Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
433 participants
INTERVENTIONAL
2018-02-14
2020-06-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Association of Intestinal Microbiota and the Onset of Perianal Abscess Based on 16S RDNA Amplicon Sequencing
NCT05862129
Antibiotic Therapy of Acute Uncomplicated Colonic Diverticulitis
NCT01008488
Appendicoliths in Acute Complicated Appendicitis Patients With Abscess
NCT06469086
Antibiotics vs. Placebo in Acute Uncomplicated Appendicitis
NCT03234296
Acute Appendicitis and Microbiota - Etiology of Appendicitis and Antibiotic Therapy Effects
NCT03257423
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Packing of perianal abscess cavity
Internal packing of perianal abscess cavity as per normal practice.
Packing of perianal abscess cavity
Internal packing of perianal abscess cavity - standard treatment.
External dressing
External application of a non-adherent dressing to the perianal abscess cavity.
External dressing
Application of external dressing whilst perianal abscess cavity heals.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
External dressing
Application of external dressing whilst perianal abscess cavity heals.
Packing of perianal abscess cavity
Internal packing of perianal abscess cavity - standard treatment.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Undergoing surgical incision and drainage of a primary perianal abscess
Exclusion Criteria
2. Fournier's Gangrene
3. Horseshoe (bilateral) abscess
4. Fistula-in-ano
5. Multiple abscess
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Liverpool
OTHER
Northwest Research Collaborative
UNKNOWN
University of Birmingham
OTHER
National Institute for Health Research, United Kingdom
OTHER_GOV
Manchester University NHS Foundation Trust
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
James Hill, FRCS
Role: PRINCIPAL_INVESTIGATOR
Manchester University NHS Foundation Trust
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Salford Royal Hospital
Salford, Greater Manchester, United Kingdom
West Middlesex University Hospital (Isleworth)
Isleworth, Middlesex, United Kingdom
John Radcliffe Hospital
Oxford, Oxfordshire, United Kingdom
Mew Cross Hospital
Wolverhampton, West Midlands, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, West Yorkshire, United Kingdom
Pindersfields General Hospital
Wakefield, West Yorkshire, United Kingdom
Salisbury District Hospital
Salisbury, Wiltshire, 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, , 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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PB-PG-0815-20037
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
R04689
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.