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

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

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.

Study Overview

• Status: Unknown
• Conditions: Perianal Abscess
• Intervention / Treatment: Other: External dressing; Other: Packing of abscess cavity

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non-packing of abscess cavity	Other: External dressing; Application of external dressing whilst abscess cavity heals
Other: Packing of abscess cavity; Current practice	Other: External dressing; Application of external dressing whilst abscess cavity heals; Other: Packing of abscess cavity

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life scores as determined by the Euro QoL EQ-5D-3L	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	10 to 14 days

Other Outcome Measures

Outcome Measure	Time Frame
Abscess recurrence rate	0 days to 12 months
Fistula-in-ano formation rate	0 days to 18 months
Cost	0 days to 18 months

Collaborators and Investigators

• Sponsor: North Western Research Collaborative

Study record dates

Study Major Dates

• Primary Completion (Anticipated): January 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: November 29, 2012
• First Submitted That Met QC Criteria: November 30, 2012
• First Posted (Estimate): December 3, 2012

Study Record Updates

• Last Update Posted (Estimate): December 4, 2012
• Last Update Submitted That Met QC Criteria: December 2, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Suppuration; Abscess
• Other Study ID Numbers: NWRC-PPAC