Negative-Pressure Wound Therapy Clinical Trial
Official title:
A Phase III Randomized Controlled Trial of Negative Pressure Wound Therapy in Post-Operative Incision Management
Verified date | January 2024 |
Source | Memorial Sloan Kettering Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare any good and bad effects of using the Prevena Incision Management System to using the usual standard dry gauze approach. The Prevena Incision Management System is a type of Negative Pressure Wound Therapy (NPWT). NPWT is a portable vacuum device made of a sponge-like foam that is applied over your incision to help draw fluid and debris out after surgery.
Status | Completed |
Enrollment | 577 |
Est. completion date | January 25, 2024 |
Est. primary completion date | January 25, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Criteria for Eligibility Prior to Surgery: - Women of any BMI undergoing a laparotomy procedure for a presumed gynecologic malignancy, or morbidly obese (BMI = 40) women undergoing a laparotomy for any indication - or women who are morbidly obese (BMI>40) undergoing laparotomy for any indication - Age = 18 Criteria for Eligibility During Surgery: - Women of any BMI undergoing a laparotomy procedure for a presumed gynecologic malignancy, or morbidly obese (BMI = 40) women undergoing a laparotomy for any indication - or women who are morbidly obese (BMI>40) undergoing laparotomy for any indication - Age = 18 Exclusion Criteria: Exclusion prior to Surgery: - Women undergoing panniculectomy at the time of laparotomy - Women with sensitivity to silver Exclusion during Surgery: - Women with laparotomy incisions left open due to case classification as "contaminated" or "dirty" - Women with laparotomy incisions unable to be closed primarily due to tissue or fascial damage |
Country | Name | City | State |
---|---|---|---|
United States | Lehigh Valley Health Network | Allentown | Pennsylvania |
United States | Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up only) | Basking Ridge | New Jersey |
United States | Memorial Sloan Kettering Commack (Consent and Follow-Up only) | Commack | New York |
United States | Memorial Sloan Kettering Westchester (Consent and Follow-Up only) | Harrison | New York |
United States | Hartford Healthcare Cancer Institute @ Hartford Hospital | Hartford | Connecticut |
United States | Memorial Sloan Kettering Monmouth (Consent and Follow-Up only) | Middletown | New Jersey |
United States | Memorial Sloan Kettering Bergen (Consent and Follow-Up only) | Montvale | New Jersey |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | Memorial Sloan Kettering Rockville (Consent and Follow-Up only) | Rockville Centre | New York |
United States | Memorial Sloan Kettering Nassau (Consent and Follow-Up only) | Uniondale | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center | 3M, Miami Cancer Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | number of post-op wound complications | Incidence of inpatient post-operative wound complications will be documented through the use of an inpatient data collection sheet. Incidence of outpatient post-operative wound complication will be documented through the use of an outpatient data collection sheet that will be completed by a provider at the time of the routine post-operative follow-up visit, which will occur at 30 days +/- 5 days after the day of surgery as well as through ongoing documentation of events as elicited through the institution's standard reporting system to collect information on enrolled patients. | 30 days +/- 5 days after surgery |
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