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PINTA - Prophylactic Incisional Negative Pressure Therapy for Major Amputations

Study acronym: PINTA
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Mar 1, 2026 to Jul 2028 Completion date: Dec 20, 2026 to Dec 2028 · Study sites revised (7)v4 Show 2 more changesShow less
    • Completion date: Dec 20, 2026 to Dec 2028
    • Study sites revised (7)

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Dec 1, 2023 to Mar 1, 2024 · Primary endpoint revised · Primary completion date: Dec 1, 2026 to Mar 1, 2026 · 3 morev3 Show 6 more changesShow less
    • Start date changed from estimate of Dec 1, 2023 to Mar 1, 2024
    • Primary endpoint revised
    • Primary completion date: Dec 1, 2026 to Mar 1, 2026
    • Completion date: Dec 1, 2026 to Dec 20, 2026
    • Secondary endpoints: 2 to 13
    • Study description shortened, about 458 words

    See this version in full on ClinicalTrials.gov ↗

  3. Primary and study completion dates: Mar 1, 2026 to Dec 1, 2026 Start date: Sep 1, 2023 to Dec 1, 2023 · Primary endpoint revised · Eligibility criteria revised · 2 morev2 Show 5 more changesShow less
    • Start date: Sep 1, 2023 to Dec 1, 2023
    • Primary endpoint revised
    • Eligibility criteria revised
    • Secondary endpoints revised (2)
    • Study description shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Post-operative wound issues in abdominal surgery have a significant impact on patient outcomes. This study is taking place to investigate if Negative Pressure Wound Therapy (NPWT) dressings reduces Surgical Site Infections, post surgical complications and improves scar appearance compared to standard dressings.
Trial Details
NCT Number NCT06025253
Lead Sponsor Royal College of Surgeons, Ireland
Conditions Wound Surgical, Wound Infection, Cosmesis
Enrollment 728 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov