Efficacy of Prophylactic Negative Pressure Wound Therapy (NPWT)

NCT05727995 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-02-14

No results posted yet for this study

Summary

The role of prophylactic negative pressure wound therapy (NPWT) is promising in reducing wound-related complications. However, the prophylactic use of NPWT in reducing wound complications in patients who underwent conventional open harvesting of the great saphenous vein has been under-investigated compering with other surgical approaches.

Therefore, this study aims to assess the effect size of the prophylactic NPWT in preventing wound dehiscence in high-risk patients who underwent conventional open harvesting of the great saphenous vein as a conduit for coronary artery bypass.

Conditions

  • Wound of Skin

Interventions

DEVICE

PICO7

The use of PICO is contraindicated in the presence of: * Patients with malignancy in the wound bed or margins of the wound * Previously confirmed and untreated osteomyelitis * Nonenteric and unexplored fistulas * Necrotic tissue with eschar present * Exposed arteries, veins, nerves or organs * Exposed anastomotic sites * Emergency airway aspiration * Pleural, mediastinal or chest tube drainage * Surgical suction.

OTHER

usual care dressing

usual care dressing

Sponsors & Collaborators

  • IRCCS Policlinico S. Donato

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-25
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05727995 on ClinicalTrials.gov