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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