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

Not Applicable

• Conditions: Perianal Abscess

• Registration Number: NCT01739478
• Lead Sponsor: North Western Research Collaborative

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-29
• Study First Submitted QC: 2012-11-30
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-02
• Study First Posted: 2012-12-03
• Last Update Posted: 2012-12-04
• Primary Completion: 2015-01
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Quality of life scores as determined by the Euro QoL EQ-5D-3L	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