Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-04-26 @ 7:03 AM
Study NCT ID:
NCT03315169
Status:
COMPLETED
Last Update Posted:
2020-09-09
First Post:
2017-10-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Packing of Perianal Abscess Cavities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000038', 'term': 'Abscess'}, {'id': 'D000072836', 'term': 'Surgical Wound'}], 'ancestors': [{'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Note that only the clinician assessing healing and fistulae are masked.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 433}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-08', 'studyFirstSubmitDate': '2017-10-11', 'studyFirstSubmitQcDate': '2017-10-16', 'lastUpdatePostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wound-related pain intensity', 'timeFrame': 'Mean score over first 10 post-operative days', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Dressing-change related pain intensity', 'timeFrame': 'First 10 post-operative days', 'description': "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."}, {'measure': 'Health related quality of life', 'timeFrame': 'On the 21st post-operative day', 'description': "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."}, {'measure': 'Health utility', 'timeFrame': 'On the 21st post-operative day', 'description': "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."}, {'measure': 'Patient satisfaction with wound management', 'timeFrame': 'On the 21st post-operative day', 'description': "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'."}, {'measure': 'Rate of wound healing', 'timeFrame': 'Four and eight weeks post-operatively', 'description': 'Rate of wound healing (complete epithelialization)'}, {'measure': 'Clinical diagnosis of perianal abscesses recurrence after healing', 'timeFrame': '52 weeks post-operatively', 'description': '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.'}, {'measure': 'Chronic post-surgical pain', 'timeFrame': '4, 8 and 26 weeks post-operatively', 'description': '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".'}, {'measure': 'Dressing use', 'timeFrame': 'Up to 52 weeks post-operatively', 'description': 'Number of dressings used between time of operation up until week 52.'}, {'measure': 'Health Professional contact time', 'timeFrame': 'Up to 52 weeks post-operatively', 'description': 'Number of contacts with a Health Professional regarding perianal abscess or post-surgical complications between time of operation and 52 weeks post-operatively.'}, {'measure': 'Hospital admission time', 'timeFrame': 'Up to 52 weeks post-operatively', 'description': 'Number and length of hospital admissions as recorded in NHS central registries - Hospital Episodes Statistics.'}, {'measure': 'Time to return to work or normal function', 'timeFrame': 'Up to 52 weeks post-operatively', 'description': 'Length of time, measured in days, between operation and return to work or normal function.'}, {'measure': 'Cost', 'timeFrame': 'Up to 52 weeks post-operatively', 'description': 'Cost as applied to resource use data (see outcome 9-12)'}, {'measure': 'Assessment of pain control methods', 'timeFrame': '21 days post-operatively', 'description': '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".'}, {'measure': 'Fistula rate', 'timeFrame': 'Up ro 52 weeks post-operatively', 'description': 'Fistula rate observed during clinical follow up and through Hospital Episodes Statistics'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Incision and Drainage', 'Packing'], 'conditions': ['Perianal Abscess', 'Perianal Infections', 'Peri Rectal Abscess', 'Abscess; Anus', 'Abscess Anorectal']}, 'referencesModule': {'references': [{'pmid': '27562822', 'type': 'BACKGROUND', 'citation': 'Smith SR, Newton K, Smith JA, Dumville JC, Iheozor-Ejiofor Z, Pearce LE, Barrow PJ, Hancock L, Hill J. Internal dressings for healing perianal abscess cavities. Cochrane Database Syst Rev. 2016 Aug 26;2016(8):CD011193. doi: 10.1002/14651858.CD011193.pub2.'}, {'pmid': '27061287', 'type': 'BACKGROUND', 'citation': 'Pearce L, Newton K, Smith SR, Barrow P, Smith J, Hancock L, Kirwan CC, Hill J; North West Research Collaborative. Multicentre observational study of outcomes after drainage of acute perianal abscess. Br J Surg. 2016 Jul;103(8):1063-8. doi: 10.1002/bjs.10154. Epub 2016 Apr 7.'}, {'pmid': '35929816', 'type': 'DERIVED', 'citation': 'Newton K, Dumville J, Briggs M, Law J, Martin J, Pearce L, Kirwan C, Pinkney T, Needham A, Jackson R, Winn S, McCulloch H, Hill J; PPAC2 Collaborators. Postoperative Packing of Perianal Abscess Cavities (PPAC2): randomized clinical trial. Br J Surg. 2022 Sep 9;109(10):951-957. doi: 10.1093/bjs/znac225.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nA 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%.\n\nThis 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.\n\nAll 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Aged 18 or over\n2. Undergoing surgical incision and drainage of a primary perianal abscess\n\nExclusion Criteria:\n\n1. Suspected inflammatory bowel disease\n2. Fournier's Gangrene\n3. Horseshoe (bilateral) abscess\n4. Fistula-in-ano\n5. Multiple abscess"}, 'identificationModule': {'nctId': 'NCT03315169', 'acronym': 'PPAC2', 'briefTitle': 'Packing of Perianal Abscess Cavities', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Manchester University NHS Foundation Trust'}, 'officialTitle': 'The Impact of Postoperative Packing of Perianal Abscess Cavities: a Multicentre Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'R04689'}, 'secondaryIdInfos': [{'id': 'PB-PG-0815-20037', 'type': 'OTHER_GRANT', 'domain': 'NIHR RfPB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Packing of perianal abscess cavity', 'description': 'Internal packing of perianal abscess cavity as per normal practice.', 'interventionNames': ['Other: Packing of perianal abscess cavity']}, {'type': 'EXPERIMENTAL', 'label': 'External dressing', 'description': 'External application of a non-adherent dressing to the perianal abscess cavity.', 'interventionNames': ['Other: External dressing']}], 'interventions': [{'name': 'External dressing', 'type': 'OTHER', 'description': 'Application of external dressing whilst perianal abscess cavity heals.', 'armGroupLabels': ['External dressing']}, {'name': 'Packing of perianal abscess cavity', 'type': 'OTHER', 'description': 'Internal packing of perianal abscess cavity - standard treatment.', 'armGroupLabels': ['Packing of perianal abscess cavity']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M6 8HD', 'city': 'Salford', 'state': 'Greater Manchester', 'country': 'United Kingdom', 'facility': 'Salford Royal Hospital', 'geoPoint': {'lat': 53.48771, 'lon': -2.29042}}, {'zip': 'TW7 6AF', 'city': 'Isleworth', 'state': 'Middlesex', 'country': 'United Kingdom', 'facility': 'West Middlesex University Hospital (Isleworth)', 'geoPoint': {'lat': 51.47518, 'lon': -0.34246}}, {'zip': 'OX3 9DZ', 'city': 'Oxford', 'state': 'Oxfordshire', 'country': 'United Kingdom', 'facility': 'John Radcliffe Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'WV10 0QP', 'city': 'Wolverhampton', 'state': 'West Midlands', 'country': 'United Kingdom', 'facility': 'Mew Cross Hospital', 'geoPoint': {'lat': 52.58547, 'lon': -2.12296}}, {'zip': 'HD3 3EA', 'city': 'Huddersfield', 'state': 'West Yorkshire', 'country': 'United Kingdom', 'facility': 'Huddersfield Royal Infirmary', 'geoPoint': {'lat': 53.64904, 'lon': -1.78416}}, {'zip': 'WF1 4DS', 'city': 'Wakefield', 'state': 'West Yorkshire', 'country': 'United Kingdom', 'facility': 'Pindersfields General Hospital', 'geoPoint': {'lat': 53.68331, 'lon': -1.49768}}, {'zip': 'SP2 8BJ', 'city': 'Salisbury', 'state': 'Wiltshire', 'country': 'United Kingdom', 'facility': 'Salisbury District Hospital', 'geoPoint': {'lat': 51.06931, 'lon': -1.79569}}, {'city': 'Aberdeen', 'country': 'United Kingdom', 'facility': 'Aberdeen Royal Infirmary', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}, {'city': 'Bangor', 'country': 'United Kingdom', 'facility': 'Bangor Hospital, Betsi Cadwaladr University Health 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'Royal Bolton Hospital', 'geoPoint': {'lat': 53.58333, 'lon': -2.43333}}, {'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Bristol royal Infirmary, University Hospitals Bristol', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Southmead Hospital North Bristo; NHS Trust', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'city': 'Cambridge', 'country': 'United Kingdom', 'facility': "Addenbrooke's Hospital", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'University Hospital of Wales (Cardiff)', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'city': 'Chelmsford', 'country': 'United Kingdom', 'facility': 'Broomfield Hospital', 'geoPoint': {'lat': 51.73575, 'lon': 0.46958}}, {'zip': 'CH2 1UL', 'city': 'Chester', 'country': 'United Kingdom', 'facility': 'Countess of Chester', 'geoPoint': {'lat': 53.1905, 'lon': -2.89189}}, {'city': 'Chesterfield', 'country': 'United Kingdom', 'facility': 'Chesterfield Royal Hospital NHS Foundation Trust', 'geoPoint': {'lat': 53.25, 'lon': -1.41667}}, {'city': 'Coventry', 'country': 'United Kingdom', 'facility': 'University Hospitals Coventry and Warwickshire', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'city': 'Exeter', 'country': 'United Kingdom', 'facility': 'Royal Devon & Exeter Hospital', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}, {'city': 'Kirkcaldy', 'country': 'United Kingdom', 'facility': 'Victoria Hospital (Fife)', 'geoPoint': {'lat': 56.11683, 'lon': -3.15999}}, {'city': 'Lancaster', 'country': 'United Kingdom', 'facility': 'Royal Lancaster Infirmary', 'geoPoint': {'lat': 54.04649, 'lon': -2.79988}}, {'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Aintree Hospital', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Royal Liverpool and Broadgreen University Hospitals NHS Trust', 'geoPoint': {'lat': 53.41058, 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Gwent Hospital', 'geoPoint': {'lat': 51.58774, 'lon': -2.99835}}, {'city': 'Norwich', 'country': 'United Kingdom', 'facility': 'Norfolk and Norwich University Hospital', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}, {'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nottingham University Hospitals NHS Trust', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'city': 'Paisley', 'country': 'United Kingdom', 'facility': 'Royal Alexandra Hospital', 'geoPoint': {'lat': 55.83173, 'lon': -4.43254}}, {'city': 'Plymouth', 'country': 'United Kingdom', 'facility': 'Plymouth Hospitals NHS Trust Derriford Hospital', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'city': 'Portsmouth', 'country': 'United Kingdom', 'facility': 'Portsmouth Hospitals NHS Trust', 'geoPoint': {'lat': 50.79899, 'lon': -1.09125}}, {'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Sheffield Teaching Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'Southampton General Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'city': 'Upton', 'country': 'United Kingdom', 'facility': 'Arrowe Park Hospital', 'geoPoint': {'lat': 53.61466, 'lon': -1.28677}}, {'city': 'Warrington', 'country': 'United Kingdom', 'facility': 'Warrington Hospital', 'geoPoint': {'lat': 53.39254, 'lon': -2.58024}}, {'city': 'Warwick', 'country': 'United Kingdom', 'facility': 'Warwick Hospital, South Warwickshire NHS Foundation Trust', 'geoPoint': {'lat': 52.28333, 'lon': -1.58333}}, {'city': 'West Bromwich', 'country': 'United Kingdom', 'facility': 'Sandwell Hospital, SWBH NHS Trust', 'geoPoint': {'lat': 52.51868, 'lon': -1.9945}}, {'city': 'Wigan', 'country': 'United Kingdom', 'facility': 'Royal Albert and Edward Infirmary', 'geoPoint': {'lat': 53.54296, 'lon': -2.63706}}, {'city': 'Wrexham', 'country': 'United Kingdom', 'facility': 'Wrexham Maelor Hospital, Betsi Cadwaladr University Health Board', 'geoPoint': {'lat': 53.04664, 'lon': -2.99132}}, {'city': 'Yeovil', 'country': 'United Kingdom', 'facility': 'Yeovil District Hospital', 'geoPoint': {'lat': 50.94159, 'lon': -2.63211}}], 'overallOfficials': [{'name': 'James Hill, FRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Manchester University NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Manchester University NHS Foundation Trust', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University of Liverpool', 'class': 'OTHER'}, {'name': 'Northwest Research Collaborative', 'class': 'UNKNOWN'}, {'name': 'University of Birmingham', 'class': 'OTHER'}, {'name': 'National Institute for Health Research, United Kingdom', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}