Packing of Perianal Abscess Cavities (PPAC2)

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

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.

Study Overview

• Status: Completed
• Conditions: Perianal Abscess; Perianal Infections; Peri Rectal Abscess; Abscess; Anus; Abscess Anorectal
• Intervention / Treatment: Other: Packing of perianal abscess cavity; Other: External dressing

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.

• Study Type: Interventional
• Enrollment (Actual): 433
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Aberdeen, United Kingdom
    • Aberdeen Royal Infirmary
  • Bangor, United Kingdom
    • Bangor Hospital, Betsi Cadwaladr University Health Board
  • Barrow In Furness, United Kingdom
    • Furness General Hospital
  • Bath, United Kingdom
    • Royal United Hospital Bath NHS Foundation Trust
  • Birmingham, United Kingdom
    • Birmingham Heartlands Hospital
  • Birmingham, United Kingdom
    • Queen Elizabeth Hospital Birmingham
  • Blackburn, United Kingdom
    • Royal Blackburn Hospital
  • Blackpool, United Kingdom
    • Blackpool Victoria Hospital
  • Bolton, United Kingdom
    • Royal Bolton Hospital
  • Bristol, United Kingdom
    • Bristol royal Infirmary, University Hospitals Bristol
  • Bristol, United Kingdom
    • Southmead Hospital North Bristo; NHS Trust
  • Cambridge, United Kingdom
    • Addenbrooke's Hospital
  • Cardiff, United Kingdom
    • University Hospital of Wales (Cardiff)
  • Chelmsford, United Kingdom
    • Broomfield Hospital
  • Chester, United Kingdom, CH2 1UL
    • Countess of Chester
  • Chesterfield, United Kingdom
    • Chesterfield Royal Hospital NHS Foundation Trust
  • Coventry, United Kingdom
    • University Hospitals Coventry and Warwickshire
  • Exeter, United Kingdom
    • Royal Devon & Exeter Hospital
  • Kirkcaldy, United Kingdom
    • Victoria Hospital (Fife)
  • Lancaster, United Kingdom
    • Royal Lancaster Infirmary
  • Liverpool, United Kingdom
    • Royal Liverpool and Broadgreen University Hospitals NHS Trust
  • Liverpool, United Kingdom
    • Aintree Hospital
  • Llantrisant, United Kingdom
    • Royal Glamorgan Hospital
  • Macclesfield, United Kingdom
    • Macclesfield District General Hospital
  • Manchester, United Kingdom
    • Manchester Royal Infirmary
  • Manchester, United Kingdom
    • Wythenshawe Hospital
  • Margate, United Kingdom
    • Queen Elizabeth the Queen Mother Hospital
  • Newcastle, United Kingdom
    • Newcastle Upon Tyne University Hospitals NHS Foundation Trust
  • Newport, United Kingdom
    • Royal Gwent Hospital
  • Norwich, United Kingdom
    • Norfolk and Norwich University Hospital
  • Nottingham, United Kingdom
    • Nottingham University Hospitals Nhs Trust
  • Paisley, United Kingdom
    • Royal Alexandra Hospital
  • Plymouth, United Kingdom
    • Plymouth Hospitals NHS Trust Derriford Hospital
  • Portsmouth, United Kingdom
    • Portsmouth Hospitals NHS Trust
  • Sheffield, United Kingdom
    • Sheffield Teaching Hospitals NHS Foundation Trust
  • Southampton, United Kingdom
    • Southampton General Hospital
  • Upton, United Kingdom
    • Arrowe Park Hospital
  • Warrington, United Kingdom
    • Warrington Hospital
  • Warwick, United Kingdom
    • Warwick Hospital, South Warwickshire NHS Foundation Trust
  • West Bromwich, United Kingdom
    • Sandwell Hospital, SWBH NHS Trust
  • Wigan, United Kingdom
    • Royal Albert and Edward Infirmary
  • Wrexham, United Kingdom
    • Wrexham Maelor Hospital, Betsi Cadwaladr University Health Board
  • Yeovil, United Kingdom
    • Yeovil District Hospital
  • Greater Manchester
    • Salford, Greater Manchester, United Kingdom, M6 8HD
      • Salford Royal Hospital
  • Middlesex
    • Isleworth, Middlesex, United Kingdom, TW7 6AF
      • West Middlesex University Hospital (Isleworth)
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 9DZ
      • John Radcliffe Hospital
  • West Midlands
    • Wolverhampton, West Midlands, United Kingdom, WV10 0QP
      • Mew Cross Hospital
  • West Yorkshire
    • Huddersfield, West Yorkshire, United Kingdom, HD3 3EA
      • Huddersfield Royal Infirmary
    • Wakefield, West Yorkshire, United Kingdom, WF1 4DS
      • Pindersfields General Hospital
  • Wiltshire
    • Salisbury, Wiltshire, United Kingdom, SP2 8BJ
      • Salisbury District Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Packing of perianal abscess cavity; Internal packing of perianal abscess cavity as per normal practice.	Other: Packing of perianal abscess cavity; Internal packing of perianal abscess cavity - standard treatment.
Experimental: External dressing; External application of a non-adherent dressing to the perianal abscess cavity.	Other: External dressing; Application of external dressing whilst perianal abscess cavity heals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound-related pain intensity	Wound-related pain intensity (worst pain during previous 24 hours) measured using a single 100mm Visual Analogue Scale where 0 represents 'no pain' and 100 represents 'worst pain possible'. The pain Visual Analogue Scale is a continuous scale comprised of a horizontal line 100mm in length, anchored by 2 verbal descriptors, one for each symptom extreme, where 0 represents 'no pain' and 100 represents 'worst pain possible'. The mean score over the first 10 post-operative days will be used.	Mean score over first 10 post-operative days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dressing-change related pain intensity	Pain before, during and after dressing change measured using a 100mm Visual Analogue Scale where 0 represents 'no pain' and 100 represents 'worst pain possible'. The pain Visual Analogue Scale is a continuous scale comprised of a horizontal line 100 mm in length, anchored by 2 verbal descriptors, one for each symptom extreme. The mean score for each timepoint (before, during and after) over the first 10 post-operative days will be used.	First 10 post-operative days
Health related quality of life	Health related quality of life measured using EuroQol EQ-5D-5L quality of life questionnaires. The EQ-5D-5L descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension now has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state.	On the 21st post-operative day
Health utility	Health utility measured using EuroQol EQ-5D-5L quality of life questionnaires. The EQ-5D-5L descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension now has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state.	On the 21st post-operative day
Patient satisfaction with wound management	Patient satisfaction with wound management measured using a five point Likert scale. Patients are asked to mark the extent to which they agree with the statement 'I am satisfied with the way my wound has been treated following my surgery' where 1 equates to 'strongly disagree' and 5 equates to 'strongly agree'.	On the 21st post-operative day
Rate of wound healing	Rate of wound healing (complete epithelialization)	Four and eight weeks post-operatively
Clinical diagnosis of perianal abscesses recurrence after healing	Clinical diagnosis of perianal abscesses recurrence after healing, ascertained either through clinical follow-up as part of trial procedures or via central National Health Service registries.	52 weeks post-operatively
Chronic post-surgical pain	Chronic post-surgical pain measured using the Brief Pain Inventory - Short Form. The Brief Pain Inventory - Short Form assesses the severity of pain and the impact on daily functions. Pain is assessed at its "worst," "least," "average," and "now" (current pain), measured on a scale of 1-10 where 1 represents "no pain" and 10 represents "pain as bad as you can imagine". The four items will be represented singly but a composite of the four pain items (a mean score) will be presented as supplemental information. Pain interference (impact of pain on seven daily activities) will be scored as the mean of the seven interference items. These items are scored between 1 and 10, where 1 represents "does not interfere" and 10 represents "completely interferes".	4, 8 and 26 weeks post-operatively
Dressing use	Number of dressings used between time of operation up until week 52.	Up to 52 weeks post-operatively
Health Professional contact time	Number of contacts with a Health Professional regarding perianal abscess or post-surgical complications between time of operation and 52 weeks post-operatively.	Up to 52 weeks post-operatively
Hospital admission time	Number and length of hospital admissions as recorded in NHS central registries - Hospital Episodes Statistics.	Up to 52 weeks post-operatively
Time to return to work or normal function	Length of time, measured in days, between operation and return to work or normal function.	Up to 52 weeks post-operatively
Cost	Cost as applied to resource use data (see outcome 9-12)	Up to 52 weeks post-operatively
Assessment of pain control methods	Assessment of pain control methods (i.e. pain control medications) using Patient Global Assessment of the method of pain control where a rating of the pain control method over the past 24 hours is rated as being one of "poor," "fair," "good," or "excellent".	21 days post-operatively
Fistula rate	Fistula rate observed during clinical follow up and through Hospital Episodes Statistics	Up ro 52 weeks post-operatively

Collaborators and Investigators

• Sponsor: Manchester University NHS Foundation Trust
• Collaborators: University of Liverpool; University of Birmingham; National Institute for Health Research, United Kingdom; Northwest Research Collaborative
• Investigators: Principal Investigator: James Hill, FRCS, Manchester University NHS Foundation Trust

Publications and helpful links

General Publications

• Smith SR, Newton K, Smith JA, Dumville JC, Iheozor-Ejiofor Z, Pearce LE, Barrow PJ, Hancock L, Hill J. Internal dressings for healing perianal abscess cavities. Cochrane Database Syst Rev. 2016 Aug 26;2016(8):CD011193. doi: 10.1002/14651858.CD011193.pub2.
• Pearce L, Newton K, Smith SR, Barrow P, Smith J, Hancock L, Kirwan CC, Hill J; North West Research Collaborative. Multicentre observational study of outcomes after drainage of acute perianal abscess. Br J Surg. 2016 Jul;103(8):1063-8. doi: 10.1002/bjs.10154. Epub 2016 Apr 7.
• Newton K, Dumville J, Briggs M, Law J, Martin J, Pearce L, Kirwan C, Pinkney T, Needham A, Jackson R, Winn S, McCulloch H, Hill J; PPAC2 Collaborators. Postoperative Packing of Perianal Abscess Cavities (PPAC2): randomized clinical trial. Br J Surg. 2022 Sep 9;109(10):951-957. doi: 10.1093/bjs/znac225.

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2018
• Primary Completion (Actual): June 12, 2020
• Study Completion (Actual): June 12, 2020

Study Registration Dates

• First Submitted: October 11, 2017
• First Submitted That Met QC Criteria: October 16, 2017
• First Posted (Actual): October 20, 2017

Study Record Updates

• Last Update Posted (Actual): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Incision and Drainage; Packing
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Suppuration; Abscess
• Other Study ID Numbers: R04689; PB-PG-0815-20037 (Other Grant/Funding Number: NIHR RfPB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No