Clinical trials: Surgical Incision
Surgical Site Infection
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
The aim of the study is to elucidate, if the colonization of bacteria is lower on the Novosyn® CHD suture compared to uncoated Polyglactin 910 suture, which will be assessed by the incidence of surgical site infections (SSI: A1…
- Trial name
- POLYNOVO-CHD (NCT05966961)
- Testing
- Novosyn® in emergency or elective laparotomy or laparoscopic surgery, Polyglactin 910 in emergency or elective laparotomy or laparoscopic surgery
- Where
- 4 sites in Italy, Spain
- Volunteers
- 2,998 people
- Sponsor
- Aesculap AG
Endophthalmitis
OTX-14-002: Device Exposure Registry
The objective of the study is to collect post-approval data relative to the incidence of endophthalmitis for cataract surgery patients treated with the FDA-approved ReSure Sealant when used by a broad group of physicians under…
- Trial name
- NCT02309736
- Testing
- ReSure Sealant
- Sponsor
- Ocular Therapeutix, Inc.
Wound Closure, Dehisced Surgical Wounds
Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives
surgical adhesive systems are used to close surgical cuts and simple skin wounds. This system is a non-invasive option, meaning it can be used instead of stitches or staples.
- Trial name
- NCT07613892
- Testing
- Evaluating wound closure products to close larger surgical site incisions, Evaluating wound closure products to close smaller surgical site incisions
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Medline Industries
Cataract, Astigmatism
Astigmatism Correction With Intrastromal Arcuate Incisions in Eyes Undergoing Cataract Surgery With Femtosecond Laser Using the Cassini Ambient With Iris Registration (ARCUATAS)
This is an observational, prospective follow-up post-marketing study of CE marked medical devices aimed at treating astigmatism in patients with cataracts.
- Trial name
- ARCUATAS (NCT05053620)
- Testing
- Calculation of the arcuate intrasomal incisions
- Where
- Spain
- Volunteers
- 22 people
- Sponsor
- OFTALVIST (Oftalmología Vistahermosa S.L)
Macromastia
Study of Prineo (Dermabond Protape) Versus Sutures in Breast Procedures
This is a prospective, controlled, randomized, multi-center clinical study of up to 80 patients with full thickness surgical incisions associated with bi-lateral breast procedures.
- Trial name
- NCT00558246
- Testing
- Dermabond Protape (Prineo), Suture
- Where
- 5 sites in Belgium, Germany and 2 more
- Volunteers
- 79 people
- Sponsor
- Ethicon, Inc.
Cataract
Phaco Versus Small Incision Cataract Surgery (SICS) Health Economic Study
To compare the health economic parameter and clinical outcome of Phacoemulsification with small incision cataract surgery (SICS)
- Trial name
- NCT00762606
- Testing
- Phacoemulsification cataract extraction surgery, Small incision cataract surgery
- Where
- United States
- Volunteers
- 106 people
- Sponsor
- Alcon Research
Stress Urinary Incontinence
The Altis® Single Incision Sling System for Female Stress Urinary Incontinence Study
An international, multi-center, single arm, prospective clinical study designed to assess the safety and efficacy of the Coloplast Altis single incision sling system for females with stress urinary incontinence (SUI).
- Trial name
- NCT01272284
- Testing
- Altis® Single Incision Sling System (SIS)
- Where
- 17 sites in United States, Canada
- Volunteers
- 113 people
- Sponsor
- Coloplast A/S
Contusions, Incision
Dermal Wound Closure Using Silkam®
Assessment of performance of Silkam® suture material for skin closure. A prospective, single center, single arm, observational study in daily practice.
- Conditions
- Contusions, Incision, Laceration
- Trial name
- DERMASILK (NCT05225714)
- Where
- Spain
- Volunteers
- 161 people
- Sponsor
- Aesculap AG
Surgical Site Reaction
The Use of the Prevena Incision Management System (PIMS) on Closed Incisions in Renal Transplant Subjects
This study is being conducted to see how safe and effective the Prevena Incision Management System "Prevena" is when placed over a renal transplantation incision. Prevena provides negative pressure (suction) wound therapy.
- Trial name
- PIMS (NCT01341444)
- Testing
- Prevena Incision Management System, Standard of Care for Surgical Incisions
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- KCI USA, Inc
Surgical Site Infections, Surgical Wound Infection
Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections
This is a Phase 3 multi-center, group-randomized, crossover trial to compare nasal antimicrobial photodisinfection therapy (aPDT) with standard of care for prevention of surgical site infections in patients undergoing major…
- Conditions
- Surgical Site Infections, Surgical Wound Infection, Infections, Anti-Infective Agents
- Trial name
- LANTERN (NCT06702878)
- Testing
- nasal antimicrobial photodisinfection therapy
- Where
- 14 sites in United States
- Volunteers
- 4,787 people
- Sponsor
- Ondine Biomedical Inc.
Cholecystectomy, Benign Hysterectomy
Post Market Study for FloShield 10mm Reusable Cannula and Blunt Obturator and Robotic FloShield
This study evaluates the use of the FloShield System with the FloShield 10mm reusable Cannula and Oburator during standard robotic laparoscopic single-site surgery.
- Conditions
- Cholecystectomy, Benign Hysterectomy, Salingo-oophorectomy
- Trial name
- NCT02163239
- Testing
- Cannula and Blunt Obturator
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Minimally Invasive Devices, Inc.
Surgical Wound
VASCADE ANTEGRADE-PVD Post-Market Registry
The objective of the registry is to collect procedural outcomes data when the Cardiva VASCADE Vascular Closure System (VCS) is used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional…
- Trial name
- NCT02948257
- Testing
- Cardiva Medical VASCADE VCS
- Where
- 5 sites in United States
- Volunteers
- 52 people
- Sponsor
- Cardiva Medical, Inc.
Scar Prevention
Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars in Subjects Undergoing Elective Abdominoplasty
This study will compare how well EXC 001 works versus placebo in reducing the appearance of scars in subjects undergoing elective abdominoplasty. The study will also evaluate the safety of EXC 001 in healthy adult subjects.
- Trial name
- NCT01037985
- Testing
- EXC 001
- Where
- 6 sites in United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Pfizer
Linear or Emi-linear Incisions, Total Hip Arthroplasty
Prevena™ Incision Management System Over Primarily Closed Hip and Knee Incisions in Patients Immediately Post Total Hip and Knee Arthroplasty
The intent of this study is to evaluate the Prevena ™ 125 Unit and dressing system, when applied to either the hip or knee area over a surgical cut for the time you are hospitalized.
- Conditions
- Linear or Emi-linear Incisions, Total Hip Arthroplasty, Total Knee Arthroplasty
- Trial name
- Prevena2009-45 (NCT01380665)
- Testing
- Prevena Incisional Management System
- Sponsor
- KCI USA, Inc
Diabetic Foot Ulcer, Surgical Wound
The Effect of Natrox® Oxygen Wound Therapy on the Healing Rate of Chronic Diabetic Foot Ulcers
A Multicentre Randomized Controlled Trial to Investigate the Effect of Natrox Topical Oxygen Wound Therapy on the Healing rates of Diabetic Foot Ulcers.
- Trial name
- NCT03905863
- Testing
- Natrox® Oxygen Wound Therapy
- Where
- 20 sites in United States, Puerto Rico
- Volunteers
- 145 people
- Sponsor
- Inotec AMD Limited
Colorectal Surgery, Surgical Wound Infection
A Study of an Antibiotic Implant in General Surgical Subjects at Higher Risk for Surgical Wound Infection
The purpose of this study is to determine whether the gentamicin-collagen sponge is safe and effective for preventing surgical wound infections in patients undergoing colorectal surgery.
- Trial name
- NCT00600925
- Testing
- gentamicin-collagen sponge dipped in saline
- Where
- 39 sites in United States
- Volunteers
- 602 people
- Sponsor
- Innocoll
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
Post-surgical Oral Wounds, Oral Cavity Surgery
Evaluation of the Performance and Safety of a Linear Hyaluronic Acid-Based Medical Device in the Treatment of Surgical Wounds in the Oral Cavity.
The PR-DENT study is an interventional, single-center, controlled clinical investigation aimed at evaluating the clinical performance and safety of a Class III medical device based on linear hyaluronic acid for the treatment of…
- Conditions
- Post-surgical Oral Wounds, Oral Cavity Surgery, Wound Healing/Regeneration, Dental Extraction Sites
- Trial name
- PR-DENT (NCT07421934)
- Testing
- Intervention: Linear Hyaluronic Acid (Gumblast), Control: Standard Surgical Procedure
- Where
- Italy
- Volunteers
- 28 people
- Sponsor
- The Wave Innovation Group s.r.l.
Child Delivery Using an Elective C- Section
Evaluation of the BioWeld1 System as a Method for Surgical Incision Closure
The purpose of this study is to assess the safety and performance of the BioWeld1 System procedure for surgical incision closure of the skin in women scheduled for elective C-section procedure.
- Trial name
- NCT01709240
- Testing
- BioWeld1 System
- Where
- Israel
- Sponsor
- IonMed Ltd
Bacterial Infections
Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.
- Trial name
- cSSSI (NCT00424190)
- Testing
- IV Vancomycin plus IV Aztreonam, Ceftaroline
- Where
- 52 sites in United States, Argentina and 9 more
- Volunteers
- 698 people
- Sponsor
- Forest Laboratories