Wounds and Injuries

All Conditions

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Obesity

Postoperative Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Standard surgical closure of the fascia and skin.

Standard surgical closure as used by the standard of care group plus placement of the Prevena™ Incision Management System over the closed incision.

The standard surgical closure consists of closure of the fascia with a looped polydioxanone (PDS) suture in a running fashion either in with the use of a mass closure technique or a Smead Jones closure at the discretion of the operating surgeon, closure of the subcutaneous space if \>2 cm deep, followed by staple or suture closure of the skin.

Standard Wound Closure

At the close of surgery, the Prevena™ Incision Management System will be placed over the closed incision. It will be removed on post-operative day 2 or 3 as clinically indicated and prior to the patient's discharge from the hospital.

Prevena™ Incision Management System

Deanna G. Teoh, M.D.

The purpose of the study is to test whether the use of a new wound closure technique can decrease the rates of wound complications in obese cancer patients.

Most gynecologic and many intra-abdominal malignancies are treated with an initial surgical procedure. There has been a dramatic increase in obesity rates in the US with more than one third of US adults being obese (Body Mass Index (BMI) of \> 30kg/m2). There is a direct link between obesity and wound complications following surgery with an increasing BMI leading to increasing rates of complications. Negative pressure wound therapy (NPWT) is a system that utilizes sub-atmospheric pressure to improve wound healing by increasing the formation of granulation tissue. NPWT has been shown to improve outcomes in both the orthopedic and cardiothoracic surgery populations. To date, there is no prospective study evaluating the application of prophylactic NPWT in laparotomy patients.

This study will be a randomized clinical trial. Patients will be enrolled at the time of consent for laparotomy for suspected gynecologic malignancy. Participants will be randomized to one of two groups: 1) Standard closure group (control arm): closure of the fascia, subcutaneous tissue and skin per the surgeon's standard method; or 2) NPWT group (study arm): closure of the fascia, subcutaneous tissue and skin per the surgeon's standard method + placement of a negative pressure wound therapy device over the closed incision for 2-3 days, with removal of the device prior to hospital discharge. The rate of wound complications for two groups will be compared.

Negative Pressure Wound Therapy in Obese Gynecologic Oncology Patients

Negative Pressure Wound Therapy in Obese Gynecologic Oncology Patients: A Randomized Controlled Trial

Masonic Cancer Center, University of Minnesota

Negative Pressure Wound Therapy

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Deanna GK Teoh

Negative Pressure Wound Therapy vs. Standard Wound Closure

Follow up data is not available for 2 participants

Number of Participants Who Experience Wound Complications (Wound Dehiscence or Infection)

Only those participants who received adjuvant therapies were analyzed in both arms. Rest of the patients didn't have cancer that required subsequent therapies.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Negative Pressure Wound Therapy in Obese Gynecologic Oncology Patients	NCT02309944	Postoperative C... Obesity Gynecologic Neo...	Standard Wound ... Prevena™ Incisi...	18 Years -	Masonic Cancer Center, University of Minnesota
Negative Pressure Wound Therapy in Obese Gynecologic Oncology Patients	NCT02309944	Postoperative C... Obesity Gynecologic Neo...	Standard Wound ... Prevena™ Incisi...	18 Years -	Masonic Cancer Center, University of Minnesota

Spots Global Cancer Trial Database for prevena™ incision management system