Clinical trials: Closed-Incision Negative Pressure Therapy
Breast Cancer
ciNPT in Autologous Abdominal Tissue Breast Reconstruction
In women who undergo mastectomy for the treatment of breast cancer, autologous reconstruction using the deep inferior epigastric perforator (DIEP) flap is a common surgical procedure that aims to restore both the appearance and…
- Trial name
- NCT04985552
- Testing
- DIEP Breast Reconstruction, ciNPT, Conventional Tape Dressings
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- McMaster University
Breast Reconstruction
Negative Pressure in PAP Donor Sites
A retrospective chart review will be conducted to identify patients who received breast reconstruction using free profunda artery perforator (PAP) flap by the investigators from January 2015 to August 2021.
- Trial name
- NCT05491473
- Testing
- Closed incisional negative pressure wound therapy (iNPWT) system
- Where
- Taiwan
- Volunteers
- 25 people
- Sponsor
- Chang Gung Memorial Hospital
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
Obesity, Lumbar Spine Surgery
WoundVac in Obese Patients Undergoing Lumbar Surgery
This is an open label, randomized clinical trial of Closed-Incision Negative-Pressure Therapy to decrease post-operative wound complications in patients with BMI ≥35kg/m2 after posterior lumbar spine surgery.
- Trial name
- NCT03688438
- Testing
- Closed-Incision Negative-Pressure Therapy
- Where
- United States
- Volunteers
- 124 people
- Sponsor
- Norton Leatherman Spine Center
Wound Heal, Periprosthetic Joint Infection
Closed Incisional Negative Pressure Wound Therapy in Post-surgical Wound Care of Patients With Periprosthetic Joint Infection
In the proposed study, we will apply Prevena on the surgical wound right after closure of the wound in the operating theater. Prevena will be used for 7 days, unless there is ongoing infection or much wound drainage that requires…
- Trial name
- NCT05357287
- Testing
- PREVENA incision management system
- Where
- Taiwan
- Volunteers
- 70 people
- Sponsor
- Chang Gung Memorial Hospital
Wound Infection, Peripheral Arterial Disease
A Randomized Clinical Trial Evaluating Negative Pressure Therapy to Decrease Vascular Groin Incision Complications
The purpose of this study is to determine if the application of a negative pressure dressing intraoperatively (Prevena; KCI, Inc) to vascular groin incisions decreases the wound complication rate in high risk patients.
- Conditions
- Wound Infection, Peripheral Arterial Disease, Aneurysm, Surgical Wound Dehiscence
- Trial name
- NCT02581904
- Testing
- Prevena Care, Dry gauze dressing care
- Where
- United States
- Volunteers
- 140 people
- Sponsor
- Thomas Jefferson University
Diabetes, Morbid Obesity
Closed Incision Negative Pressure Wound Therapy vs. Foam as Post Operative Dressing
The primary objective is to assess the frequency of a wound healing complication, in a closed incisional wound in a "high risk" surgical incision when treated with Negative Pressure Wound Therapy versus a highly absorbent…
- Conditions
- Diabetes, Morbid Obesity, Lymphedema, Orthopedic Disorder
- Trial name
- NCT05427916
- Testing
- Avance Solo, Optifoam
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Mastectomy, Breast Reconstruction
CiNPWT Using in Mastectomy Wound Care After DIEP Flaps for Breast Reconstruction
Background: Closed-incision negative pressure wound therapy (ciNPWT) is effective in reducing postoperative complications, yet its use in free flap breast reconstruction mastectomy wound remains controversial due to concerns that…
- Conditions
- Mastectomy, Breast Reconstruction, Closed-Incision Negative Pressure Therapy
- Trial name
- NCT07546968
- Testing
- Closed-Incision Negative Pressure Wound Therapy (CiNPWT)
- Where
- Taiwan
- Volunteers
- 253 people
- Sponsor
- Chiayi Christian Hospital
Surgical Wound Infection, Peripheral Vascular Diseases
Negative Pressure Wound Therapy for the Prevention of Surgical Site Infection Following Lower Limb Revascularization
The purpose of this study is to investigate the current standard of wound care following vascular operations compared to to a negative pressure wound therapy (vacuum dressing) and the rate of surgical site infections (SSIs) in…
- Trial name
- NCT02084017
- Testing
- Prevena (Negative Pressure Wound Therapy Device), Standard Tegaderm (3M Healthcare, St. Paul, MN) adhesive dressing
- Where
- Canada
- Volunteers
- 80 people
- Sponsor
- Western University, Canada
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
Complication of Surgical Procedure
Incisional Negative Pressure Dressing on Clean Closed Groin Incisions
Wound complications associated with surgical incisions range from minor to life threatening. Surgical site infections occurring usually occur within 30 days and are one of the most common surgical complications.
- Trial name
- NCT02006511
- Testing
- Incisional Neg Pressure Wound Therapy (Prevena™), Standard of Care wound therapy
- Where
- United States
- Sponsor
- University of Maryland, Baltimore
Surgical Wound Infection
Closed Incision Negative Pressure Wound Therapy for the Prevention of Surgical Site Infections in Abdominal Surgery
Surgical site infections (SSI) are a frequent complication in abdominal surgery. SSI lead to worse outcomes for the affected patients and significantly higher healthcare costs.
- Trial name
- CISSI (NCT06068517)
- Testing
- Closed incision negative pressure wound therapy, Standard dressing
- Where
- Switzerland
- Volunteers
- 654 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Surgical Site Infection, Surgical Wound
Optimizing Closed Incision Negative Pressure Wound Therapy in Emergency Laparotomy
The purpose of this study is to find differences in rates of surgical site infections following emergency laparotomy with the use of two different incisional negative pressure wound therapy (iNPWT)devices.
- Conditions
- Surgical Site Infection, Surgical Wound, Surgical Wound Infection, Surgical Complication
- Trial name
- OPTIWOUND (NCT05716490)
- Testing
- Incisional negative pressure wound therapy, Control group - standard wound dressing
- Where
- Portugal
- Volunteers
- 114 people
- Sponsor
- Centro Hospitalar do Tâmega e Sousa
Healthy, Macromastia
NPWT Reduction Mammaplasty
In this prospective, randomized, split-body control trial, we aim to compare complications, patient-reported outcomes, and cost differentials following reduction mammaplasty with prophylactic closed incision negative pressure…
- Conditions
- Healthy, Macromastia, Negative Pressure Therapy, Mammaplasty
- Trial name
- NCT06725459
- Testing
- Prophylactic ciNPWT, Standard Adhesive Dressing
- Where
- United States
- Volunteers
- 92 people
- Sponsor
- Medstar Health Research Institute
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.
Post-operative Complications, Surgical Site Infection
The Use of the Prevena™ Incision Management System on Post-Surgical Cesarean Section Incisions
The purpose of this study is to compare the post-surgical standard-of-care dressing to the Prevena™ Incision Management System in women undergoing Cesarean section surgery.
- Conditions
- Post-operative Complications, Surgical Site Infection, Surgical Wound Infection
- Trial name
- NCT01450631
- Testing
- Prevena™ Incision Management System (PIMS), Standard-of-care Dressing
- Where
- United States
- Volunteers
- 92 people
- Sponsor
- KCI USA, Inc
Surgical Wound
Clinical Evaluation of a Novel Incisional NPWT System
A study of the first clinical use in humans of a novel NPWT system (npSIMS) to assess the suitability, safety and efficacy of the system for the management of closed surgical wounds
- Trial name
- NCT04488666
- Testing
- npSIMS
- Where
- New Zealand
- Volunteers
- 23 people
- Sponsor
- Aatru Medical LLC
ExtraCorporeal Membrane Oxygenation (ECMO), Wound Complications
Closed Incision NPWT to Prevent Wound Complications Post-ECMO
Patients undergoing extracorporeal membrane oxygenation (ECMO) are at increased risk of wound complications at the vascular access site after decannulation. These complications may delay recovery and increase healthcare burden.
- Conditions
- ExtraCorporeal Membrane Oxygenation (ECMO), Wound Complications, Surgical Site Infection (SSI)
- Trial name
- PREVENT-ECMO (NCT07709546)
- Testing
- Prophylactic Closed-Incision Negative Pressure Wound Therapy, Standard Wound Dressing
- Volunteers
- 144 people
- Sponsor
- St. Antonius Hospital
Bilateral Vascular Groin Surgery
Evaluation of the Effectiveness of a Closed-incision Negative-pressure Therapy (Prevena®) on Bilateral Groin Incision
Closed-incision negative-pressure therapy are medical device that are suspected to reduce groin wound complication in vascular surgery.
- Trial name
- PREVISION (NCT04174183)
- Testing
- Closed-incision Negative-pressure Therapy - Dry dressing
- Where
- France
- Volunteers
- 84 people
- Sponsor
- Central Hospital, Nancy, France
Incisional Hernia, Surgical Wound Infection
Prophylactic Negative Pressure Wound Therapy for Patients Undergoing Incisional Hernia Repair
The study will examine the effect of using Negative Pressure Wound Therapy (NPWT) compared with standard wound dressing among patients undergoing elective open surgery for incisional hernia.
- Conditions
- Incisional Hernia, Surgical Wound Infection, Surgical Site Infection, Quality of Life
- Trial name
- PROPRESS (NCT05050786)
- Testing
- Negative Wound Pressure Therapy (Prevena(TM)), Standard Wound Dressing
- Where
- Denmark
- Volunteers
- 110 people
- Sponsor
- Kristian Kiim Jensen