NCT04955730

NPWT in Patients Undergoing Surgical Procedures for Management of GI Malignancies

Randomized Trial of Prolonged Use of Negative Pressure Wound Therapy in Patients Undergoing Surgical Procedures for the Management of Gastrointestinal Malignancies

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 290 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized trial will use a Negative Pressure Wound Therapy device or standard wound closure, in participants with gastrointestinal neoplasms, to measure the rate of surgical site infections

Conditions

• Surgical Wound Infection

Interventions

Type	Name	Description
DEVICE	Negative Pressure Wound Therapy	Negative Pressure Wound Therapy is a single use NPWT that produces a negative pressure at -80 mmHg. Participants will have their fascia and skin closed in the same manner as the control arm participants, and will wear the NPWT dressing for 7 days after surgery.

Timeline

• Start date: 2021-08-05
• Primary completion: 2025-04-30
• Completion: 2026-03-01
• First posted: 2021-07-09
• Last updated: 2026-03-02
• Results posted: 2026-03-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study