Clinical trials: Incision, Surgical
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
Abscess, Wound Infection
Single Dose vs. Two Dose Regimen of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
To compare the efficacy of treatment with a single dose of dalbavancin 1500 mg to treatment with a two dose regimen of dalbavancin (1000 mg on Day 1 followed by 500 mg on Day 8) in participants with known or suspected…
- Conditions
- Abscess, Wound Infection, Surgical Site Infection, Cellulitis
- Trial name
- NCT02127970
- Testing
- Dalbavancin
- Where
- 78 sites in United States, Bulgaria and 10 more
- Volunteers
- 698 people
- Sponsor
- Durata Therapeutics Inc., an affiliate of Allergan plc
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.
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
Delayed Healing
PICO Breast Reduction Clinical Study Looking at Incision Healing Complications
The purpose of this study is to see if the use of a single-use negative pressure wound therapy system (NPWT) will have an effect on the reduction of post-surgical incision healing complications following breast reduction surgery…
- Trial name
- NCT01640366
- Testing
- PICO
- Where
- 6 sites in United States, France and 2 more
- Volunteers
- 200 people
- Sponsor
- Smith & Nephew, Inc.
Incisional Hernia
Xen Matrix™ AB Surgical Graft in Ventral or Incisional Midline Hernias
This study aims to prospectively explore the use of XenMatrix™ AB Surgical Graft for ventral or incisional midline hernia repair in patients across all wound classes ("All Comers") through 24 months post repair.
- Trial name
- NCT02691962
- Testing
- Xen Matrix AB
- Where
- 11 sites in United States
- Volunteers
- 75 people
- Sponsor
- C. R. Bard
Stress Urinary Incontinence
Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence
The aim of this postmarket study is to compare the safety and effectiveness of the Altis Single Incision Sling (SIS) to an FDA cleared transobturator and/or retropubic sling through 36 months.
- Trial name
- NCT02348112
- Testing
- Altis Single Incision Sling, Transobturator or Retropubic Sling
- Where
- 27 sites in United States, Canada
- Volunteers
- 416 people
- Sponsor
- Coloplast A/S
Gallbladder Disease
SILS™ Port Laparoscopic Cholecystectomy Post Market Study
The objectives of this trial are: 1. to assess the feasibility and safety of performing SILS™ Port Laparoscopic Cholecystectomy 2.
- Trial name
- NCT00832767
- Testing
- SILS™ port laparoscopic cholecystectomy, Four Port Laparoscopic Cholecystectomy
- Where
- 10 sites in United States, Italy and 1 more
- Volunteers
- 202 people
- Sponsor
- Medtronic - MITG
Cataracts
Clinical Investigation of Corneal Incision Size After Intraocular Lens (IOL) Implantation
The purpose of this study is to compare corneal incision size after IOL implantation with the use of one of four IOL delivery systems (three preloaded IOL delivery systems and one manually loaded IOL delivery system).
- Trial name
- NCT02826421
- Testing
- UltraSert Preloaded Delivery System, iTec Preloaded Delivery System, iSert Preloaded Delivery System
- Volunteers
- 114 people
- Sponsor
- Alcon Research
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 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
Scar Prevention
Safety and Efficacy Study of Different Dose Levels 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
- NCT01038297
- Testing
- EXC 001
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pfizer
Wounds and Injuries, Lacerations
A Clinical Study to Compare MAR-CUTIS With Dermabond Advanced
This was a randomized, open-label, multicenter, comparator-controlled clinical study to compare MAR-CUTIS with Dermabond Advanced in closure of surgical incisions and lacerations less than or equal to (<=)15 centimeter (cm).
- Conditions
- Wounds and Injuries, Lacerations, Surgical Incision
- Trial name
- NCT03688880
- Testing
- MAR-CUTIS, Dermabond Advanced
- Where
- 19 sites in France, Germany and 2 more
- Volunteers
- 107 people
- Sponsor
- Grünenthal GmbH
Full-thickness Skin Defects, Degloving Injuries
RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction
A prospective randomized within-subject controlled study to compare the clinical performance of conventional autografting with and without the RECELL system on acute non-burn full-thickness skin defects.
- Conditions
- Full-thickness Skin Defects, Degloving Injuries, Crush Injuries, Laceration of Skin
- Trial name
- NCT04091672
- Testing
- Control Intervention (Conventional Autograft), Investigational Intervention (RECELL + more widely meshed autograft)
- Where
- 18 sites in United States
- Volunteers
- 65 people
- Sponsor
- Avita Medical
Surgical Wound
AMBULATE: Cardiva Mid-Bore VVCS vs. Manual Compression for Multiple Femoral Venous Access Sites, 6 - 12F ID
The objective of the trial is to demonstrate the safety and effectiveness of the Cardiva Mid-Bore Venous Vascular Closure System (VVCS) in sealing femoral venous access sites and providing reduced times to ambulation (TTA)…
- Trial name
- NCT03193021
- Testing
- Cardiva Mid-Bore VVCS, Manual compression
- Where
- 13 sites in United States
- Volunteers
- 204 people
- Sponsor
- Cardiva Medical, 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
Surgical Wound, Bilateral Total Knee Arthroplasty
Evaluating Edema and Range of Motion Using Negative Pressure Therapy vs. Standard Surgical Dressing in Bilateral TKA
This study will compare the effects of closed incision negative pressure dressing vs. standard of care silver dressing on lower limb swelling after bilateral primary total knee arthroplasty.
- Conditions
- Surgical Wound, Bilateral Total Knee Arthroplasty, Wounds and Injuries, Joint Diseases
- Trial name
- ENABLE (NCT04712019)
- Testing
- Closed Incision Negative Pressure Therapy (ciNPT), Standard Silver-containing Dressing
- Where
- 6 sites in United States
- Volunteers
- 10 people
- Sponsor
- Solventum US LLC
Wound Heal
Safety of Microporous Annealed Particle (MAP) Wound Matrix in Patients With Clean Surgical Wounds.
A randomized, open-label, investigational safety evaluation of the Microporous Annealed Particle (MAP) Wound Matrix (TT101) device as a volumetric biomaterial scaffold applied to clean wounds after skin cancer surgery with Mohs…
- Trial name
- MOSAIC (NCT06600152)
- Testing
- MAP Wound Matrix, DuoDerm
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Tempo Therapeutics
Surgical Site Infection
Perioperative Patient Skin Antiseptic Preparation Evaluation
This study will evaluate a new topical skin antiseptic perioperative preparation and the standard of care to determine efficacy on the rates of surgical site infections of surgical patients. Safety will also be assessed.
- Trial name
- NCT04756804
- Testing
- 70% v/v Isopropyl Alcohol Surgical Solution, 2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol
- Where
- United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Zurex Pharma, Inc.
Sutures
A Study of Two Types of Absorbable Surgical Sutures in the Suturing of Thyroid Surgery Incision
The primary objective of this study is to evaluate the efficacy and safety of two types of absorbable surgical sutures -- STRATAFIX Spiral PDS Knotless Plus Tissue Control Device and STRATAFIX Spiral MONOCRYL Plus Knotless Tissue…
- Trial name
- Nautilus (NCT03792737)
- Testing
- Spiral PDS Plus, Spiral MONOCRYL Plus, PDS Plus
- Where
- 10 sites in China
- Volunteers
- 501 people
- Sponsor
- Ethicon, Inc.