NCT03315169

Packing of Perianal Abscess Cavities

The Impact of Postoperative Packing of Perianal Abscess Cavities: a Multicentre Randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 433 (actual)
• Sponsor: Manchester University NHS Foundation Trust · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this trial is to compare internal wound packing to no packing in postoperative management following incision and drainage of perianal abscess. Participants will be randomised 1:1 to either the packing or non-packing arm.

Detailed description

Perianal abscess is common, affecting 18,000 patients annually in England. Management has remained largely unchanged for over 50 years, and comprises surgical incision and drainage followed by continued internal wound dressing (packing) until healed. Packing is thought to reduce the rate of recurrent abscess and perianal fistula; a known complication of perianal abscess. Perianal fistula frequently requires multiple operations to resolve. The evidence for postoperative packing is limited¹ and may expose patients to painful procedures with no clinical benefit, and at considerable increased cost². A multi-centre observational study of outcomes after drainage of perianal abscess (PPAC²) (n=141) found packing to be painful (2-3 fold increase in Visual Analogue Score pain scores during packing) and costly (estimated cost of £280 per patient; overall cost in the United Kingdom of £5 million annually). Fistula rate was 27%. This study is a randomised controlled trial designed to assess whether there are differences between non-packing and packing of the perianal abscess cavity in terms of the short term negative effects of packing (pain, quality of life, return to work) whilst assessing the impact on key clinical outcomes (wound healing, fistulae formation) and resource use/cost. All participants will be required to complete pain diaries following discharge from hospital. Clinical follow up to assess healing and other key clinical outcomes will take place at 4, 8 (if not healed at 4 weeks) and 26 weeks. Further data will be collected from National Health Service Registries at 52 weeks in order to assess abscess recurrences and fistulae formation.

Conditions

• Perianal Abscess
• Perianal Infections
• Peri Rectal Abscess
• Abscess; Anus
• Abscess Anorectal

Interventions

Type	Name	Description
OTHER	External dressing	Application of external dressing whilst perianal abscess cavity heals.
OTHER	Packing of perianal abscess cavity	Internal packing of perianal abscess cavity - standard treatment.

Timeline

• Start date: 2018-02-14
• Primary completion: 2020-06-12
• Completion: 2020-06-12
• First posted: 2017-10-20
• Last updated: 2020-09-09

Locations

50 sites across 1 country: United Kingdom