NCT01739478

Brief Summary

The aim of this study is to compare the effect of packing and non-packing on the healing rate of perianal abscess cavities. Secondary objectives are to assess quality of life, cost effectiveness and rate of abscess recurrence and fistula-in-ano formation. If there is no difference in time to healing and non-packing is shown to be safe, acceptable to the patient and cost effective, this approach may become more widely accepted.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

November 29, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 3, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 4, 2012

Status Verified

December 1, 2012

First QC Date

November 29, 2012

Last Update Submit

December 2, 2012

Conditions

Perianal Abscess

Outcome Measures

Primary Outcomes (1)

  • Time to wound healing in days, defined as complete epithelialisation of the abscess cavity.

    time to healing will be assessed in days

    1 day to 6 weeks

Secondary Outcomes (1)

  • Quality of life scores as determined by the Euro QoL EQ-5D-3L

    10 to 14 days

Other Outcomes (3)

  • Abscess recurrence rate

    0 days to 12 months

  • Fistula-in-ano formation rate

    0 days to 18 months

  • Cost

    0 days to 18 months

Study Arms (2)

Non-packing of abscess cavity

EXPERIMENTAL
Other: External dressing

Packing of abscess cavity

OTHER

Current practice

Other: Packing of abscess cavityOther: External dressing

Interventions

Packing of abscess cavityOTHER
Packing of abscess cavity
External dressingOTHER

Application of external dressing whilst abscess cavity heals

Non-packing of abscess cavityPacking of abscess cavity

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of acute primary perianal abscess
  • Have undergone surgical incision and drainage as an emergency

You may not qualify if:

  • The abscess is the sequelae of concurrent disease or trauma
  • Fourniers gangrene is suspected
  • Unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2012

First Posted

December 3, 2012

Primary Completion

January 1, 2015

Study Completion

December 1, 2015

Last Updated

December 4, 2012

Record last verified: 2012-12