A Phase 3 interventional study of dry gauze and The Prevena Incision Management System in Negative-Pressure Wound Therapy, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 10 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-18.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 3, Interventional, and Treatment
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.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's enrollment of 583 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
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Inclusion Criteria:
Criteria for Eligibility Prior to Surgery:
Criteria for Eligibility During Surgery:
Exclusion Criteria:
Exclusion prior to Surgery:
Exclusion during Surgery:
Patients who are randomized to the standard dry gauze arm will have the standard dry gauze placed at time of wound closure. Their dressing will be removed on post-operative day 2 as per routine departmental practice.
Other: dry gauze
Patients who are randomized to the Prevena Therapy System arm will have the Prevena Incision Management System device placed at time of wound closure. The device will be removed on day of discharge from the hospital or post-operative day 7, whichever comes first.
Device: The Prevena Incision Management System
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.
Time frame: 30 days +/- 5 days after surgery
| Milestone | Usual Standard Dry Gauze Used for Wound Management | Prevena Negative Pressure Wound Therapy System (NPWT) |
|---|---|---|
| Started | 294 | 289 |
| Completed | 251 | 254 |
| Not completed | 43 | 35 |
| Withdrew: Benign final pathology | 27 | 26 |
| Withdrew: Reoperation before 30 days | 7 | 6 |
| Withdrew: Ineligible | 1 | 0 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Lost to follow-up | 7 | 3 |
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.
| Wound Complications | Usual Standard Dry Gauze Used for Wound Management | Prevena Negative Pressure Wound Therapy System (NPWT) |
|---|---|---|
| Inpatient wound complication | 2 | 5 |
| Outpatient wound complication | 42 | 36 |
Collected over 30 days +/- 5 days after surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Usual Standard Dry Gauze Used for Wound Management | 1/251 (0.4%) | 51/251 (20.3%) | 11/251 (4.4%) |
| Prevena Negative Pressure Wound Therapy System (NPWT) | 0/254 (0%) | 69/254 (27.2%) | 44/254 (17.3%) |
| Event | Usual Standard Dry Gauze Used for Wound Management | Prevena Negative Pressure Wound Therapy System (NPWT) |
|---|---|---|
| IleusGastrointestinal disorders | 10/251 | 13/254 |
| AnemiaBlood and lymphatic system disorders | 5/251 | 4/254 |
| Small intestinal obstructionGastrointestinal disorders | 2/251 | 4/254 |
| Abdominal infectionInfections and infestations | 3/251 | 2/254 |
| Acute kidney injuryRenal and urinary disorders | 3/251 | 1/254 |
| AscitesGastrointestinal disorders | 3/251 | 3/254 |
| Thromboembolic eventVascular disorders | 2/251 | 3/254 |
| Atrial fibrillationCardiac disorders | 2/251 | 1/254 |
| Colonic perforationGastrointestinal disorders | 2/251 | 0/254 |
| Gastrointestinal anastomotic leakInjury, poisoning and procedural complications | 2/251 | 0/254 |
| Event | Usual Standard Dry Gauze Used for Wound Management | Prevena Negative Pressure Wound Therapy System (NPWT) |
|---|---|---|
| Skin blisteringSkin and subcutaneous tissue disorders | 3/251 | 33/254 |
| Contact dermatitisSkin and subcutaneous tissue disorders | 4/251 | 6/254 |
| Wound painInjury, poisoning and procedural complications | 2/251 | 6/254 |
| VAS pain levelInjury, poisoning and procedural complications | 2/251 | 6/254 |
| Age, Continuous(years) | Usual Standard Dry Gauze Used for Wound Management | Prevena Negative Pressure Wound Therapy System (NPWT) | Total |
|---|---|---|---|
| Mean | 60 (20 to 85) | 61 (18 to 66) | 60 (18 to 85) |
| Sex: Female, Male(Participants) | Usual Standard Dry Gauze Used for Wound Management | Prevena Negative Pressure Wound Therapy System (NPWT) | Total |
|---|---|---|---|
| Female | 294 | 289 | 583 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Usual Standard Dry Gauze Used for Wound Management | Prevena Negative Pressure Wound Therapy System (NPWT) | Total |
|---|---|---|---|
| Hispanic or Latino | 16 | 22 | 38 |
| Not Hispanic or Latino | 278 | 267 | 545 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Usual Standard Dry Gauze Used for Wound Management | Prevena Negative Pressure Wound Therapy System (NPWT) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 16 | 23 | 39 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 14 | 23 | 37 |
| White | 245 | 233 | 478 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 19 | 10 | 29 |
| Region of Enrollment(Participants) | Usual Standard Dry Gauze Used for Wound Management | Prevena Negative Pressure Wound Therapy System (NPWT) | Total |
|---|---|---|---|
| United States | 294 | 289 | 583 |
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Memorial Sloan Kettering Cancer Center