Packing of Perianal Abscess Cavities

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Perianal Abscess, Perianal Infections, Peri Rectal Abscess, Abscess; Anus, Abscess Anorectal

Intervention / Treatment
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* Other: External dressing
* Other: Packing of perianal abscess cavity


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Packing of perianal abscess cavity<br>Internal packing of perianal abscess cavity as per normal practice. | Other: Packing of perianal abscess cavity<br>* Internal packing of perianal abscess cavity - standard treatment.<br>|
| Experimental: External dressing<br>External application of a non-adherent dressing to the perianal abscess cavity. | Other: External dressing<br>* Application of external dressing whilst perianal abscess cavity heals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Mean score over first 10 post-operative days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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'. | On the 21st post-operative day | 
| Rate of wound healing | Rate of wound healing (complete epithelialization) | 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. | 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. | 4, 8 and 26 weeks post-operatively | 
| Dressing use | Number of dressings used between time of operation up until week 52. | 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. | Up to 52 weeks post-operatively | 
| Hospital admission time | Number and length of hospital admissions as recorded in NHS central registries - Hospital Episodes Statistics. | 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. | Up to 52 weeks post-operatively | 
| Cost | Cost as applied to resource use data (see outcome 9-12) | 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. | 21 days post-operatively | 
| Fistula rate | Fistula rate observed during clinical follow up and through Hospital Episodes Statistics | Up ro 52 weeks post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Incision and Drainage, Packing