Infections

All Conditions

Symptoms and General Pathology

Wounds and Injuries

Nervous System Diseases

Neoplasms

Diseases and Abnormalities at or Before Birth

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Communicable Diseases

Surgical Wound Infection

Spinal Cord Injuries

Neoplasm Metastasis

Congenital Abnormalities

Infertility

Spinal Cord Diseases

Central Nervous System Diseases

Trauma, Nervous System

Neoplastic Processes

Standard of care treatment - Standard wound care involves the application of an occlusive dressing in the operating room, a dressing change on Post-operative Day 3 and then dressing changes as needed until suture/staple removal on Post-operative Day 14.

The Prevena™ System, a type of vacuum assisted closure, is indicated for use over clean, closed incisions that continue to drain following sutured or stapled closure. It acts by removing exudate, helping hold the edges of the incision together, protecting the surgical site from external contamination in a clean, protected postoperative wound environment.

Patients will be randomized to receive either standard dressing changes or the Prevena™ System on the day of their operation.

Vacuum Assisted Closure

Standard wound care involves the application of an occlusive dressing in the operating room, a dressing change on Post-operative Day 3 and then dressing changes as needed until suture/staple removal on Post-operative Day 14.

Sterile dressing

Allan Aludino

Leilani Reichl

John Street, MD, PhD

John Street, MD,PhD,FRCSI

The purpose of this study is to determine if the use of the Prevena™ System decreases the rate of subcutaneous seroma, superficial wound dehiscence and infection.

Certain risk factors have been identified in patients that may lead to poor wound healing or infection. Many things have been tried to decrease this risk (more antibiotics, different types of stitches, etc) but very few have been shown to be of any significant benefit.

The use of a special vacuum dressing called the Prevena™ System, which has received approval from Health Canada for the management of closed surgical incisions, has been shown to be of some benefit in hip surgery where wounds are identified as being "at risk." Vacuum dressings have been used with great success in patients with open wounds and have resulted in fewer infections and wound related complications. It is thought that if vacuum dressings can be used in the treatment of existing wounds, then maybe they can be used preventatively before there is a problem with the wound.

Standard wound care after spine surgery involves a dressing that seals the wound for 72 hours after surgery and is then changed on a daily basis until the surgical sutures or staples are ready to be removed. This has been routine for many years.

The purpose of this study is to see if using a vacuum dressing (Prevena™ System) will decrease the number of infections and/or clinic and hospital visits for wound related issues compared to using a standard dressing on wounds in patients with risk factors for early wound infection.

Negative Pressure Wound Therapy vs. Sterile Dressing for Patients Undergoing Thoracolumbar Spine Surgery

A Prospective Randomized Clinical Trial Comparing Incisional Negative Pressure Wound Therapy to Conventional Sterile Dressing in Patients Undergoing Thoracolumbar Posterior Spine Surgery

Based on visual inspection of the surgical site, a 'Wound Inspection \& Dressing Utilization' case report form will be completed by a clinician, concluding at Week 6 post-op, to assess for the presence of SSI.

University of British Columbia Orthopaedics Research Excellence Fund

John Street

Assistant Professor

Skin and Connective Tissue Diseases

Rare Diseases

Carcinoma

Carcinoma, Neuroendocrine

Melanoma

Skin Neoplasms

Carcinoma, Squamous Cell

Lymphatic Metastasis

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Adenocarcinoma

Neoplasms, Squamous Cell

Neuroendocrine Tumor

Neuroepithelioma

A vacuum wound closure therapy like PREVENA is applied after axillary or inguinal lymph node dissection in the management of metastatic skin tumors

A conventional wound closure is applied after axillary or inguinal lymph node dissection in the management of metastatic skin tumors

A negative pressure wound closure therapy is used after lymph node dissection

PREVENA

Manuela PEREZ

In this study, we compared a negative pressure wound therapy, versus a conventional dressing in order to evaluate the most efficient wound therapy closure after axillary and inguinal lymph nodes dissections in the management of metastatic skin tumors. A vacuum assisted closure therapy should prevent these comorbidities.

Lymphorrhoea, lymphedema and lymphocyte are significant and common complications after axillary and inguinal lymph nodes dissections. A vacuum assisted closure therapy should prevent these comorbidities. In this study, we compared PREVENA, a negative pressure wound therapy, versus conventional dressings. We evaluated the wound complications at the seventh day, the thirtieth day and at this end of the first year after surgery. It is a retrospective study of about ninety lymph nodes dissections among with there were seventy times the use of a negative pressure wound therapy, PREVENA.

The Aim of This Study is to Demonstrat That Vacuum-assisted Closure Versus Conventional Wound Closure Enables to Diminish Local Complications After Lymph Node Dissection in Patients With Metastatic Skin Tumors

Does PREVENA Vacuum-assisted Closure Reduce Lymphorrhoea Compared to Conventional Wound Closure After Axillary and Inguinal Lymph Node Dissection in the Management of Metastatic Cutaneous Skin Tumors ?

Yes if there is a scar opening, no if there isn't

Yes if there is lymph coming from the the scar, no if there isn't.

Yes if there is any lymphocele puncture, no if there isn't

Yes if there is arm or leg lymphoedema, no if there isn't

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Negative Pressure Wound Therapy vs. Sterile Dressing for Patients Undergoing Thoracolumbar Spine Surgery	NCT03632005	Metastatic Dise... Spinal Cord Inj... Spinal Degenera... Spinal Deformit...	Vacuum Assisted... Sterile dressin...	17 Years -	University of British Columbia
Negative Pressure Wound Therapy vs. Sterile Dressing for Patients Undergoing Thoracolumbar Spine Surgery	NCT03632005	Metastatic Dise... Spinal Cord Inj... Spinal Degenera... Spinal Deformit...	Vacuum Assisted... Sterile dressin...	17 Years -	University of British Columbia
The Aim of This Study is to Demonstrat That Vacuum-assisted Closure Versus Conventional Wound Closure Enables to Diminish Local Complications After Lymph Node Dissection in Patients With Metastatic Skin Tumors	NCT04583605	Melanoma Skin Cancer Epidermoid Carc... Neuroendocrine ... Lymph Node Meta...	PREVENA	18 Years -	Central Hospital, Nancy, France

Spots Global Cancer Trial Database for vacuum assisted closure