A Perianal Abscess Cavity Packing vs no Packing.

Not Applicable

Completed

• Conditions: Ischiorectal Abscess; Perianal Abscess
• Interventions: Procedure: No packing of perianal abscess cavity

• Registration Number: NCT04832529
• Lead Sponsor: Dow University of Health Sciences

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.

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2021-03-21
• Study First Submitted QC: 2021-04-02
• Study First Posted: 2021-04-05
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Perianal abscess cavity packing	No packing of perianal abscess cavity	-
Perianal abscess cavity no packing	No packing of perianal abscess cavity	-

Primary Outcome Measures

Name	Time	Method
Post-operative pain	14 days	Pain will be assessed via visual analogue scale from 1-10 while changing of dressing.

Secondary Outcome Measures

Name	Time	Method
Decreases hospital visit	3 weeks	Hospital visits will be decreased when dressing only dressing to be done, not wound packing.

Trial Locations

Locations (1)

Dr Ruth K.M Pfau Civil Hospital; 🇵🇰 Karachi, Sindh, Pakistan