Trials / Completed
CompletedNCT01656044
Negative Pressure Therapy in Preventing Infection After Surgery in Patients With Colon, Rectal, Pancreatic, or Peritoneal Surface Cancer
The Effect of Negative Pressure Therapy on Incisional Surgical Site Infections
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 375 (actual)
- Sponsor
- Wake Forest University Health Sciences · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this research study is to evaluate if a negative-pressure dressing placed over a surgical incision can reduce the risk of developing a surgical site infection compared to a commonly-used sterile gauze incision dressing. In this study, the negative-pressure dressing will be compared to a standard post-surgical sterile gauze dressing. In this study patients will either receive a negative-pressure dressing or a standard sterile gauze dressing
Detailed description
PRIMARY OBJECTIVES: I. To determine whether negative pressure therapy applied to closed laparotomy incisions can decrease the incidence of incisional surgical site infections in patients undergoing clean-contaminated resections for colorectal, pancreatic, and peritoneal surface malignancies compared to standard post-operative sterile gauze dressings. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive standard sterile dressing (SSD) over their closed laparotomy incision at the conclusion of their surgery. ARM II: Patients receive negative pressure therapy (NPT) dressing over their closed laparotomy incision at the conclusion of their surgery. After completion of study treatment, patients are followed up at 30 days.
Conditions
- Colon Cancer
- Pancreatic Cancer
- Perioperative/Postoperative Complications
- Primary Peritoneal Cavity Cancer
- Rectal Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | wound care management | Receive SSD |
| PROCEDURE | wound care management | Receive NPT |
Timeline
- Start date
- 2012-06-01
- Primary completion
- 2016-10-01
- Completion
- 2016-10-01
- First posted
- 2012-08-02
- Last updated
- 2018-07-03
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01656044. Inclusion in this directory is not an endorsement.