Packing of Perianal Abscess Cavities Trial: A Randomised Multicentre Trial Comparing Packing With Non-packing of the Abscess Cavity

Overview

The aim of this study is to compare the effect of packing and non-packing on the healing rate of perianal abscess cavities. Secondary objectives are to assess quality of life, cost effectiveness and rate of abscess recurrence and fistula-in-ano formation. If there is no difference in time to healing and non-packing is shown to be safe, acceptable to the patient and cost effective, this approach may become more widely accepted.

Full Title of Study: “Packing of Perianal Abscess Cavities (PPAC) Trial: A Randomised Multicentre Trial Comparing Packing With Non-packing of the Abscess Cavity”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2015

Interventions

  • Other: Packing of abscess cavity
  • Other: External dressing
    • Application of external dressing whilst abscess cavity heals

Arms, Groups and Cohorts

  • Experimental: Non-packing of abscess cavity
  • Other: Packing of abscess cavity
    • Current practice

Clinical Trial Outcome Measures

Primary Measures

  • Time to wound healing in days, defined as complete epithelialisation of the abscess cavity.
    • Time Frame: 1 day to 6 weeks
    • time to healing will be assessed in days

Secondary Measures

  • Quality of life scores as determined by the Euro QoL EQ-5D-3L
    • Time Frame: 10 to 14 days
    • Quality of life scores as determined by the Euro QoL EQ-5D-3L will be measured at 10-14 days following incision and drainage of abscess

Participating in This Clinical Trial

Inclusion Criteria

  • Clinical diagnosis of acute primary perianal abscess – Have undergone surgical incision and drainage as an emergency Exclusion Criteria:

  • The abscess is the sequelae of concurrent disease or trauma – Fourniers gangrene is suspected – Unable to give informed consent

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • North Western Research Collaborative
  • Provider of Information About this Clinical Study
    • Sponsor

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