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

Perianal Abscess Clinical Trial

— PPAC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01739478
• Other study ID #: NWRC-PPAC
• Status: Not yet recruiting
• Phase: N/A
• First received: November 29, 2012
• Last updated: December 2, 2012
• Est. completion date: December 2015

Study information

• Verified date: December 2012
• Source: North Western Research Collaborative
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Institute for Health Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Abscess
• Perianal Abscess

Intervention

Other:
• Packing of abscess cavity

• External dressing
Application of external dressing whilst abscess cavity heals

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
North Western Research Collaborative

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Abscess recurrence rate		0 days to 12 months	Yes
Other	Fistula-in-ano formation rate		0 days to 18 months	Yes
Other	Cost		0 days to 18 months	No
Primary	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	No
Secondary	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	No