Clinical trials: Abdominal Injuries
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
Hernia, Ventral
Complex Ventral Hernia Repair Using Biologic or Synthetic Mesh
Hernias are often treated using a prosthetic mesh to add support to the healing wound. Prosthetic meshes have been used for decades to repair ventral hernias, level 1 data regarding which type of mesh to use is limited.
- Trial name
- CVHR (NCT02041494)
- Testing
- Ventralight, Strattice
- Where
- United States
- Volunteers
- 165 people
- Sponsor
- Hobart Harris
Wound Complication
Tissue Reinforcement of Incisional Closure Among High Risk Patients
Half of all individuals will undergo abdominal surgery in their lifetime. Following abdominal surgery, 30% of patients will suffer a major chronic complication with their wound closure in the first post-operative year.
- Trial name
- NCT03148496
- Testing
- Biologic Mesh, Small Bites, Large Bites
- Where
- 2 sites in United States
- Volunteers
- 163 people
- Sponsor
- The University of Texas Health Science Center, Houston
Postoperative Pain
TAP Block With Plain Bupivacaine Versus Wound Infiltration With Exparel for Postoperative Pain Management
In this randomized, controlled, observer-blinded study we plan to evaluate pain relief after ultrasound-guided transversus abdominis plane (TAP) block using bupivacaine and wound infiltration using liposomal bupivacaine in…
- Trial name
- NCT02074709
- Testing
- Plain bupivacaine, Liposomal bupivacaine
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Epithelial Ovarian Cancer, Fallopian Tube Carcinoma
Hyperthermic Intraoperative Intraperitoneal Chemotherapy of Recurrent Ovarian Cancer - A Feasibility Study
Most studies performing hyperthermic intraoperative intraperitoneal chemotherapy dose the cytotoxic drugs according to the body surface (like 50 mg/m² cisplatin) in analogy to systemic, intravenous chemotherapy (usually using the…
- Trial name
- NCT00968799
- Testing
- Hyperthermic intraoperative intraperitoneal chemotherapy, Cytoreduction, Cisplatin
- Where
- Switzerland
- Volunteers
- 6 people
- Sponsor
- Cantonal Hospital of St. Gallen
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.
Ventral Hernia
A Clinical Trial Using Spy Elite System in Planning Tissue Advancement Flaps After Ventral Hernia Repair
The purpose of this project is to assess the efficacy of the Spy Elite System (LifeCell Corporation, Branchburg, NJ, USA) in planning tissue advancement flaps and reducing wound complications after complex ventral hernia repairs.
- Trial name
- NCT01886963
- Testing
- SPY - Unblinded use of SPY Elite, Control - Blinded use of SPY Elite
- Where
- United States
- Volunteers
- 115 people
- Sponsor
- Wake Forest University Health Sciences
Adrenocortical Carcinoma, Peritoneal Carcinomatosis
Surgery and Heated Chemotherapy for Adrenocortical Carcinoma
Background: Adrenocortical carcinoma (ACC) is a rare tumor of the adrenal gland. Few people who develop this disease live more than 5 years after being diagnosed.
- Trial name
- NCT01833832
- Testing
- Cisplatin, Cytoreductive surgery, sodium thiosulfate
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- National Cancer Institute (NCI)
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.
Wound Healing Disorder, Impaired Wound Healing
Treatment Study of Vacuum Assisted Closure for Postsurgical Subcutaneous Abdominal Wound Healing Impairments
This clinical study is performed in several German, Dutch and Belgian hospitals to evaluate the efficacy of Vacuum Assisted Closure® (V.A.C.®) for the treatment of postsurgical abdominal wound healing impairments after surgery.
- Conditions
- Wound Healing Disorder, Impaired Wound Healing, Abdominal Wound Healing Disorder, Abdominal Wound Healing Impairment
- Trial name
- SAWHI (NCT01528033)
- Testing
- Vacuum Assisted Closure®, Standard conventional wound therapy
- Where
- 15 sites in Belgium, Germany
- Volunteers
- 539 people
- Sponsor
- University of Witten/Herdecke
High Risk Abdominal Wounds
Use of Negative Pressure Wound Therapy in High Risk Surgical Closed Incisions
The purpose of this study is to investigate the use of Negative Pressure Wound Therapy in high risk surgical wounds to evaluate the rate of surgical site infections (SSIs).
- Trial name
- NCT02137447
- Testing
- Negative Pressure treatment
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Massachusetts General Hospital
Hernia, Ventral Hernia
Prospective Clinical Evaluation of High-Purity Type I Collagen in Select High-Risk Hernia Repair Scenarios
This prospective, single-arm clinical study evaluates the safety, feasibility, and early clinical outcomes of High-Purity Type I Collagen (HPTC; Surgicoll-Mesh®) when used as a biologic reinforcement in selected hernia repair…
- Conditions
- Hernia, Ventral Hernia, Incisional Hernia, İnguinal Hernia
- Trial name
- NCT07360691
- Testing
- High-Purity Type I Collagen Mesh
- Where
- India
- Volunteers
- 30 people
- Sponsor
- Adichunchanagiri Institute of Medical Sciences, B G Nagara
Peritoneal Surface Malignancy, Postoperative Adhesion
SurgiPerito Trial: High-Purity Type-I Collagen for Peritoneal Reconstruction After Cytoreductive Surgery
This dual-centre, randomized controlled trial evaluates the safety and efficacy of high-purity Type-I collagen-based biomaterial, as a peritoneal substitute following peritonectomy in patients undergoing cytoreductive surgery…
- Conditions
- Peritoneal Surface Malignancy, Postoperative Adhesion, Bowel Obstruction, Wound Complications
- Trial name
- NCT07241091
- Testing
- High-Purity Type-I Collagen Scaffold, Standard Peritonectomy Closure
- Where
- 2 sites in India
- Volunteers
- 60 people
- Sponsor
- Adichunchanagiri Institute of Medical Sciences, B G Nagara
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
Bladder Injury, Complications; Cesarean Section
Cystoinflation to Prevent Bladder Injury in Obstetrics and Gynaecology Surgery
Part1:The healthy pregnant women with previous operative deliveries admitted for elective C-section will be counselled and conditioned informed consent will be taken to be included in either study group if dense pelvic adhesions…
- Conditions
- Bladder Injury, Complications; Cesarean Section, Adhesions Pelvic
- Trial name
- NCT04302545
- Testing
- Cystoinflation
- Where
- Pakistan
- Volunteers
- 564 people, healthy volunteers welcome
- Sponsor
- Shazia Saaqib
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
Gastrostomy
Transversus Abdominis Plane Block on Stress Response
This study evaluates the effect of transversus abdominis plane(TAP) block combined with general anesthesia on perioperative stress response in patients undergoing radical gastrectomy.
- Trial name
- NCT03035916
- Testing
- Transversus abdominis plane block, Epidural anesthesia, control
- Where
- China
- Volunteers
- 91 people
- Sponsor
- Jilin University