial name
- CAPSS (NCT03817281)
- Testing
- Accuryn Monitoring System
- Where
- United States
- Sponsor
- Potrero Medical
Acute Kidney Injury, Septic Shock
Targeting Abdominal Perfusion Pressure in Septic Shock
A randomized control trial among patients with septic shock, studying the incidence, progression and recovery of AKI.
- Conditions
- Acute Kidney Injury, Septic Shock, Resuscitations
- Trial name
- MAP-APP (NCT03582046)
- Testing
- Abdominal Perfusion Pressure (APP), Mean Arterial Pressure (MAP)
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- Potrero Medical
Injury of Abdominal Wall
Effect of Stitch Technique on the Occurrence of Incisional Hernia After Abdominal Wall Closure
The major long term complication of abdominal wall closure after a median laparotomy is the development of an incisional hernia.
- Trial name
- ESTOIH (NCT01965249)
- Testing
- Long stitch, Short Stitch
- Where
- 9 sites in Austria, Germany
- Volunteers
- 425 people
- Sponsor
- Aesculap AG
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
Acute Kidney Injury, Abdominal Compartment Syndrome
Physiologic Signals and Signatures With the Accuryn Monitoring System (The Accuryn Registry)
The Accuryn Registry Study is an open-ended, global, multi-center, retrospective and prospective, single-arm data collection study with an FDA cleared device. The target population are cardiovascular surgery patients.
- Conditions
- Acute Kidney Injury, Abdominal Compartment Syndrome, Intraabdominal Hypertension, Cardiovascular Surgery
- Trial name
- NCT04585555
- Testing
- Accuryn Monitoring System
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Potrero Medical
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