A Perianal Abscess Cavity Packing vs no Packing.

Perianal Abscess Clinical Trial

Official title:

A Perianal Abscess Cavity Packing Versus no Packing; a Randomized Control Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04832529
• Other study ID #: IRB-1537/DUHS/Approval/2020
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: August 2022
• Source: Dow University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Abscess
• Ischiorectal Abscess
• Perianal Abscess

Intervention

Procedure:
• No packing of perianal abscess cavity
introducing new method to no packing of abscess cavity.

Locations

Country	Name	City	State
Pakistan	Dr Ruth K.M Pfau Civil Hospital	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain	Pain will be assessed via visual analogue scale from 1-10 while changing of dressing.	14 days
Secondary	Decreases hospital visit	Hospital visits will be decreased when dressing only dressing to be done, not wound packing.	3 weeks