Perianal AbscessPPAC2NCT03315169
Packing of Perianal Abscess Cavities
A study testing External dressing and Packing of perianal abscess cavity in people with Perianal Abscess and Perianal Infections, run by Manchester University NHS Foundation Trust at 50 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perianal Abscess, Perianal Infections, Peri Rectal Abscess
- What is being tested?
- External dressing and Packing of perianal abscess cavity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 433 participants
- Where
- 50 sitesUnited Kingdom
- Study dates
- 14 Feb 2018to 12 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 or over
- Undergoing surgical incision and drainage of a primary perianal abscess
Who cannot join
- Suspected inflammatory bowel disease
- Fournier's Gangrene
- Horseshoe (bilateral) abscess
- Fistula-in-ano
- Multiple abscess
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
United Kingdom50 sites
Aberdeen Royal Infirmary
Aberdeen
Bangor Hospital, Betsi Cadwaladr University Health Board
Bangor
Furness General Hospital
Barrow in Furness
Royal United Hospital Bath NHS Foundation Trust
Bath
Birmingham Heartlands Hospital
Birmingham
Queen Elizabeth Hospital Birmingham
Birmingham
Royal Blackburn Hospital
Blackburn
Blackpool Victoria Hospital
Blackpool
Royal Bolton Hospital
Bolton
Bristol royal Infirmary, University Hospitals Bristol
Bristol
Southmead Hospital North Bristo; NHS Trust
Bristol
Addenbrooke's Hospital
Cambridge
University Hospital of Wales (Cardiff)
Cardiff
Broomfield Hospital
Chelmsford
Countess of Chester
Chester, CH2 1UL
Chesterfield Royal Hospital NHS Foundation Trust
Chesterfield
University Hospitals Coventry and Warwickshire
Coventry
Royal Devon & Exeter Hospital
Exeter
Huddersfield Royal Infirmary
Huddersfield, West Yorkshire, HD3 3EA
West Middlesex University Hospital (Isleworth)
Isleworth, Middlesex, TW7 6AF
Victoria Hospital (Fife)
Kirkcaldy
Royal Lancaster Infirmary
Lancaster
Aintree Hospital
Liverpool
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Liverpool
Royal Glamorgan Hospital
Llantrisant
Macclesfield District General Hospital
Macclesfield
Manchester Royal Infirmary
Manchester
Wythenshawe Hospital
Manchester
Queen Elizabeth The Queen Mother Hospital
Margate
Newcastle Upon Tyne University Hospitals NHS Foundation Trust
Newcastle
Royal Gwent Hospital
Newport
Norfolk and Norwich University Hospital
Norwich
Nottingham University Hospitals NHS Trust
Nottingham
John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DZ
Royal Alexandra Hospital
Paisley
Plymouth Hospitals NHS Trust Derriford Hospital
Plymouth
Portsmouth Hospitals NHS Trust
Portsmouth
Salford Royal Hospital
Salford, Greater Manchester, M6 8HD
Salisbury District Hospital
Salisbury, Wiltshire, SP2 8BJ
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield
Southampton General Hospital
Southampton
Arrowe Park Hospital
Upton
Pindersfields General Hospital
Wakefield, West Yorkshire, WF1 4DS
Warrington Hospital
Warrington
Warwick Hospital, South Warwickshire NHS Foundation Trust
Warwick
Sandwell Hospital, SWBH NHS Trust
West Bromwich
Royal Albert and Edward Infirmary
Wigan
Mew Cross Hospital
Wolverhampton, West Midlands, WV10 0QP
Wrexham Maelor Hospital, Betsi Cadwaladr University Health Board
Wrexham
Yeovil District Hospital
Yeovil
About this study
Official title: 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.
Read the 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.
- Conditions
- Perianal Abscess, Perianal Infections, Peri Rectal Abscess, Abscess; Anus, Abscess Anorectal
- Being tested
- External dressing, Packing of perianal abscess cavity
- Keywords
- Incision and Drainage, Packing
- Medical subject headings
- Abscess, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External dressingOther
Application of external dressing whilst perianal abscess cavity heals.
Packing of perianal abscess cavityOther
Internal packing of perianal abscess cavity - standard treatment.
| Study group | Role | What they receive |
|---|---|---|
| Packing of perianal abscess cavity | Active comparator | Internal packing of perianal abscess cavity as per normal practice. Receives: Other: Packing of perianal abscess cavity |
| External dressing | Experimental | External application of a non-adherent dressing to the perianal abscess cavity. Receives: Other: External dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Mean score over first 10 post-operative days
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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'.
Measured: On the 21st post-operative day
Rate of wound healing
Rate of wound healing (complete epithelialization)
Measured: 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.
Measured: 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".
Measured: 4, 8 and 26 weeks post-operatively
Dressing use
Number of dressings used between time of operation up until week 52.
Measured: 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.
Measured: Up to 52 weeks post-operatively
Hospital admission time
Number and length of hospital admissions as recorded in NHS central registries - Hospital Episodes Statistics.
Measured: 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.
Measured: Up to 52 weeks post-operatively
Cost
Cost as applied to resource use data (see outcome 9-12)
Measured: 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".
Measured: 21 days post-operatively
Fistula rate
Fistula rate observed during clinical follow up and through Hospital Episodes Statistics
Measured: Up ro 52 weeks post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start14 Feb 2018
- Primary completion12 Jun 2020
- Study completion12 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Perianal AbscessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 433 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- University of Liverpool, Northwest Research Collaborative, University of Birmingham, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- James Hill, FRCS, Principal investigator, Manchester University NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315169
- Sponsor's protocol ID
- R04689
- Other IDs
- PB-PG-0815-20037
- Acronym
- PPAC2
- Status last verified
- Sep 2020
- First submitted
- 11 Oct 2017
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27562822Pearce 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.
PubMed 27061287Newton 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.
PubMed 35929816
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Postoperative Packing of Perianal Abscess Cavities: a Multicentre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03315169
- Acronym / sponsor ID
- PPAC2 / R04689
- Conditions
- Perianal Abscess, Perianal Infections, Peri Rectal Abscess, Abscess; Anus, Abscess Anorectal
- Keywords
- Incision and Drainage, Packing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 433 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- University of Liverpool, Northwest Research Collaborative, University of Birmingham, National Institute for Health Research, United Kingdom
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 12 Jun 2020 (actual)
- Study completion
- 12 Jun 2020 (actual)
- First posted
- 20 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Packing of perianal abscess cavity | Active comparator | Other: Packing of perianal abscess cavityInternal packing of perianal abscess cavity as per normal practice. |
| External dressing | Experimental | Other: External dressingExternal application of a non-adherent dressing to the perianal abscess cavity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18 or over
- Undergoing surgical incision and drainage of a primary perianal abscess
Key exclusion criteria (5 listed)
- Suspected inflammatory bowel disease
- Fournier's Gangrene
- Horseshoe (bilateral) abscess
- Fistula-in-ano
- Multiple abscess
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External dressingApplication of external dressing whilst perianal abscess cavity heals. | Other | External dressing |
| Packing of perianal abscess cavityInternal packing of perianal abscess cavity - standard treatment. | Other | Packing of perianal abscess cavity |
Primary outcome
Wound-related pain intensity
Time frame: Mean score over first 10 post-operative days
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.
14 secondary outcomes
Dressing-change related pain intensity
Time frame: First 10 post-operative days
Health related quality of life
Time frame: On the 21st post-operative day
Health utility
Time frame: On the 21st post-operative day
Patient satisfaction with wound management
Time frame: On the 21st post-operative day
Rate of wound healing
Time frame: Four and eight weeks post-operatively
Clinical diagnosis of perianal abscesses recurrence after healing
Time frame: 52 weeks post-operatively
Chronic post-surgical pain
Time frame: 4, 8 and 26 weeks post-operatively
Dressing use
Time frame: Up to 52 weeks post-operatively
Health Professional contact time
Time frame: Up to 52 weeks post-operatively
Hospital admission time
Time frame: Up to 52 weeks post-operatively
Time to return to work or normal function
Time frame: Up to 52 weeks post-operatively
Cost
Time frame: Up to 52 weeks post-operatively
Assessment of pain control methods
Time frame: 21 days post-operatively
Fistula rate
Time frame: Up ro 52 weeks post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Background: PubMed 27562822Smith 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.
- Background: PubMed 27061287Pearce 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.
- Derived from this study: PubMed 35929816Newton 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Hill, FRCS principal investigator
Manchester University NHS Foundation Trust
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External dressing and Packing of perianal abscess cavity in people with Perianal Abscess and Perianal Infections, run by Manchester University NHS Foundation Trust at 50 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound-related pain intensity (time frame: Mean score over first 10 post-operative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03315169, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.