Clinical trials: Negative Pressure Therapy
Chronic Ulcers: Non-healing Deep Cavity Wounds (e.g., Diabetic Foot Ulcers, Arterial Ulcers, Post-surgical Wound Healing Disorders)
INJECTHEAL - Investigation of Chronic Wound Exudate and Biofilm
This prospective observational study will collect routine clinical waste material from 72 adults with chronic, non-healing wounds, including wound exudate from negative pressure therapy containers or sponges and wound…
- Trial name
- INJECTHEAL (NCT07745764)
- Testing
- standard of care
- Where
- Germany
- Volunteers
- 72 people
- Sponsor
- Barbara Wolff-Winiski
Root Canal Infection
Effect of Apical Negative Pressure Irrigation System at Cleaning Lateral Canals and Reduction of Periapical Lesions After Endodontic Therapy
The aim of the present study is to assess with PA x-rays and CBCT scans the volumetric changes in periapical radiolucencies in endodontically treated teeth 1 year after endodontic treatment and evaluate how well the lateral…
- Trial name
- NCT03384004
- Testing
- Irrigation Technique 1, Irrigation Technique 2
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- KaVo Kerr
Obstructive Sleep Apnea
Variable Negative External Pressure (vNEP) - An Alternative to Continuous Positive Airway Pressure (CPAP) for the Treatment of Obstructive Sleep Apnea (OSA): A Pilot Study
Non-compliance rates estimated at 50% pose a major issue for CPAP therapy, the primary treatment for OSA. Negative external pressure, applied over the anterior neck under the mandible, has shown encouraging results as an…
- Trial name
- NCT04718142
- Testing
- vNEP
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Somne, LLC
Diabetic Amputation Foot Wound
A Study Comparing V.A.C. Negative Pressure Wound Therapy (NPWT) to Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Amputation Wounds
The objective of this study is to thoroughly examine the role of V.A.C. NPWT in the further salvage of the diabetic foot once it has undergone partial amputation.
- Trial name
- VAC 2006-19 (NCT00837096)
- Testing
- V.A.C. Therapy, Moist wound therapy (MWT)
- Volunteers
- 19 people
- Sponsor
- KCI USA, Inc
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.
Snoring
Continuous Negative External Pressure for the Treatment of Primary Snoring
The aim of this pilot study is to gain information on the ability of a continuous negative external pressure collar to safely reduce snoring in primary snorers, and if so to determine whether the reduction in snoring has benefits…
- Trial name
- NCT03372070
- Testing
- cNEP
- Where
- United States
- Sponsor
- Sommetrics, Inc.
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
Wounds and Injuries, Wound Healing
Negative Pressure Wound Therapy With Instillation of Saline Solution Versus Collagenase Ointment in Full-thickness Wounds
Evaluation of wound bed surface area containing clean, healthy viable tissue in full-thickness wounds.
- Conditions
- Wounds and Injuries, Wound Healing, Granulation Tissue
- Trial name
- ACCELERATE (NCT03722485)
- Testing
- Negative Pressure Therapy w/ instillation and dwell (NPWTi-d), Collagenase Ointment
- Where
- 10 sites in United States
- Volunteers
- 44 people
- Sponsor
- KCI USA, Inc
Skin Reaction to Mechanical, Thermal and Radiation Stimuli, Skin Sensitisation
Study Comparing iNPWT Dressing and Devices Affect on Bioburden Levels and Skin Condition After Seven Days
Incisional dressings aim to prevent contamination of an incisional wound and protect against skin irritation. Surgeons use incisional negative pressure wound therapy (iNPWT) to manage incisional wounds.
- Trial name
- HHiNPWT7DC (NCT05559697)
- Testing
- Sponsor incisional negative pressure wound therapy device and dressing, Standard of Care incisional negative pressure wound therapy system
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- DeRoyal Industries, Inc.
Obstructive Sleep Apnea (OSA)
A Post-marketing Surveillance of the Negative Pressure Sleep Therapy System to Treat Obstructive Sleep Apnea
This is a post-marketing surveillance study to investigate the efficacy and safety of the Negative Pressure Sleep Therapy System for the treatment of obstructive sleep apnea.
- Trial name
- NCT02698059
- Testing
- iNAP® Sleep Therapy System (iNAP)
- Where
- 8 sites in Germany, Taiwan
- Volunteers
- 63 people
- Sponsor
- Somnics, Inc.
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
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
Surgical Incision, Ulcer Foot
Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds
This is a prospective, multi-center, open label study evaluating the performance of PICO14 Negative Pressure Wound Therapy (NPWT) in the management of chronic open wounds (pressure ulcers, venous leg ulcers, diabetes related foot…
- Conditions
- Surgical Incision, Ulcer Foot, Ulcer Venous, Ulcer, Leg
- Trial name
- PICO14 (NCT05234632)
- Testing
- PICO 14 single-use Negative Pressure Wound Therapy System
- Where
- 6 sites in Germany, United Kingdom
- Volunteers
- 45 people
- Sponsor
- Smith & Nephew, Inc.
Wounds and Injuries
Utilizing RENASYS◊ DYNAFLOW Instillation Therapy System for Wound Management in Adults With Acute and Chronic Wounds
The purpose of this study is to investigate the functional performance of the RENASYS◊ DYNAFLOW Instillation Therapy System for wound management in adults with acute and chronic wounds.
- Trial name
- NCT07899814
- Testing
- RENASYS◊ DYNAFLOW Instillation Therapy
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Smith & Nephew, Inc.
Oncoplastic Breast Surgery, Bilateral Surgery
A Clinical Study to Assess the Safety and Clinical Performance of a New Dressing (PICO7Y) in Breast Surgery Patients
The purpose of the study is to assess the use of a wound dressing system called PICO7Y following a two-sided breast surgery. PICO7Y is a new dressing system made to treat two incisions/wounds at the same time, and the purpose of…
- Trial name
- PICO7Y (NCT03835845)
- Testing
- PICO7Y
- Where
- 5 sites in Netherlands, United Kingdom
- Volunteers
- 40 people
- Sponsor
- Smith & Nephew, Inc.
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 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.
Surgical Wound
Regenn® Therapy System Safety Study
The goal of this clinical trial is to evaluate the safety of the investigational device, Regenn® Negative Pressure Therapy System (Regenn® Therapy), a form of Negative Pressure Wound Therapy (NPWT), in the post-operative surgical…
- Trial name
- NCT06259409
- Testing
- Regenn® Negative Pressure Therapy System, Prevena™ Incision Management System
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Progenerative Medical, Inc
Snoring
Pilot Study of cNEP for the Treatment of Snoring
This pilot study will examine the efficacy and safety of continuous negative external pressure ("cNEP") for the treatment of chronic snoring in people without obstructive sleep apnea.
- Trial name
- NCT02767843
- Testing
- continuous negative external pressure (cNEP)
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Sommetrics, Inc.
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