CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 290 enrolled / 290 target
Drug / intervention
Negative Pressure Wound Therapydevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04955730
NCT04955730Phase 2CompletedHigh Momentum (4.9/mo)Completion was 14mo ago
CompareCT.gov

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

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Jul 9, 2021·Updated Jun 9, 2026

In Brief

A Phase 2 clinical trial evaluating Negative Pressure Wound Therapy for Surgical Wound Infection. Completed, enrolled 290 participants across 1 site.

Signals

Enrolling ahead of pace

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSurgical Wound Infection
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedJul 9, 2021
Enrollment StartAug 5, 2021
Primary CompletionApr 30, 2025
Study CompletionSep 23, 2025
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 5.0 years ago

Arms & Interventions

NPWT - Negative Pressure Wound Therapyexperimental

Participants will receive Negative Pressure Wound Therapy (NPWT) after surgery and wear the NPWT until postop day 3. NPWT dressing will be removed and a new NPWT will be replaced until Postop day 7, where NPWT dressing will be removed.

Device: Negative Pressure Wound Therapy
Standard of Care Wound Therapyno_intervention

Participants will receive standard of care wound therapy after surgery. Postop day 3, dressings will be removed and new sterile dressings will be applied if needed.

Interventions

Negative Pressure Wound Therapydevice

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.