Postoperative Packing of Perianal Abscess Cavities (PPAC2): randomized clinical trial
Author:
Newton Katy1, Dumville Jo2, Briggs Michelle2, Law Jennifer3ORCID, Martin Julia3, Pearce Lyndsay4, Kirwan Cliona5, Pinkney Thomas6, Needham Alexander7, Jackson Richard7, Winn Simon7, McCulloch Haley7, Hill James1, Watson A, Johnson M, Hiller L, Psarelli E, Murray L, Smith A, Brown S, Singh B, Newby C, Ali O, Sukha A, Blencowe N, Narang S, Reeves N, Faulkner G, Rajamanickam S, Evans J, Mangam S, Harilingham M, Smart C J, Ward S J, Bogdan M, Amin K, Al-Khaddar Z, Davies E, Patel P, Stearns A, Shaik I, Hernon J, Pal A, Lewis M, Barker J, Gerrard A, Abdel-Halim M, Shuttleworth P, Lee M J, Peckham-Cooper A B P, Hague A G, Challand C, Steele C, Fearnhead N, Van Laarhoven S, Brady R, Shaban F, Wong N, Ngu W, Williams G, Codd R, Magowan D, Leong K, Williams G, Torrance A, Bharathan B, Pawa N, Sekhon H Kaur, Singh I, Alabi A, Berry D, Trompetas V, Hughes J L, Lunevicius R, Lunevicius R, Mann K, Dixon S, Ingram T, Gilbert T, Brooks C, Madzamba G, Pullyblank A, Dovell G, Newton L, Carter N, May-Miller P, Shaikh S, Shearer R, Macleod C, Parnaby C, Abdelmabod A, Titu L, Majeed T, Hargest R, Parker J, Zabkiewicz C, Reeves N, Soliman F, Gossedge G, Selvachandran H, Dilworth M, Vimalachandran D, Singh H, Koh H, Randall J, Moug S, Adeosun A, Dennison G, Curtis N, Smart N, Duff S, Rahman M, Wu F,
Affiliation:
1. Department of General Surgery, Manchester Royal Infirmary, Manchester University NHS Foundation Trust , UK 2. School of Midwifery, Nursing and Social Work, University of Manchester , UK 3. North West Research Collaborative , UK 4. Department of General Surgery, Salford Royal NHS Foundation Trust , UK 5. Department of Academic Surgery, Wythenshawe Hospital, Manchester University NHS Foundation Trust , UK 6. Academic Department of Surgery, University of Birmingham , UK 7. Liverpool Clinical Trials Unit , UK
Abstract
Abstract
Background
Perianal abscess is common. Traditionally, postoperative perianal abscess cavities are managed with internal wound packing, a practice not supported by evidence. The aim of this randomized clinical trial (RCT) was to assess if non-packing is less painful and if it is associated with adverse outcomes.
Methods
The Postoperative Packing of Perianal Abscess Cavities (PPAC2) trial was a multicentre, RCT (two-group parallel design) of adult participants admitted to an NHS hospital for incision and drainage of a primary perianal abscess. Participants were randomized 1:1 (via an online system) to receive continued postoperative wound packing or non-packing. Blinded data were collected via symptom diaries, telephone, and clinics over 6 months. The objective was to determine whether non-packing of perianal abscess cavities is less painful than packing, without an increase in perianal fistula or abscess recurrence. The primary outcome was pain (mean maximum pain score on a 100-point visual analogue scale).
Results
Between February 2018 and March 2020, 433 participants (mean age 42 years) were randomized across 50 sites. Two hundred and thirteen participants allocated to packing reported higher pain scores than 220 allocated to non-packing (38.2 versus 28.2, mean difference 9.9; P < 0.0001). The occurrence of fistula-in-ano was low in both groups: 32/213 (15 per cent) in the packing group and 24/220 (11 per cent) in the non-packing group (OR 0.69, 95 per cent c.i. 0.39 to 1.22; P = 0.20). The proportion of patients with abscess recurrence was also low: 13/223 (6 per cent) in the non-packing group and 7/213 (3 per cent) in the packing group (OR 1.85, 95 per cent c.i. 0.72 to 4.73; P = 0.20).
Conclusion
Avoiding abscess cavity packing is less painful without a negative morbidity risk.
Registration number
ISRCTN93273484 (https://www.isrctn.com/ISRCTN93273484).
Registration number
NCT03315169 (http://clinicaltrials.gov)
Funder
National Institute for Health Research
Publisher
Oxford University Press (OUP)
Cited by
14 articles.
订阅此论文施引文献
订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献
|
|