Clinical trials: Incisional Surgical Site Infections
Surgical Procedure, Unspecified
A Trial to Evaluate Negative Pressure Incision Management System for Groin Wounds in Vascular Surgery Patients
The purpose of this research study is to investigate if a new negative pressure incision (surgical cut) management system, could reduce the occurrence of groin wound infections after vascular surgery.
- Trial name
- NCT02399111
- Testing
- Prevena Incision Management System
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Northwell Health
Postoperative Wound Infection Deep Incisional Surgical Site, Prosthesis and Implants
Effect of Photodynamic Therapy on Skin Microbiome. Single Center Study (PHOMIC-II)
The overarching aim of this research project is to prevent orthopedic implant-associated infections. This study aims to investigate if PDT has an effect on bacterial skin colonization in order to improve skin antisepsis…
- Conditions
- Postoperative Wound Infection Deep Incisional Surgical Site, Prosthesis and Implants, Surgical Site Infection, Prosthetic Joint Infection
- Trial name
- NCT04618276
- Testing
- Photodynamic Therapy
- Where
- Switzerland
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Zurich
Surgery, Surgical Site Infection
SURGX Antimicrobial Gel Versus Povidone-iodine Skin Incision Prep in Total Shoulder Arthroplasty
Comparing the growth of intra-operative tissue cultures of Cutibacterium Acnes after primary shoulder replacement when using a no-prep control group versus antimicrobial wound gel versus betadine applied to the skin layer after…
- Conditions
- Surgery, Surgical Site Infection, Cutibacterium Acnes, Prosthetic-joint Infection
- Trial name
- NCT05919888
- Testing
- Povidone-Iodine, SURGX Wound Gel
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- St. Louis University
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.
Surgical Site Infection
Prevena™ Incisional Negative Pressure Wound Therapy in Re-operative Colorectal Surgery
Many strategies have been attempted to reduce SSI rates. The Centers for Medicare and Medicaid Services introduced the Surgical Care Improvement Project infection project with the aim of reducing SSI incidence and morbidity.
- Trial name
- NCT02509260
- Testing
- Prevena wound management system, Standard wound dressings
- Where
- United States
- Volunteers
- 298 people
- Sponsor
- The Cleveland Clinic
Surgical Wound Infection, Cesarean Section
Preventing Adverse Incisional Outcomes at Cesarean Multicenter Trial
The Prophylactic Negative Pressure Wound Therapy in Obese Women at Cesarean Trial is a large pragmatic multi-center randomized clinical trial designed to evaluate the effectiveness, safety and cost-effectiveness of prophylactic…
- Trial name
- Prevena-C (NCT03009110)
- Testing
- Prophylactic NPWT, Standard Dressing
- Where
- 6 sites in United States
- Volunteers
- 1,624 people, healthy volunteers welcome
- Sponsor
- Indiana University
Amputation, Amputation; Postoperative, Sequelae
Evaluation of Closed Incision Negative Pressure Dressing (PREVENA) to Prevent Lower Extremity Amputation Wound Complications
This study is a prospective, multi-center, two-arm, unblinded, and randomized controlled trial with a goal of evaluating the impact of a closed incision negative pressure dressing (PREVENA) on incidence of post-operative wound…
- Conditions
- Amputation, Amputation; Postoperative, Sequelae, Wound Dehiscence, Seroma
- Trial name
- PREVENA-AMP (NCT03773575)
- Testing
- PREVENA™ PEEL & PLACE™ Dressing Kit
- Where
- 3 sites in United States, Italy
- Volunteers
- 272 people
- Sponsor
- Thomas Jefferson University
Wound Infection, Surgical, Obesity
Surgical Application of Vac Dressings In Obese Patients to Reduce Wound Complications
The purpose of this study is to determine whether application of an incisional wound Prevena trademark (TM) dressing (applies negative pressure to wounds) in the obese (BMI ≥30) surgical patient will reduce surgical site…
- Conditions
- Wound Infection, Surgical, Obesity, Postoperative Complications
- Trial name
- SAVIOR (NCT02461433)
- Testing
- Prevena, Standard Dressing
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Johns Hopkins University
Infections
Study to Evaluate Efficacy and Safety of E-101 Solution for Preventing Surgical Site Infections After Colorectal Surgery
This study is intended to determine the efficacy, safety and tolerability of topical application of E-101 Solution directly into the surgical incisional wound in the prevention of infection of superficial and deep surgical…
- Trial name
- Triple IN (NCT01297959)
- Testing
- E-101 Solution 300 GU/ml, Saline solution
- Where
- 39 sites in United States, Israel
- Volunteers
- 503 people
- Sponsor
- Excited States, LLC
Peripheral Vascular Disease
Tele-Health Electronic Monitoring to Reduce Post Discharge Complications and Surgical Site Infections
Abstract: It is intuitive that post discharge surgical complications are associated with increased patient dissatisfaction, and directly associated with an increase in medical expenditures.
- Trial name
- THEM (NCT02767011)
- Testing
- Tele-Health Electronic Monitoring (THEM)
- Volunteers
- 30 people
- Sponsor
- CAMC Health System
Postoperative Wound Infection Superficial Incisional, Postoperative Wound Infection Deep Incisional Surgical Site
Safety and Efficacy of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery.
This study is aimed to assess the anti-infective efficacy of D-PLEX over a period of 3 months post operation as well as the safety over a period of 6 months, by preventing sternal infection post cardiac surgery in patients above…
- Trial name
- NCT02731573
- Testing
- D-PLEX, Open heart surgery
- Where
- 5 sites in Israel
- Volunteers
- 81 people
- Sponsor
- PolyPid Ltd.
Surgical Wound, Diabetes
EO2 Oxygen Delivery To Study Success Rate of Surgically Closed Wounds
The investigators will test the efficacy of the novel oxygen diffusion dressing allows delivery tissue oxygenation via TransCu O2® Oxygen Delivery System for use in caring for patients with surgically closed wounds.
- Conditions
- Surgical Wound, Diabetes, Amputation Wound, Incision Wound
- Trial name
- NCT03960463
- Testing
- Transcu O2®
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Baylor College of Medicine
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.
Surgical Site Occurences After Sternotomy, Wound Infection
The Use of PrevenaTM on Clean Closed Sternal Midline Incisions in Subjects at High Risk for Surgical Site Occurrences.
The purpose of this study is to compare the use of Prevena™ Incision Management System (IMS) versus standard wound care for the incision in subjects undergoing a sternal midline incision (sternotomy).
- Trial name
- NCT02195310
- Testing
- Prevena™ Incision Management System, Conventional sterile wound dressings
- Where
- 13 sites in Austria, Germany and 1 more
- Volunteers
- 342 people
- Sponsor
- Solventum US LLC
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.
Postoperative Wound Infection Deep Incisional Surgical Site, Prosthesis and Implants
Effect of Photodynamic Treatment on Skin Microbiome. Single Center Study
The overarching aim of this research project is to prevent orthopedic implant-associated infections. This study aims to investigate if photodynamic therapy has an effect on bacterial skin colonization and decrease number of…
- Conditions
- Postoperative Wound Infection Deep Incisional Surgical Site, Prosthesis and Implants, Surgical Site Infection, Prosthetic Joint Infection
- Trial name
- PHOMIC (NCT04067843)
- Testing
- Photodynamic treatment
- Where
- Switzerland
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Zurich
Complications; Cesarean Section, Surgical Wound Infection
Subcuticular Suture for Cesarean Skin Incision Closure
A comparison of the type of suture used for cesarean skin incision approximation and the subsequent rate of wound complications has not been widely studied.
- Trial name
- NCT02459093
- Testing
- poliglecaprone 25 suture, polyglactin 910 suture
- Where
- 2 sites in United States
- Volunteers
- 550 people
- Sponsor
- Montefiore Medical Center
Antibiotic Side Effect, Eyelid; Wound
Topical Antibiotic Prophylaxis for Eyelids
The investigators propose a prospective randomized control trial testing the hypothesis that routine topical antibiotic prophylaxis does not significantly reduce the rate of infection after eyelid surgery.
- Conditions
- Antibiotic Side Effect, Eyelid; Wound, Eyelid Diseases, Surgical Wound Infection
- Trial name
- NCT03199911
- Testing
- Topical Antibiotic Product, Topical Non-Antibiotic Ointment
- Where
- United States
- Volunteers
- 401 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Colorectal Surgery
Prospective, Randomized, Parallel-arm Clinical Trial of CleanCision or Alexis O in Elective Colorectal Surgery
Surgical site infection (SSI) remains a problem in colorectal surgery. Strategies to reduce the incidence of SSI following colorectal surgery are important to improve overall patient outcomes, reduce healthcare-associated costs…
- Trial name
- NCT03816995
- Testing
- CleanCision Wound Retraction and Protection System, Alexis O Wound Protector
- Where
- United States
- Volunteers
- 702 people
- Sponsor
- Scott Steele
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