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Completed

NCT Number: NCT03315169

Packing of Perianal Abscess Cavities

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Salford Royal Hospital, Salford, Greater Manchester, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

External dressing

Other

Application of external dressing whilst perianal abscess cavity heals.

Packing of perianal abscess cavity

Other

Internal packing of perianal abscess cavity - standard treatment.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Dressing-change related pain intensity

    Time frame: First 10 post-operative days

    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.

  2. Health related quality of life

    Time frame: On the 21st post-operative day

    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.

  3. Health utility

    Time frame: On the 21st post-operative day

    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.

  4. Patient satisfaction with wound management

    Time frame: On the 21st post-operative day

    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'.

  5. Rate of wound healing

    Time frame: Four and eight weeks post-operatively

    Rate of wound healing (complete epithelialization)

  6. Clinical diagnosis of perianal abscesses recurrence after healing

    Time frame: 52 weeks post-operatively

    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.

  7. Chronic post-surgical pain

    Time frame: 4, 8 and 26 weeks post-operatively

    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".

  8. Dressing use

    Time frame: Up to 52 weeks post-operatively

    Number of dressings used between time of operation up until week 52.

  9. Health Professional contact time

    Time frame: Up to 52 weeks post-operatively

    Number of contacts with a Health Professional regarding perianal abscess or post-surgical complications between time of operation and 52 weeks post-operatively.

  10. Hospital admission time

    Time frame: Up to 52 weeks post-operatively

    Number and length of hospital admissions as recorded in NHS central registries - Hospital Episodes Statistics.

  11. Time to return to work or normal function

    Time frame: Up to 52 weeks post-operatively

    Length of time, measured in days, between operation and return to work or normal function.

  12. Cost

    Time frame: Up to 52 weeks post-operatively

    Cost as applied to resource use data (see outcome 9-12)

  13. Assessment of pain control methods

    Time frame: 21 days post-operatively

    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".

  14. Fistula rate

    Time frame: Up ro 52 weeks post-operatively

    Fistula rate observed during clinical follow up and through Hospital Episodes Statistics

Sponsors and collaborators

Lead sponsor

Manchester University NHS Foundation Trust

Other Gov

Collaborators

  • National Institute for Health Research, United Kingdom
  • Northwest Research Collaborative
  • University of Birmingham
  • University of Liverpool

Registry information

Official study title

The Impact of Postoperative Packing of Perianal Abscess Cavities: a Multicentre Randomised Controlled Trial

Acronym: PPAC2

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 20, 2017
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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