Condition category
Digestive System
Date applied
23/10/2017
Date assigned
01/11/2017
Last edited
01/11/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
A perianal abscess is an infection close to the back passage (anus). It occurs in thousands of UK patients every year. Standard treatment is a small operation under general anaesthetic when an opening is made in the abscess to let out the infection. The usual treatment is then to place a dressing into the wound (packing). The wound pack is changed every one to two days. Packing has traditionally been used as it is thought to aid healing. However, packing wounds is painful and a small study has suggested that packing may not help wound healing. The aim of this study is to answer whether simple dressings on the wound surface are better than traditional packing into the wound on patients after drainage of a perianal abscess.

Who can participate?
Adults aged 18 and older who are undergoing surgical incision and drainage of a primary perianal abscess.

What does the study involve?
All participants undergo the operation they require to incise and drain their perianal abscess. This cavity will have an internal dressing placed into it at the end of the surgery to help reduce bleeding. This is standard practice and would occur outside of this study. Participants are then randomly allocated to one of two groups. Those in the first group then have the removal of the internal dressing (packing) after 24 hours and continuing dressings provided for over the wound only. No internal dressings will then be used. Those in the second group have the change of the internal dressing (packing) after 24 hours and on-going regular changes of the internal dressing (packing) in the community (standard treatment). All participants are asked to complete a diary over the first 10 days to record their pain, quality of life and comments at various steps during the treatment of the wound. Additional diary entries are completed at 14 and 21 days after the operation. Patients are also contacted by phone to assess whether they have returned to work or normal function. All participants attend an outpatient appointment at four weeks, eight weeks (only if the wound has not healed) and 26 weeks after the procedure to assess the wound and look for evidence of a fistula (a tunnel under the skin from the back passage which can contain pus and lead to further perianal abscesses and infection). Patients complete a questionnaire four, eight and 26 weeks after their operation to see whether they are experiencing any long-term pain in relation to their original surgery. Participants’ hospital records are accessed from the start of the study until six months after the study ends in order to capture information on any further wound-related input from healthcare services outside of the original hospital admission.

What are the possible benefits and risks of participating?
There are no confirmed disadvantages to not using internal dressings in the post-operative abscess cavity but the treatment has not been widely researched so it is an area of uncertainty. In some countries perianal abscesses are managed with no wound packing. It has been suggested that not packing the abscess cavity may reduce the drainage of pus from the wound and allow the skin to heal over the cavity. If this were the case it may increase the risk of future perianal abscess and the risk of fistula formation. However, there is no available data to confirm or refute this suggestion. Some patients can find changing the internal dressing painful and may find the regular visits with the practice/district nurse inconvenient. Those patients assigned to the non-packing arm may experience a reduction in dressing-related pain and more convenient treatment. Being a part of the study means all patients will have closer follow-up after their procedure than is normally provided.

Where is the study run from?
This study is being run by Liverpool Clinical Trials Unit (UK) and takes place in hospitals in the UK.

When is the study starting and how long is it expected to run for?
April 2017 to July 2020

Who is funding the study?
NIHR Central Commissioning Facility (CCF) (UK)

Who is the main contact?
Mrs Rachael Dagnall
jonesrm@liverpool.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Mrs Rachael Dagnall

ORCID ID

Contact details

PPAC2 Trial Coordinator
Liverpool Clinical Trials Unit
Block C
Waterhouse Building
1-3 Brownlow Street
Liverpool
L69 3GL
United Kingdom
+44 151 794 8383
jonesrm@liverpool.ac.uk

Additional identifiers

EudraCT number

Not applicable

ClinicalTrials.gov number

Protocol/serial number

35187

Study information

Scientific title

The impact of postoperative Packing of Perianal Abscess Cavities: a multicentre randomised controlled trial

Acronym

PPAC2: Packing of Perianal Abscess Cavities 2

Study hypothesis

The aim of this study is to determine if the use of simple dressings on the wound surface will result in reduced post-operative pain and improved quality of life with no increase in rate of recurrent abscess or fistula-in-ano following incision and drainage of perianal abscess when compared to traditional, internal packing.

Ethics approval

North West – Greater Manchester West Research Ethics Committee, 08/09/2017, ref: 17/NW/0529

Study design

Randomised; Both; Design type: Screening, Surgery, Health Economic

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Surgery, Primary sub-specialty: Other; UKCRC code/ Disease: Oral and Gastrointestinal/ Other diseases of intestines

Intervention

Patients presenting acutely with a primary perianal abscess who require surgical incision and drainage are randomised 1:1 post-operatively to either:

Arm A) Packing:
Participants in this group have their perianal abscess cavity internally packed as per normal practice.

Arm B) Non-packing:
Participants in this group have a pack placed in theatre as per normal practice, at dressing change the pack is removed and an external application of dressings applied to their perianal abscess cavity.

All patients complete a baseline health related quality of life (HRQOL) questionnaire, followed by daily pain diaries and HRQOL questionnaires until day 10, then again on days 14 and 21. Return to work is established via telephone interviews at seven, 14 and 21 days.

All participants undergo clinical assessment of healing, fistula-in-ano and abscess recurrence at four, eight (if not already healed at week four) and 26 weeks. Chronic pain is assessed at four, eight and 26 weeks. Clinical follow-up ceases at week 26. Hospital admissions for fistula-in-ano and perianal abscess recurrences str obtained from central, NHS registries from weeks 26 to 52.

Participants’ hospital records are accessed from the start of the study until six months after the study ends in order to capture information on any further wound-related input from healthcare services outside of the original hospital admission.

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measure

Wound-related pain (worst pain during previous 24 hours) is measured using patient reported 100mm Visual Analogue Score (VAS) where 0 represents “no pain” and 100 represents “worst pain possible” over the first 10 post-operative days.

Secondary outcome measures

1. Pain at dressing change is assessed using a 100mm VAS at days 1-10, day 14 and day 21
2. Health related quality of life are measured using the EQ-5D-5L descriptive system at baseline, days 1-5, and on day 7, 14 and 21
3. Health utility is measured using the EQ-5D-5L descriptive system at baseline, days 1-5, and on day 7, 14 and 21
4. Patient satisfaction with wound management is measured using a five point Likert Scale on day 10
5. Rate of wound healing (complete epithelialization) is measured via clinical examination at four and eight weeks
6. Post-operative fistula-in-ano measured via clinical examination at four, eight and 26 weeks and via hospital episode statistics between week 26 and week 52
7. Abscesses recurrence (after healing) is measured via clinical examination at four, eight and 26 weeks and via hospital episode statistics between week 26 and week 52
8. Bleeding requiring transfusion or return to theatre is measured via clinical examination until week 26
9. Chronic post-surgical pain is measured using the Brief Pain Inventory – short form at weeks 4, 8 and 26
10. Resource use (including dressing, health professional contact time, hospital admission, time to return to work or normal function, analgesic use) is measured up to week 52 via telephone interviews, pain diaries, hospital episodes statistics
11. Cost (applied to resource use data above)
12. Patient assessment of the method of pain control using the Patient Global Assessment of the method of pain control at days 1-10, day 14 and day 21

Overall trial start date

03/04/2017

Overall trial end date

30/07/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 years or over
2. Undergoing surgical incision and drainage of a primary perianal abscess

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 526; UK Sample Size: 526

Participant exclusion criteria

1. Suspected inflammatory bowel disease
2. Fournier’s Gangrene
3. Horseshoe (bilateral) abscess

Recruitment start date

30/11/2017

Recruitment end date

30/05/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Addenbrooke’s Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Trial participating centre

Blackpool Victoria Hospital
Whinney Heys Road
Blackpool
FY3 8NR
United Kingdom

Trial participating centre

Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Trial participating centre

Broomfield Hospital
Court Road Broomfield Essex
Chelmsford
CM1 7ET
United Kingdom

Trial participating centre

Countess of Chester Hospital
Liverpool Road
Chester
CH2 1UL
United Kingdom

Trial participating centre

Derriford Hospital
Derriford Road
Plymouth
PL6 8DH
United Kingdom

Trial participating centre

Furness General Hospital
Cumbria
LA14 4LF
United Kingdom

Trial participating centre

Glan Clwyd Hospital
Sarn Lane, Rhyl, Denbighshire
Bodelwyddan
LL18 5UJ
United Kingdom

Trial participating centre

Homerton Hospital
London
E9 6SR
United Kingdom

Trial participating centre

Macclesfield District General Hospital
Victoria Road
Macclesfield
SK10 3BL
United Kingdom

Trial participating centre

Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom

Trial participating centre

Norfolk and Norwich University Hospital
Colney Lane Norfolk
Norwich
NR4 7UY
United Kingdom

Trial participating centre

North Tyneside General Hospital
Rake Lane Tyne and Wear
North Shields
NE29 8NH
United Kingdom

Trial participating centre

Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom

Trial participating centre

Queen Elizabeth The Queen Mother Hospital
St Peters Road
Margate
CT9 4AN
United Kingdom

Trial participating centre

Royal Alexandra Hospital
Corsebar Road Renfrewshire
Paisley
PA9 2PN
United Kingdom

Trial participating centre

Royal Blackburn Hospital
Haslingden Road Lancashire
Blackburn
BB2 3HH
United Kingdom

Trial participating centre

Royal Bolton Hospital
Minerva Road
Farnworth
BL4 0JR
United Kingdom

Trial participating centre

Royal Devon and Exeter Hospital
Barrack Road Devon
Exeter
EX2 5DW
United Kingdom

Trial participating centre

Royal Free Hospital
Pond Street
Hampstead
NW3 2QG
United Kingdom

Trial participating centre

Royal Glamorgan Hospital
Llanistrant Rhonda Cynon Taff
Ynysmaerdy
CF72 8XR
United Kingdom

Trial participating centre

Royal Gwent Hospital
Cardiff Road
Newport
NP20 2UB
United Kingdom

Trial participating centre

Royal Lancaster Infirmary
Ashton Road Lancashire
Lancaster
LA1 4RP
United Kingdom

Trial participating centre

Royal Preston Hospital
Sharoe Green Lane
Preston
PR2 9HT
United Kingdom

Trial participating centre

Royal United Hospital
Hillview Lodge Coombe Park
Bath
BA1 3NG
United Kingdom

Trial participating centre

Northern General Hospital
Herries Road
Sheffield
S5 7AU
United Kingdom

Trial participating centre

Southmead Hospital
Southmead Road Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom

Trial participating centre

Trafford General Hospital
Moorside Road Davyhulme
Manchester
M41 5SL
United Kingdom

Trial participating centre

Queen Elizabeth Medical Centre
Edgbaston
Birmingham
B15 2TH
United Kingdom

Trial participating centre

Victoria Hospital
Hayfield Road
Kirkaldy
KY2 5AH
United Kingdom

Trial participating centre

Warwick Hospital
Lakin Road
Warwick
CV34 5BW
United Kingdom

Trial participating centre

Wrexham Maelor Hospital
Croesnewydd Road
Wrexham
LL13 7TD
United Kingdom

Trial participating centre

Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom

Trial participating centre

Yeovil District Hospital
Higher Kingston
Somerset
BA21 4AT
United Kingdom

Trial participating centre

Ysbyty Gwynedd (Bangor) Hospital
Penrhosgarnedd Gwynedd
Bangor
LL57 2PW
United Kingdom

Sponsor information

Organisation

Central Manchester University Hospitals NHS Foundation Trust

Sponsor details

Trust Headquarters
Cobbett House
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Central Commissioning Facility (CCF)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/07/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes