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NCT03781206: NESTOR

Negative Pressure Wound Therapy for Wound Healing After Stoma Reversal

Status unknown NA Last updated 5 February 2021
What this trial tests

NA trial testing PICO™ 7 in Stoma Site Infection in 100 participants. Status unknown.

Timeline
18 July 2019
Primary endpoint
1 March 2021
1 June 2021

Quick facts

Lead sponsorIstituto Clinico Humanitas
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment100
Start date18 July 2019
Primary completion1 March 2021
Estimated completion1 June 2021
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Istituto Clinico Humanitas

Who can join

18 and older, any sex, with Stoma Site Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Negative pressure wound therapy for surgical wounds healing by primary closure.
    Norman G, Shi C, Goh EL, Murphy EM, et al · · 2022 · cited 71× · PMID 35471497 · DOI 10.1002/14651858.cd009261.pub7
  2. Negative pressure wound therapy for surgical wounds healing by primary closure.
    Norman G, Goh EL, Dumville JC, Shi C, et al · · 2020 · cited 48× · PMID 32542647 · DOI 10.1002/14651858.cd009261.pub6
  3. Negative pressure wound therapy for surgical wounds healing by primary closure.
    Norman G, Goh EL, Dumville JC, Shi C, et al · · 2020 · cited 38× · PMID 32356396 · DOI 10.1002/14651858.cd009261.pub5
  4. Characteristics of Interventional Trials for Patients Living With Intestinal Stoma Registered in ClinicalTrials.gov With a Focus on Inflammatory Bowel Disease.
    Vuyyuru SK, Ma C, Sharma T, Nguyen TM, et al · · 2024 · cited 3× · PMID 38135729 · DOI 10.1093/ibd/izad293

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Other Istituto Clinico Humanitas trials

Trials by the same sponsor.

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