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A Perianal Abscess Cavity Packing vs no Packing.

Primary Purpose

Perianal Abscess, Ischiorectal Abscess

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
No packing of perianal abscess cavity
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perianal Abscess

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age greater than 18 years
  • Age less than 70 years
  • Perianal abscess

Exclusion Criteria:

  • Suspected inflammatory bowel disease
  • Fournier's gangrene
  • Horseshoe/bilateral abscess

Sites / Locations

  • Dr Ruth K.M Pfau Civil Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Perianal abscess cavity packing

Perianal abscess cavity no packing

Arm Description

Outcomes

Primary Outcome Measures

Post-operative pain
Pain will be assessed via visual analogue scale from 1-10 while changing of dressing.

Secondary Outcome Measures

Decreases hospital visit
Hospital visits will be decreased when dressing only dressing to be done, not wound packing.

Full Information

First Posted
March 21, 2021
Last Updated
August 24, 2022
Sponsor
Dow University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04832529
Brief Title
A Perianal Abscess Cavity Packing vs no Packing.
Official Title
A Perianal Abscess Cavity Packing Versus no Packing; a Randomized Control Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This prospective randomized trial will be conducted in all patients undergoing packing or no packing for perianal abscess cavity after incision and drainage, for 6 months after approval from IRB in Surgical unit III, Civil Hospital Karachi. Patient will be selected simple random sampling technique based on inclusion criteria. Patient will be assessed for post-operative pain, healing of cavity and recurrence of abscess. At first time of debridement pus or tissue will be sent for culture and sensitivity, meanwhile broad-spectrum antibiotic will be started. Questionnaire will be filled by PI for post-operative pain, recurrence of abscess, quality of life, wound healing, post operative fistula in ano and chronic post surgical pain either due to packing or no packing.
Detailed Description
This is an experimental randomized control trial will start 6 months after approval from Institution Review Board. All patients with perianal abscess after incision and drainage cavity will be either packed or not after informed consent. Pack will be changed daily as regular dressing till healing occurs. Packing reduces bleeding and heals cavity by effect of dressing solution in which gauze is soaked. Other group with dressing will be changed daily and will be assessed for healing week. There is no pain in simple dressing applied over cavity. Patient will receive broad spectrum antibiotics according to pus or tissue culture. During this period, laboratory investigation CBC, CRP will be sent to check the response. Sits bath will be advised to both groups. Post-operative pain, cavity healing will be assessed by faculty.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perianal Abscess, Ischiorectal Abscess

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental Randomized Control Trial
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Perianal abscess cavity packing
Arm Type
Active Comparator
Arm Title
Perianal abscess cavity no packing
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
No packing of perianal abscess cavity
Intervention Description
introducing new method to no packing of abscess cavity.
Primary Outcome Measure Information:
Title
Post-operative pain
Description
Pain will be assessed via visual analogue scale from 1-10 while changing of dressing.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Decreases hospital visit
Description
Hospital visits will be decreased when dressing only dressing to be done, not wound packing.
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age greater than 18 years Age less than 70 years Perianal abscess Exclusion Criteria: Suspected inflammatory bowel disease Fournier's gangrene Horseshoe/bilateral abscess
Facility Information:
Facility Name
Dr Ruth K.M Pfau Civil Hospital
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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A Perianal Abscess Cavity Packing vs no Packing.

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