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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2012 by North Western Research Collaborative
Sponsor:
Information provided by (Responsible Party):
North Western Research Collaborative
ClinicalTrials.gov Identifier:
NCT01739478
First received: November 29, 2012
Last updated: December 2, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Perianal Abscess
Other: Packing of abscess cavity
Other: External dressing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Packing of Perianal Abscess Cavities (PPAC) Trial: A Randomised Multicentre Trial Comparing Packing With Non-packing of the Abscess Cavity

Further study details as provided by North Western Research Collaborative:

Primary Outcome Measures:
  • Time to wound healing in days, defined as complete epithelialisation of the abscess cavity. [ Time Frame: 1 day to 6 weeks ] [ Designated as safety issue: No ]
    time to healing will be assessed in days


Secondary Outcome Measures:
  • Quality of life scores as determined by the Euro QoL EQ-5D-3L [ Time Frame: 10 to 14 days ] [ Designated as safety issue: No ]
    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


Other Outcome Measures:
  • Abscess recurrence rate [ Time Frame: 0 days to 12 months ] [ Designated as safety issue: Yes ]
  • Fistula-in-ano formation rate [ Time Frame: 0 days to 18 months ] [ Designated as safety issue: Yes ]
  • Cost [ Time Frame: 0 days to 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Non-packing of abscess cavity Other: External dressing
Application of external dressing whilst abscess cavity heals
Packing of abscess cavity
Current practice
Other: Packing of abscess cavity Other: External dressing
Application of external dressing whilst abscess cavity heals

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: North Western Research Collaborative
ClinicalTrials.gov Identifier: NCT01739478     History of Changes
Other Study ID Numbers: NWRC-PPAC
Study First Received: November 29, 2012
Last Updated: December 2, 2012
Health Authority: United Kingdom: National Institute for Health Research

Additional relevant MeSH terms:
Abscess
Infection
Inflammation
Pathologic Processes
Suppuration

ClinicalTrials.gov processed this record on October 23, 2014