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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN93273484

Enrollment

526

Registered

2017-11-01

Start date

2017-11-30

Completion date

Unknown

Last updated

2022-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery Digestive System Oral and Gastrointestinal

Interventions

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: P

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Current participant exclusion criteria as of 16/07/2019: 1. Suspected inflammatory bowel disease. 2. Fournier’s Gangrene. 3. Horseshoe (bilateral) abscess. 4. Fistula-in-ano. 5. Multiple abscesses. Previous participant exclusion criteria: 1. Suspected inflammatory bowel disease 2. Fournier’s Gangrene 3. Horseshoe (bilateral) abscess

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

England, Scotland, United Kingdom, Wales

Contacts

Public ContactSimon Winn

simon.winn@liverpool.ac.uk+44 151 794 5294

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 11, 2026