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ENVELOP: Wound Care Following Pilonidal Sinus Surgery

Study acronym: ENVELOP
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Oct 1, 2026 → Dec 2026
See other at-risk trials from Royal College of Surgeons, Ireland

Record History

  1. Interventions modified Secondary endpoints: 18 to 7 · Study sites revised (10) · Eligibility criteria shortened, about 1 word Show 3 more changesShow less
    • Secondary endpoints: 18 to 7
    • Study sites revised (10)
    • Eligibility criteria shortened, about 1 word
  2. Primary completion pushed from Oct 1, 2026 to Dec 2026 Completion pushed from Apr 27, 2027 to Jun 2027 · Study sites revised (10)v3 Show 2 more changesShow less
    • Completion pushed from Apr 27, 2027 to Jun 2027
    • Study sites revised (10)

    See this version in full on ClinicalTrials.gov ↗

  3. Site details revised at 1 of 10 sitesv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a single-blinded, multicentre, prospective randomised controlled trial (RCT) comparing post-operative and patient-reported outcomes for patients undergoing application of negative-pressure wound therapy (NPWT) after sinus tract excision as compared to excision and standard open wound care in chronic pilonidal sinus disease (PSD).
Trial Details
NCT Number NCT06647290
Lead Sponsor Royal College of Surgeons, Ireland
Conditions Pilonidal Sinus, Wound Healing
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov