An interventional study of External dressing and Packing of perianal abscess cavity in Perianal Abscess, Perianal Infections and Peri Rectal Abscess, sponsored by Manchester University NHS Foundation Trust. Completed at 50 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-09.
Sponsored by Manchester University NHS Foundation Trust · Not applicable, Interventional, and Treatment
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.
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.
152 studies on the registry are indexed under Abscess; 22 are open to participants now.
This study's enrollment of 433 is above the median of 110 across 120 interventional studies indexed under Abscess.
Browse Abscess studies →Manchester University NHS Foundation Trust is the lead sponsor of 140 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
Internal packing of perianal abscess cavity as per normal practice.
Other: Packing of perianal abscess cavity
External application of a non-adherent dressing to the perianal abscess cavity.
Other: External dressing
Application of external dressing whilst perianal abscess cavity heals.
Internal packing of perianal abscess cavity - standard treatment.
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.
Time frame: Mean score over first 10 post-operative days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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'.
Time frame: On the 21st post-operative day
Rate of wound healing
Rate of wound healing (complete epithelialization)
Time frame: 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.
Time frame: 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".
Time frame: 4, 8 and 26 weeks post-operatively
Dressing use
Number of dressings used between time of operation up until week 52.
Time frame: 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.
Time frame: Up to 52 weeks post-operatively
Hospital admission time
Number and length of hospital admissions as recorded in NHS central registries - Hospital Episodes Statistics.
Time frame: 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.
Time frame: Up to 52 weeks post-operatively
Cost
Cost as applied to resource use data (see outcome 9-12)
Time frame: 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".
Time frame: 21 days post-operatively
Fistula rate
Fistula rate observed during clinical follow up and through Hospital Episodes Statistics
Time frame: Up ro 52 weeks post-operatively
Plan to share: No
Ran from Feb 2018 to primary completion in Jun 2020, 27 months.
Of 21 interventional studies with no phase under Abscess, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 56. This study's 27 months is below that.
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This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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