Clinical trials: Negative Pressure Wound Therapy
Venous Leg Ulcers, Diabetic Foot Ulcers
Single-Use Negative Pressure Wound Therapy System vs. Traditional Negative Pressure Wound Therapy System (tNPWT)
The aim of this study is to compare the clinical efficacy of two types of NPWT systems; the traditional negative pressure wound therapy (tNPWT) system and the single-use negative pressure wound therapy (PICO) system.
- Trial name
- NPWT (NCT02470806)
- Testing
- PICO System, tNPWT System
- Where
- 17 sites in United States, Canada
- Volunteers
- 164 people
- Sponsor
- Smith & Nephew, Inc.
Frequency and Type of Medical Adhesive-Related Skin Injury, NPWT Drape Seal Effectiveness Rate (or Leak Incidence Rate)
Evaluation of a Switchable Acrylic Adhesive Drape for Safer Removal in Negative Pressure Wound Therapy Applications.
Negative pressure wound therapy (NPWT) is widely used for chronic and acute wounds, severe burns, and post-operative care. Despite its benefits, the strong adhesive required to maintain an airtight seal increases the risk of…
- Conditions
- Frequency and Type of Medical Adhesive-Related Skin Injury, NPWT Drape Seal Effectiveness Rate (or Leak Incidence Rate), Clinician Acceptability of New NPWT Drape, Patient Drop-out Rate From Prescribed NPWT Treatment
- Trial name
- NCT06717308
- Testing
- Comfort Release® NPWT drape
- Where
- 7 sites in United States
- Volunteers
- 300 people
- Sponsor
- Global Biomedical Technologies, LLC
Wounds and Injuries, Negative Pressure Therapy
Comparison of Wound Healing Between MedCu Dressings With Copper Oxide and Negative Pressure Wound Therapy Treatment
Randomized multisite two arms study in which one arm of patients will be treated with Negative Pressure Wound Therapy (NPWT) known also as Vacuum-assisted closure (VAC) treatment ("VAC Arm") and the second arm of patients will be…
- Conditions
- Wounds and Injuries, Negative Pressure Therapy, Diabetic Foot Ulcer
- Trial name
- NCT05215730
- Testing
- MedCu wound dressings with copper oxide (COD)
- Where
- Israel
- Volunteers
- 46 people
- Sponsor
- MedCu Technologies Ltd.
Diabetic Foot Ulcer
Clinical Evaluation of the Combined Use of Apligraf® and the SNaP® Pressure Wound Therapy System
The primary purpose of this study is to evaluate the safety and efficacy of the concurrent use of Apligraf® and the SNaP® Wound Care System for the treatment of diabetic and venous stasis lower extremity ulcers.
- Trial name
- OG/SNaP (NCT01623882)
- Sponsor
- KCI USA, Inc
Venous Leg Ulcer (VLU)
ConvaVAC™ Ag+ Negative Pressure Wound Therapy System in Chronic Wounds
Purpose of this study is to learn more about how safe and effective the ConvaVAC™ Ag+ wound therapy system is in treating certain types of long-lasting wounds, called chronic wounds.
- Trial name
- ConvaVAC VLU (NCT07342049)
- Testing
- ConvaVAC™ Ag+ Negative Pressure Wound Therapy System
- Where
- 7 sites in Chile, United Kingdom
- Volunteers
- 87 people
- Sponsor
- ConvaTec Inc.
Diabetic Foot Ulcer, Pressure Injury
A Dual-center Study Evaluating Clinical Acceptance of a NPWT Wound Care System
The purpose of this study is to determine if use of the Medela Invia Motion NPWT system supports acceptable progress towards the goal of therapy when treating patients with a variety of wound types during the evaluation period.
- Conditions
- Diabetic Foot Ulcer, Pressure Injury, Pressure Ulcer, Surgical Wound
- Trial name
- NCT04593693
- Testing
- Invia Motion Endure NPWT system
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- Medela AG
Acute Wound, Traumatic Wound
Confirm the Safety and Performance of Avance Solo NPWT System
The primary objective of this post market clinical follow-up (PMCF) investigation is to confirm safety and performance of Avance® Solo NPWT System in low to moderate exuding acute (traumatic wounds and flaps and grafts), as well…
- Conditions
- Acute Wound, Traumatic Wound, Skin Graft, Skin Flap
- Trial name
- ASOLO-SW (NCT04754048)
- Testing
- Avance Solo NPWT System
- Where
- 10 sites in Belgium, France and 2 more
- Volunteers
- 105 people
- Sponsor
- Molnlycke Health Care AB
Venous Leg Ulcer, Pressure Ulcer
Confirm Safety and Performance of Avance Solo and Avance Solo Adapt NPWT Systems
The primary objective of this post market clinical follow-up (PMCF) investigation is to confirm the safety and performance of Avance®Solo and Avance®Solo Adapt NPWT Systems in low to moderate exuding chronic wounds when used in…
- Conditions
- Venous Leg Ulcer, Pressure Ulcer, Diabetic Foot Ulcer, Chronic Ulcer
- Trial name
- ASOLO-CW (NCT04753294)
- Testing
- Avance Solo NPWT System, Avance Solo Adapt NPWT System
- Where
- 13 sites in Belgium, Denmark and 5 more
- Volunteers
- 136 people
- Sponsor
- Molnlycke Health Care AB
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
Ulcers, Wounds
SNaP Wound Care System Versus Traditional NPWT Device for Treatment of Chronic Wounds
The purpose of this study is to evaluate a novel negative pressure wound therapy (NPWT) device called the SNaP device compared to a traditional NPWT device for the treatment of lower extremity diabetic and venous ulcer wounds.
- Trial name
- NCT00951080
- Testing
- Traditional NPWT System, SNaP Wound Care System
- Where
- 17 sites in United States
- Volunteers
- 132 people
- Sponsor
- 3M
Soft Tissue Defects, Soft Tissue Wounds
Combined OFM and Vacuum-assisted Therapy for Expedited Regeneration Over Structures
Demonstrate faster tissue coverage of exposed structures using OFM in combination with negative pressure wound therapy (NPWT), versus NPWT alone
- Conditions
- Soft Tissue Defects, Soft Tissue Wounds, Traumatic Soft Tissue Defect
- Trial name
- COVER (NCT07385313)
- Testing
- Myriad™ applied in conjunction with NPWT, NPWT Alone
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Aroa Biosurgery Limited
Pressure Ulcers
Efficacy of Quantum NPWT With Simultaneous Irrigation on Reduction of Wound Volume in Stage III/IV Pressure Ulcers.
Negative-pressure wound therapy (NPWT) is an important adjunct for management of wounds, and promotes granulation tissue and angiogenesis.
- Trial name
- NCT01734109
- Testing
- Quantum Negative Pressure Wound Therapy Device
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Innovative Therapies, Inc.
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.
Esophagus Injury, Rectal Lesion
Suprasorb® CNPendo Used for Negative Pressure Therapy in the Oesophagus and Rectum to Support Defect and Wound Healing
A Post-Market Clinical Follow-up (PMCF) study designed as non-interventional, observational, prospective, multicentre study in a routine clinical care setting using a marketed medical device in line with the corresponding…
- Trial name
- Velox (NCT05476263)
- Where
- 7 sites in Germany
- Volunteers
- 110 people
- Sponsor
- Lohmann & Rauscher
Incision, Surgical, Surgical Incision
A Safety and Performance PMCF Investigation of the Avance® Solo NPWT System in Surgically Closed Incisions
The ASOLO-SCI investigation is a Post Market Clinical Follow-up (PMCF) study to investigate the safety and performance of the Avance® Solo NPWT System in treating low to moderate exuding surgically closed incisions for up to 14…
- Conditions
- Incision, Surgical, Surgical Incision, Surgical Wound, Surgical Wound, Recent
- Trial name
- ASOLO-SCI (NCT04894604)
- Testing
- Avance® Solo NPWT System
- Volunteers
- 34 people
- Sponsor
- Molnlycke Health Care AB
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.
Acute Non Infected Wounds, Non Infected Post Surgical Wounds
A Prospective, Open, Non-controlled Clinical Investigation to Evaluate a New Negative Pressure Wound Therapy (NPWT) System to be Used in the Treatment of Acute Non-infected Wounds and Post Surgical Infected Wounds
The investigation is designed as a prospective, open, non-controlled clinical investigation.
- Trial name
- NCT01195896
- Testing
- New NPWT system
- Where
- Germany
- Volunteers
- 9 people
- Sponsor
- Molnlycke Health Care AB
Chronic Wounds, Acute Wounds
A Clinical Study on New Negative Pressure Wound Therapy Dressing in the Management of Chronic & Acute Wounds
The purpose of the study is to evaluate the clinical performance of a new Negative Pressure Wound Therapy dressing in the management of chronic and acute wounds.
- Trial name
- NCT06306716
- Testing
- RENASYS Film with AIRLOCK Technology
- Where
- 2 sites in Canada, Puerto Rico
- Volunteers
- 7 people
- Sponsor
- Smith & Nephew, Inc.
Wound and Injuries, Surgical Wound Dehiscence
The Clinical Efficacy of RENASYS TOUCH NPWT System in the Management of Acute, Sub-acute and Chronic Wounds
The study is looking at the clinical efficacy, functionality and device performance of a new Negative Pressure Wound Therapy (NPWT) system in the management of a variety of wound types, in a real-life clinical setting.
- Trial name
- NPWT (NCT02565043)
- Testing
- RENASYS TOUCH Negative Pressure Wound Therapy System
- Where
- 2 sites in South Africa
- Volunteers
- 80 people
- Sponsor
- Smith & Nephew, Inc.
Surgical Wound, Recent, Surgical Wound Leak
Study of Avelle™ Negative Pressure Wound Therapy (NPWT) System
The main questions the study aims to answer are: How much do wounds improve when using the Avelle™ Negative Pressure Wound Therapy System for a maximum of 14 days? How safe is the Avelle™ Negative Pressure Wound Therapy System?
- Conditions
- Surgical Wound, Recent, Surgical Wound Leak, Dehiscence Wound, Trauma-related Wound
- Trial name
- NCT05805046
- Testing
- Negative Pressure Wound Therapy System
- Where
- 4 sites in United States
- Sponsor
- ConvaTec Inc.