NCT01853267

Brief Summary

TITLE Perianal Abscess Packing (PAP): a randomised controlled trial (Pilot study) DESIGN Randomised controlled trial. HYPOTHESIS In patients with perianal abscesses incision and drainage without packing the subsequent cavity will reduce patient discomfort without increasing healing time or recurrence compared with management involving cavity packing. OUTCOME MEASURES

  • Length of hospital stay
  • Time to cavity healing
  • Recurrent abscess or fistula formation
  • Pain score
  • Analgesia usage POPULATION All patients older than 18 years presenting with a perianal abscess. ELIGIBILITY Exclusion criteria:
  • under 18 years
  • those unable to give informed consent
  • abscesses associated with Crohn's disease or other underlying causes
  • abscesses in which initial drainage is considered inadequate (if the skin is not open sufficiently to allow drainage of the abscess cavity) DURATION Until recruitment of subjects is complete

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2013

Completed
Last Updated

May 21, 2014

Status Verified

May 1, 2013

Enrollment Period

1.6 years

First QC Date

May 10, 2013

Last Update Submit

May 20, 2014

Conditions

Perianal Abscess

Keywords

ColorectalSurgeryPerianalAbscess

Outcome Measures

Primary Outcomes (1)

  • Time to abscess healing

    When abscess cavity has re-epitheliased. Assessed at two weeks and then weekly until healing occurs. Followed up for one year to assess recurrence

    Two weeks post operative

Study Arms (2)

Control group (Packing)

ACTIVE COMPARATOR

The perianal abscess cavity will continue to be packed after discharge until healing is complete

Procedure: Control group (Packing)

Intervention Group (Non-Packing)

EXPERIMENTAL

The cavity will be allowed to heal by secondary intention without packing.

Procedure: Intervention Group (Non-Packing)

Interventions

Intervention Group (Non-Packing)PROCEDURE

The haemostatic pack placed in the perianal abscess cavity will be removed on discharge and the wound will be left to heal without packing in situ

Intervention Group (Non-Packing)
Control group (Packing)PROCEDURE

After the procedure the abscess cavity will be packed with a non-adherent dressing as per standard treatment and the packing changed at regular intervals in the community until healing by secondary intention is complete.

Control group (Packing)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18
  • Clinical diagnosis of perianal abscess.

You may not qualify if:

  • Patients who are unable or unwilling to consent.
  • Known fistulae
  • Crohn's Disease
  • Immune-suppression or malignancy
  • Recurrent abscess (where initial drainage insufficient).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Mary's Hospital

Paddington, London, W2 1NY, United Kingdom

Location

Related Publications (1)

  • Perera AP, Howell AM, Sodergren MH, Farne H, Darzi A, Purkayastha S, Paraskeva P. A pilot randomised controlled trial evaluating postoperative packing of the perianal abscess. Langenbecks Arch Surg. 2015 Feb;400(2):267-71. doi: 10.1007/s00423-014-1231-5. Epub 2014 Jul 23.

    PMID: 25053508DERIVED

MeSH Terms

Conditions

Abscess

Interventions

Control GroupsDrug Packaging

Condition Hierarchy (Ancestors)

SuppurationInfectionsInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethodsTechnology, PharmaceuticalDrug IndustryManufacturing IndustryIndustryTechnology, Industry, and AgricultureProduct Packaging

Study Officials

  • Paraskevas Paraskevas, MBBS

    Department of Surgery and Cancer, Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2013

First Posted

May 14, 2013

Study Start

May 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

May 21, 2014

Record last verified: 2013-05

Locations

GB(1)