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

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ClinicalTrials.gov Identifier: NCT01739478
Recruitment Status : Unknown
Verified December 2012 by North Western Research Collaborative.
Recruitment status was:  Not yet recruiting
First Posted : December 3, 2012
Last Update Posted : December 4, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Perianal Abscess Other: Packing of abscess cavity Other: External dressing

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Packing of Perianal Abscess Cavities (PPAC) Trial: A Randomised Multicentre Trial Comparing Packing With Non-packing of the Abscess Cavity
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Abscess recurrence rate [ Time Frame: 0 days to 12 months ]
  2. Fistula-in-ano formation rate [ Time Frame: 0 days to 18 months ]
  3. Cost [ Time Frame: 0 days to 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Responsible Party: North Western Research Collaborative
ClinicalTrials.gov Identifier: NCT01739478     History of Changes
Other Study ID Numbers: NWRC-PPAC
First Posted: December 3, 2012    Key Record Dates
Last Update Posted: December 4, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Abscess
Suppuration
Infection
Inflammation
Pathologic Processes