Negative Pressure Wound Therapy in Obese Gynecologic Oncology Patients

NCT02309944 | Completed Results DMC

• 1 other identifier: 2013NTLS073
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Complications; Obesity; Gynecologic Neoplasms

Keywords

Wound Healing; Obesity; Gynecologic Surgery; Gynecologic Neoplasms; Surgical Complications

Outcome Measures

Primary Outcomes (1)

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

  one month after surgery

Secondary Outcomes (1)

• Time From Surgery to Starting Adjuvant Therapy Among Those With Confirmed Malignancies

  up to 20 weeks

Study Arms (2)

Standard Wound Closure

ACTIVE COMPARATOR

Standard surgical closure of the fascia and skin.

Procedure: Standard Wound Closure

Negative Pressure Wound Therapy

EXPERIMENTAL

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

Procedure: Standard Wound Closure; Device: Prevena™ Incision Management System

Interventions

Standard Wound Closure PROCEDURE

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.

Negative Pressure Wound Therapy; Standard Wound Closure

Prevena™ Incision Management System DEVICE

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.

Negative Pressure Wound Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Known or suspected gynecologic or other abdominal malignancy (such as colorectal, liver, pancreatic, kidney and stomach) for which laparotomy is planned
• Obese - defined as a Body Mass Index (BMI) ≥ 35 kg/m2 as calculated in the Epic computer record

You may not qualify if:

• Known true tape allergy
• Sensitivity to silver
• History of intolerance to Negative Pressure Wound Therapy

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Postoperative Complications; Obesity; Genital Neoplasms, Female

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Deanna GK Teoh
• Organization: Masonic Cancer Center, University of Minnesota

dkteoh@umn.edu

612-626-3111

Study Officials

• Deanna G. Teoh, M.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2014
• First Posted: December 5, 2014
• Study Start: May 1, 2015
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: July 27, 2020
• Results First Posted: July 27, 2020

Record last verified: 2020-07

Locations

US (1)