Packing of Perianal Abscess Cavities (PPAC2)

NHS Foundation Trust

Status: Completed

Conditions: Peri Rectal Abscess; Perianal Infections; Abscess; Anus; Abscess Anorectal; Perianal Abscess

Treatments: Other: External dressing; Other: Packing of perianal abscess cavity

Study type: Interventional

Funder types: Other

Identifiers

NCT03315169

PB-PG-0815-20037 (Other Grant/Funding Number)

R04689

Details and patient eligibility

About

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.

Full 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.

Enrollment: 433 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 18 or over
2. Undergoing surgical incision and drainage of a primary perianal abscess

Exclusion criteria

1. Suspected inflammatory bowel disease
2. Fournier's Gangrene
3. Horseshoe (bilateral) abscess
4. Fistula-in-ano
5. Multiple abscess

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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433 participants in 2 patient groups

Packing of perianal abscess cavity

Active Comparator group

Description:

Internal packing of perianal abscess cavity as per normal practice.

Treatment:

Other: Packing of perianal abscess cavity

External dressing

Experimental group

Description:

External application of a non-adherent dressing to the perianal abscess cavity.

Treatment:

Other: External dressing