A Perianal Abscess Cavity Packing vs no Packing.

NCT04832529 | Completed DMC

• 1 other identifier: IRB-1537/DUHS/Approval/2020
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Perianal Abscess; Ischiorectal Abscess

Outcome Measures

Primary Outcomes (1)

• Post-operative pain

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

  14 days

Secondary Outcomes (1)

• Decreases hospital visit

  3 weeks

Study Arms (2)

Perianal abscess cavity packing

ACTIVE COMPARATOR

Procedure: No packing of perianal abscess cavity

Perianal abscess cavity no packing

EXPERIMENTAL

Procedure: No packing of perianal abscess cavity

Interventions

No packing of perianal abscess cavity PROCEDURE

introducing new method to no packing of abscess cavity.

Perianal abscess cavity no packing; Perianal abscess cavity packing

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dr Ruth K.M Pfau Civil Hospital

Karachi, Sindh, 75000, Pakistan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Experimental Randomized Control Trial

Study Record Dates

• First Submitted: March 21, 2021
• First Posted: April 5, 2021
• Study Start: March 1, 2020
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: August 26, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)