A Perianal Abscess Cavity Packing vs no Packing.

NCT ID: NCT04832529

Last Updated: 2022-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-07-31

Brief Summary

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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

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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.

Conditions

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Perianal Abscess Ischiorectal Abscess

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Experimental Randomized Control Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Perianal abscess cavity packing

Group Type ACTIVE_COMPARATOR

No packing of perianal abscess cavity

Intervention Type PROCEDURE

introducing new method to no packing of abscess cavity.

Perianal abscess cavity no packing

Group Type EXPERIMENTAL

No packing of perianal abscess cavity

Intervention Type PROCEDURE

introducing new method to no packing of abscess cavity.

Interventions

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No packing of perianal abscess cavity

introducing new method to no packing of abscess cavity.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dow University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Lajpat Rai

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dr Ruth K.M Pfau Civil Hospital

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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IRB-1537/DUHS/Approval/2020

Identifier Type: -

Identifier Source: org_study_id

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