Clinical trials: Abdominal Injury
Open Abdomen
ABRA Abdominal Closure System in Open Abdomen Management
For the last 20 to 30 years, damage control laparotomy and decompressive laparotomy have emerged as part of the armamentariums for treatment of complex abdominal trauma, abdominal compartment syndrome, and critically ill surgical…
- Trial name
- ABRA (NCT00754156)
- Testing
- ABRA Abdominal Closure System, V.A.C. Therapy, KCI ABThera
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Anna Rockich
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
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
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
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 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.
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
SURGICAL SITE INFECTION
Early Short-term Antibiotic Therapy in Penetrating Abdominal Trauma, 3 vs 7 Days
Abdominal penetrating trauma represents a frequent cause of consult into emergency rooms in Venezuela. Accidents and violence at Hospital "Miguel Perez Carreño" along april 2009 were represented by gunshots and stabbing wounds…
- Trial name
- NCT01203046
- Testing
- Ertapenem
- Volunteers
- 56 people
- Sponsor
- Silvia M. Pinango L.
Gastrointestinal Injury, Complicated Diverticulitis
Vacuum Assisted Therapy in Emergent Contaminated Abdominal Surgeries
Emergent abdominal surgeries have very high rate of wound contamination due to exposure to bacteria from GI tract. There are several different approaches to wound management in these patients including wet-to-dry dressing or…
- Trial name
- NCT02127164
- Testing
- "Veraflo" device, Dakin's solution
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- University of Arizona
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
Contrast-Enhanced Ultrasound in the Evaluation of Abdominal Injuries in Children
This study proposes to evaluate the accuracy of contrast-enhanced ultrasound (CEUS) in diagnosing abdominal solid organ injuries in pediatric patients. 146 subjects will be enrolled across approximately 8 sites in the US.
- Trial name
- NCT03147690
- Testing
- Lumason
- Where
- 8 sites in United States
- Volunteers
- 74 people
- Sponsor
- David Mooney
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
Surgical Incision
Secondary Versus Tertiary Wound Closure in High Risk Gynecologic Abdominal Surgical Incisions
The purpose of this research study is to determine if closing a surgical wound differently is better than the procedure that is currently used.
- Trial name
- NCT03861065
- Testing
- Tertiary Wound Closure, Historical Wound Closure
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Wake Forest University Health Sciences
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
Open Wound Abdominal Wall, Wound Non Healing
Effect of Oasis® Wound Matrix on Stage III and IV Trunk Pressure Wounds Treated With Negative Pressure Wound Therapy
This study evaluates the therapeutic effect of Oasis® Matrix along with Negative Pressure Wound Therapy (NPWT) on pressure wounds. Either Oasis or standard foam will be applied to the wound prior to activating the NPWT.
- Trial name
- NCT02246608
- Testing
- NPWT Standard of Care plus Oasis wound product, Routine NPWT Standard of Care
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Kettering Health Network
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 Wound Dehiscence, Wound Infection
Prevention of Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy
Wound complications after Cesarean section (C-section) are common in obese women. Approximately 25% of obese women having a C-section will have a wound complication.
- Trial name
- NCT00654641
- Testing
- Negative pressure wound closure, Standard wound closure
- Where
- 2 sites in United States
- Volunteers
- 54 people
- Sponsor
- West Virginia University
Fistula, Abdominal Injury
Pilot Study Evaluating the Safety and Efficacy of a Patient-Specific Enteroatmospheric Fistula Isolation and Management Device Independent of Negative Pressure Wound Therapy
This study aims to assess the efficacy of a custom fitted device designed to isolate enteroatmospheric fistulas effluent independent of negative pressure wound therapy and to evaluate the effects on the device related to dressing…
- Conditions
- Fistula, Abdominal Injury, Negative Pressure Wound Therapy
- Trial name
- NCT04978090
- Testing
- 3D printed EAF management device
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Andrew Bernard
Open Abdomen, Abdominal Adhesions
Seprafilm in Open Abdomens: a Study of Wound and Adhesion Characteristics in Trauma Damage Control Patients
The goal of this study is to test the effects of Seprafilm adhesion barrier on patients who are undergoing open abdomen damage control management for traumatic injuries when compared to no adhesion barrier use.
- Conditions
- Open Abdomen, Abdominal Adhesions, Trauma, Wounds and Injury
- Trial name
- OASIT (NCT01594385)
- Testing
- Seprafilm
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Stan Stawicki
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