Packing of Perianal Abscess Cavities
PPAC2
The Impact of Postoperative Packing of Perianal Abscess Cavities: a Multicentre Randomised Controlled Trial
2 other identifiers
interventional
433
1 country
50
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2018
Typical duration for not_applicable
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2017
CompletedFirst Posted
Study publicly available on registry
October 20, 2017
CompletedStudy Start
First participant enrolled
February 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 12, 2020
CompletedSeptember 9, 2020
September 1, 2020
2.3 years
October 11, 2017
September 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (14)
Dressing-change related pain intensity
First 10 post-operative days
Health related quality of life
On the 21st post-operative day
Health utility
On the 21st post-operative day
Patient satisfaction with wound management
On the 21st post-operative day
Rate of wound healing
Four and eight weeks post-operatively
- +9 more secondary outcomes
Study Arms (2)
Packing of perianal abscess cavity
ACTIVE COMPARATORInternal packing of perianal abscess cavity as per normal practice.
External dressing
EXPERIMENTALExternal application of a non-adherent dressing to the perianal abscess cavity.
Interventions
Application of external dressing whilst perianal abscess cavity heals.
Internal packing of perianal abscess cavity - standard treatment.
Eligibility Criteria
You may qualify if:
- Aged 18 or over
- Undergoing surgical incision and drainage of a primary perianal abscess
You may not qualify if:
- Suspected inflammatory bowel disease
- Fournier's Gangrene
- Horseshoe (bilateral) abscess
- Fistula-in-ano
- Multiple abscess
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Manchester University NHS Foundation Trustlead
- University of Liverpoolcollaborator
- Northwest Research Collaborativecollaborator
- University of Birminghamcollaborator
- National Institute for Health Research, United Kingdomcollaborator
Study Sites (50)
Salford Royal Hospital
Salford, Greater Manchester, M6 8HD, United Kingdom
West Middlesex University Hospital (Isleworth)
Isleworth, Middlesex, TW7 6AF, United Kingdom
John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DZ, United Kingdom
Mew Cross Hospital
Wolverhampton, West Midlands, WV10 0QP, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, West Yorkshire, HD3 3EA, United Kingdom
Pindersfields General Hospital
Wakefield, West Yorkshire, WF1 4DS, United Kingdom
Salisbury District Hospital
Salisbury, Wiltshire, SP2 8BJ, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
Bangor Hospital, Betsi Cadwaladr University Health Board
Bangor, United Kingdom
Furness General Hospital
Barrow in Furness, United Kingdom
Royal United Hospital Bath NHS Foundation Trust
Bath, United Kingdom
Birmingham Heartlands Hospital
Birmingham, United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham, United Kingdom
Royal Blackburn Hospital
Blackburn, United Kingdom
Blackpool Victoria Hospital
Blackpool, United Kingdom
Royal Bolton Hospital
Bolton, United Kingdom
Bristol royal Infirmary, University Hospitals Bristol
Bristol, United Kingdom
Southmead Hospital North Bristo; NHS Trust
Bristol, United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom
University Hospital of Wales (Cardiff)
Cardiff, United Kingdom
Broomfield Hospital
Chelmsford, United Kingdom
Countess of Chester
Chester, CH2 1UL, United Kingdom
Chesterfield Royal Hospital NHS Foundation Trust
Chesterfield, United Kingdom
University Hospitals Coventry and Warwickshire
Coventry, United Kingdom
Royal Devon & Exeter Hospital
Exeter, United Kingdom
Victoria Hospital (Fife)
Kirkcaldy, United Kingdom
Royal Lancaster Infirmary
Lancaster, United Kingdom
Aintree Hospital
Liverpool, United Kingdom
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Liverpool, United Kingdom
Royal Glamorgan Hospital
Llantrisant, United Kingdom
Macclesfield District General Hospital
Macclesfield, United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom
Wythenshawe Hospital
Manchester, United Kingdom
Queen Elizabeth The Queen Mother Hospital
Margate, United Kingdom
Newcastle Upon Tyne University Hospitals NHS Foundation Trust
Newcastle, United Kingdom
Royal Gwent Hospital
Newport, United Kingdom
Norfolk and Norwich University Hospital
Norwich, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Royal Alexandra Hospital
Paisley, United Kingdom
Plymouth Hospitals NHS Trust Derriford Hospital
Plymouth, United Kingdom
Portsmouth Hospitals NHS Trust
Portsmouth, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
Arrowe Park Hospital
Upton, United Kingdom
Warrington Hospital
Warrington, United Kingdom
Warwick Hospital, South Warwickshire NHS Foundation Trust
Warwick, United Kingdom
Sandwell Hospital, SWBH NHS Trust
West Bromwich, United Kingdom
Royal Albert and Edward Infirmary
Wigan, United Kingdom
Wrexham Maelor Hospital, Betsi Cadwaladr University Health Board
Wrexham, United Kingdom
Yeovil District Hospital
Yeovil, United Kingdom
Related Publications (3)
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.
PMID: 27562822BACKGROUNDPearce 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.
PMID: 27061287BACKGROUNDNewton 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.
PMID: 35929816DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Hill, FRCS
Manchester University NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Note that only the clinician assessing healing and fistulae are masked.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2017
First Posted
October 20, 2017
Study Start
February 14, 2018
Primary Completion
June 12, 2020
Study Completion
June 12, 2020
Last Updated
September 9, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share