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Clinical Trial Summary

Stoma reversal is associated with high incidence of post-surgical complications, including Surgical Site Infections (SSI). Negative Pressure Wound Therapy (NPWT) has been successfully applied to surgical wound management, reducing the SSIs incidence. This is a randomized open-label trial to assess the efficacy of NPWT in decreasing the rate of SSI after stoma reversal.


Clinical Trial Description

Stoma reversal after abdominal resection is associated with several complications, of which the most common is wound infection. Surgical Site Infections (SSI) usually result in increased long-term complications, such as incisional hernia, prolonged hospital stay, increased outpatients visits and medical costs. Negative-Pressure-Wound-Therapy (NPWT) is a technique using vacuum dressing, commonly used to promote surgical wound healing, but there is a significant lack of knowledge about its safety and efficacy in promoting wound healing after stoma closure. This is an interventional, randomized, open label trial to evaluate the safety and efficacy of the NPWT (PICO™ system, Smith&Nephew Healthcare, Hull, UK) on stoma wound compared to Standard of Care (SOC). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03781206
Study type Interventional
Source Istituto Clinico Humanitas
Contact Annalisa Maroli, PhD
Phone +39 02 8224 7776
Email annalisa.maroli@humanitas.it
Status Recruiting
Phase N/A
Start date July 18, 2019
Completion date June 1, 2021

See also
  Status Clinical Trial Phase
Not yet recruiting NCT04974931 - Application of PREVENA in Reducing Surgical Site Complications Following Reversal of Ileostomy or Colostomy N/A