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Packing of Perianal Abscess Cavities (PPAC2)

Primary Purpose

Perianal Abscess, Perianal Infections, Peri Rectal Abscess

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
External dressing
Packing of perianal abscess cavity
Sponsored by
Manchester University NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perianal Abscess focused on measuring Incision and Drainage, Packing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Salford Royal Hospital
  • West Middlesex University Hospital (Isleworth)
  • John Radcliffe Hospital
  • Mew Cross Hospital
  • Huddersfield Royal Infirmary
  • Pindersfields General Hospital
  • Salisbury District Hospital
  • Aberdeen Royal Infirmary
  • Bangor Hospital, Betsi Cadwaladr University Health Board
  • Furness General Hospital
  • Royal United Hospital Bath NHS Foundation Trust
  • Birmingham Heartlands Hospital
  • Queen Elizabeth Hospital Birmingham
  • Royal Blackburn Hospital
  • Blackpool Victoria Hospital
  • Royal Bolton Hospital
  • Bristol royal Infirmary, University Hospitals Bristol
  • Southmead Hospital North Bristo; NHS Trust
  • Addenbrooke's Hospital
  • University Hospital of Wales (Cardiff)
  • Broomfield Hospital
  • Chesterfield Royal Hospital NHS Foundation Trust
  • Countess of Chester
  • University Hospitals Coventry and Warwickshire
  • Royal Devon & Exeter Hospital
  • Victoria Hospital (Fife)
  • Royal Lancaster Infirmary
  • Aintree Hospital
  • Royal Liverpool and Broadgreen University Hospitals NHS Trust
  • Royal Glamorgan Hospital
  • Macclesfield District General Hospital
  • Manchester Royal Infirmary
  • Wythenshawe Hospital
  • Queen Elizabeth The Queen Mother Hospital
  • Newcastle Upon Tyne University Hospitals NHS Foundation Trust
  • Royal Gwent Hospital
  • Norfolk and Norwich University Hospital
  • Nottingham University Hospitals NHS Trust
  • Royal Alexandra Hospital
  • Plymouth Hospitals NHS Trust Derriford Hospital
  • Portsmouth Hospitals NHS Trust
  • Sheffield Teaching Hospitals NHS Foundation Trust
  • Southampton General Hospital
  • Arrowe Park Hospital
  • Warrington Hospital
  • Warwick Hospital, South Warwickshire NHS Foundation Trust
  • Sandwell Hospital, SWBH NHS Trust
  • Royal Albert and Edward Infirmary
  • Wrexham Maelor Hospital, Betsi Cadwaladr University Health Board
  • Yeovil District Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Packing of perianal abscess cavity

External dressing

Arm Description

Internal packing of perianal abscess cavity as per normal practice.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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'.
Rate of wound healing
Rate of wound healing (complete epithelialization)
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.
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".
Dressing use
Number of dressings used between time of operation up until week 52.
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.
Hospital admission time
Number and length of hospital admissions as recorded in NHS central registries - Hospital Episodes Statistics.
Time to return to work or normal function
Length of time, measured in days, between operation and return to work or normal function.
Cost
Cost as applied to resource use data (see outcome 9-12)
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".
Fistula rate
Fistula rate observed during clinical follow up and through Hospital Episodes Statistics

Full Information

First Posted
October 11, 2017
Last Updated
September 8, 2020
Sponsor
Manchester University NHS Foundation Trust
Collaborators
University of Liverpool, Northwest Research Collaborative, University of Birmingham, National Institute for Health Research, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT03315169
Brief Title
Packing of Perianal Abscess Cavities
Acronym
PPAC2
Official Title
The Impact of Postoperative Packing of Perianal Abscess Cavities: a Multicentre Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 14, 2018 (Actual)
Primary Completion Date
June 12, 2020 (Actual)
Study Completion Date
June 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Manchester University NHS Foundation Trust
Collaborators
University of Liverpool, Northwest Research Collaborative, University of Birmingham, National Institute for Health Research, United Kingdom

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perianal Abscess, Perianal Infections, Peri Rectal Abscess, Abscess; Anus, Abscess Anorectal
Keywords
Incision and Drainage, Packing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Note that only the clinician assessing healing and fistulae are masked.
Allocation
Randomized
Enrollment
433 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Packing of perianal abscess cavity
Arm Type
Active Comparator
Arm Description
Internal packing of perianal abscess cavity as per normal practice.
Arm Title
External dressing
Arm Type
Experimental
Arm Description
External application of a non-adherent dressing to the perianal abscess cavity.
Intervention Type
Other
Intervention Name(s)
External dressing
Intervention Description
Application of external dressing whilst perianal abscess cavity heals.
Intervention Type
Other
Intervention Name(s)
Packing of perianal abscess cavity
Intervention Description
Internal packing of perianal abscess cavity - standard treatment.
Primary Outcome Measure Information:
Title
Wound-related pain intensity
Description
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.
Time Frame
Mean score over first 10 post-operative days
Secondary Outcome Measure Information:
Title
Dressing-change related pain intensity
Description
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.
Time Frame
First 10 post-operative days
Title
Health related quality of life
Description
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.
Time Frame
On the 21st post-operative day
Title
Health utility
Description
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.
Time Frame
On the 21st post-operative day
Title
Patient satisfaction with wound management
Description
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'.
Time Frame
On the 21st post-operative day
Title
Rate of wound healing
Description
Rate of wound healing (complete epithelialization)
Time Frame
Four and eight weeks post-operatively
Title
Clinical diagnosis of perianal abscesses recurrence after healing
Description
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.
Time Frame
52 weeks post-operatively
Title
Chronic post-surgical pain
Description
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".
Time Frame
4, 8 and 26 weeks post-operatively
Title
Dressing use
Description
Number of dressings used between time of operation up until week 52.
Time Frame
Up to 52 weeks post-operatively
Title
Health Professional contact time
Description
Number of contacts with a Health Professional regarding perianal abscess or post-surgical complications between time of operation and 52 weeks post-operatively.
Time Frame
Up to 52 weeks post-operatively
Title
Hospital admission time
Description
Number and length of hospital admissions as recorded in NHS central registries - Hospital Episodes Statistics.
Time Frame
Up to 52 weeks post-operatively
Title
Time to return to work or normal function
Description
Length of time, measured in days, between operation and return to work or normal function.
Time Frame
Up to 52 weeks post-operatively
Title
Cost
Description
Cost as applied to resource use data (see outcome 9-12)
Time Frame
Up to 52 weeks post-operatively
Title
Assessment of pain control methods
Description
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".
Time Frame
21 days post-operatively
Title
Fistula rate
Description
Fistula rate observed during clinical follow up and through Hospital Episodes Statistics
Time Frame
Up ro 52 weeks post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18 or over Undergoing surgical incision and drainage of a primary perianal abscess Exclusion Criteria: Suspected inflammatory bowel disease Fournier's Gangrene Horseshoe (bilateral) abscess Fistula-in-ano Multiple abscess
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Hill, FRCS
Organizational Affiliation
Manchester University NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Salford Royal Hospital
City
Salford
State/Province
Greater Manchester
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
West Middlesex University Hospital (Isleworth)
City
Isleworth
State/Province
Middlesex
ZIP/Postal Code
TW7 6AF
Country
United Kingdom
Facility Name
John Radcliffe Hospital
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DZ
Country
United Kingdom
Facility Name
Mew Cross Hospital
City
Wolverhampton
State/Province
West Midlands
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Facility Name
Huddersfield Royal Infirmary
City
Huddersfield
State/Province
West Yorkshire
ZIP/Postal Code
HD3 3EA
Country
United Kingdom
Facility Name
Pindersfields General Hospital
City
Wakefield
State/Province
West Yorkshire
ZIP/Postal Code
WF1 4DS
Country
United Kingdom
Facility Name
Salisbury District Hospital
City
Salisbury
State/Province
Wiltshire
ZIP/Postal Code
SP2 8BJ
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
Country
United Kingdom
Facility Name
Bangor Hospital, Betsi Cadwaladr University Health Board
City
Bangor
Country
United Kingdom
Facility Name
Furness General Hospital
City
Barrow In Furness
Country
United Kingdom
Facility Name
Royal United Hospital Bath NHS Foundation Trust
City
Bath
Country
United Kingdom
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital Birmingham
City
Birmingham
Country
United Kingdom
Facility Name
Royal Blackburn Hospital
City
Blackburn
Country
United Kingdom
Facility Name
Blackpool Victoria Hospital
City
Blackpool
Country
United Kingdom
Facility Name
Royal Bolton Hospital
City
Bolton
Country
United Kingdom
Facility Name
Bristol royal Infirmary, University Hospitals Bristol
City
Bristol
Country
United Kingdom
Facility Name
Southmead Hospital North Bristo; NHS Trust
City
Bristol
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
Country
United Kingdom
Facility Name
University Hospital of Wales (Cardiff)
City
Cardiff
Country
United Kingdom
Facility Name
Broomfield Hospital
City
Chelmsford
Country
United Kingdom
Facility Name
Chesterfield Royal Hospital NHS Foundation Trust
City
Chesterfield
Country
United Kingdom
Facility Name
Countess of Chester
City
Chester
ZIP/Postal Code
CH2 1UL
Country
United Kingdom
Facility Name
University Hospitals Coventry and Warwickshire
City
Coventry
Country
United Kingdom
Facility Name
Royal Devon & Exeter Hospital
City
Exeter
Country
United Kingdom
Facility Name
Victoria Hospital (Fife)
City
Kirkcaldy
Country
United Kingdom
Facility Name
Royal Lancaster Infirmary
City
Lancaster
Country
United Kingdom
Facility Name
Aintree Hospital
City
Liverpool
Country
United Kingdom
Facility Name
Royal Liverpool and Broadgreen University Hospitals NHS Trust
City
Liverpool
Country
United Kingdom
Facility Name
Royal Glamorgan Hospital
City
Llantrisant
Country
United Kingdom
Facility Name
Macclesfield District General Hospital
City
Macclesfield
Country
United Kingdom
Facility Name
Manchester Royal Infirmary
City
Manchester
Country
United Kingdom
Facility Name
Wythenshawe Hospital
City
Manchester
Country
United Kingdom
Facility Name
Queen Elizabeth The Queen Mother Hospital
City
Margate
Country
United Kingdom
Facility Name
Newcastle Upon Tyne University Hospitals NHS Foundation Trust
City
Newcastle
Country
United Kingdom
Facility Name
Royal Gwent Hospital
City
Newport
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospital
City
Norwich
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
Country
United Kingdom
Facility Name
Royal Alexandra Hospital
City
Paisley
Country
United Kingdom
Facility Name
Plymouth Hospitals NHS Trust Derriford Hospital
City
Plymouth
Country
United Kingdom
Facility Name
Portsmouth Hospitals NHS Trust
City
Portsmouth
Country
United Kingdom
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust
City
Sheffield
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
Country
United Kingdom
Facility Name
Arrowe Park Hospital
City
Upton
Country
United Kingdom
Facility Name
Warrington Hospital
City
Warrington
Country
United Kingdom
Facility Name
Warwick Hospital, South Warwickshire NHS Foundation Trust
City
Warwick
Country
United Kingdom
Facility Name
Sandwell Hospital, SWBH NHS Trust
City
West Bromwich
Country
United Kingdom
Facility Name
Royal Albert and Edward Infirmary
City
Wigan
Country
United Kingdom
Facility Name
Wrexham Maelor Hospital, Betsi Cadwaladr University Health Board
City
Wrexham
Country
United Kingdom
Facility Name
Yeovil District Hospital
City
Yeovil
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27562822
Citation
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.
Results Reference
background
PubMed Identifier
27061287
Citation
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.
Results Reference
background
PubMed Identifier
35929816
Citation
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.
Results Reference
derived

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Packing of Perianal Abscess Cavities

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