Postoperative treatment of perianal abscess cavities: comparing the use of internal wound packing to external dressings

Plain English Summary

Current plain English summary as of 19/07/2019:
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 February 2020 (updated 11/06/2019, previously: July 2020)

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

Who is the main contact?
Simon Winn
simon.winn@liverpool.ac.uk
0151 795 7795

Godwin Dennison (Principal Investigator who replaced the previous Principal Investigator, Mr Nathan Curtis)
godwin.dennison@ydh.nhs.uk
01935384653


Previous 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 February 2020 (updated 11/06/2019, previously: 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

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• Scotland
• United Kingdom
• Wales

Study participating centres

Sponsor information

Central Manchester University Hospitals NHS Foundation Trust
Hospital/treatment centre

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

"ROR"	https://ror.org/00he80998

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

08/08/2022: Publication reference and total final enrolment added.
18/08/2021: The intention to publish date has been changed from 14/02/2021 to 30/10/2021.
19/07/2019: The plain English summary was updated.
16/07/2019: The following changes were made to the trial record:
1. The participant exclusion criteria were updated
2. The scientific contact was added.
11/06/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/05/2019 to 30/09/2019.
2. The overall end date was changed from 30/07/2020 to 14/02/2020.
3. The intention to publish date was changed from 31/07/2021 to 14/02/2021.
4. The plain English summary was updated to reflect these changes.
03/04/2019: The condition has been changed from "Specialty: Surgery, Primary sub-specialty: Other; UKCRC code/ Disease: Oral and Gastrointestinal/ Other diseases of intestines" to "Surgery" following a request from the NIHR.
01/02/2019: New Cross Hospital, Morriston Hospital and John Radcliffe Hospital were added as trial participating centres.
11/12/2018: The public contact details were updated.