A Perianal Abscess Cavity Packing vs no Packing.

• Sponsor: Dow University of Health Sciences (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04832529
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 16
• Patients Per Site Per Month: 4.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Perianal Abscess; Ischiorectal Abscess	Procedure: No packing of perianal abscess cavity	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Experimental Randomized Control TrialExperimental Randomized Control Trial
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: A Perianal Abscess Cavity Packing Versus no Packing; a Randomized Control Trial.
• Actual Study Start Date: Mar 1, 2020
• Anticipated Primary Completion Date: Jul 1, 2021
• Anticipated Study Completion Date: Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Perianal abscess cavity packing	Procedure: No packing of perianal abscess cavity; introducing new method to no packing of abscess cavity.
Experimental: Perianal abscess cavity no packing	Procedure: No packing of perianal abscess cavity; introducing new method to no packing of abscess cavity.

Outcome Measures

Primary Outcome Measures

1. Post-operative pain [14 days]

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

Secondary Outcome Measures

1. Decreases hospital visit [3 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr Ruth K.M Pfau Civil Hospital	Karachi	Sindh	Pakistan	75000

Sponsors and Collaborators

• Dow University of Health Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lajpat Rai, Principal Investigator, Dow University of Health Sciences
• ClinicalTrials.gov Identifier: NCT04832529
• Other Study ID Numbers: IRB-1537/DUHS/Approval/2020
• First Posted: Apr 5, 2021
• Last Update Posted: Apr 5, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Abscess

Study Results

No Results Posted as of Apr 5, 2021