Role of Alcohol in Prevention of Recurrence of the Accidentally Opened Angular Dermoid Cyst
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Beni-Suef University
- Enrollment
- 60
- Locations
- 3
- Primary Endpoint
- post-operative inflammation
Study Overview
Brief Summary
Purpose to evaluate the effect of alcohol used in accidentally opened dermoid cyst in prevention of inflammation and recurrence Patient and method: Itt is a comparative interventional study ,performed on 60 patients with external angular dermoid cysts that were accidentally opened during surgical removal , they were divided into two groups ,Group (A) includes 30 patients where only saline was used to wash the surgical field while group(B) includes 30 patients where ethyl alcohol 70% was used.
Detailed Description
- Study Design and Rationale:
This is a comparative interventional study designed to evaluate the efficacy of 70% ethyl alcohol in preventing inflammation and recurrence in cases of accidentally opened external angular dermoid cysts during surgical removal. The rationale for using 70% ethyl alcohol is based on its antimicrobial and antiseptic properties, which may reduce the risk of postoperative infection and cyst recurrence compared to saline irrigation alone. 2. Patient Recruitment and Group Allocation:
Recruitment Sites: Patients were recruited from outpatient clinics at Beni-Suef University Hospitals, Fayoum University Hospitals, and MUST University Hospital.
Recruitment Period: May 2022 to May 2024.
Group Allocation:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Year to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical diagnosis of external angular dermoid cyst.
- •Accidental opening of the dermoid cyst during surgical removal.
- •Age: Patients of any age eligible for surgical intervention.
- •Willingness to provide written informed consent for participation in the study.
Exclusion Criteria
- •Recurrent dermoid cysts (previously treated or excised).
- •Complicated dermoid cysts (e.g., preoperatively ruptured or infected).
- •Patients with contraindications to the use of ethyl alcohol (e.g., known hypersensitivity or allergy).
- •Patients with systemic conditions that may impair wound healing (e.g., uncontrolled diabetes, immunocompromised states).
- •Patients who are pregnant or breastfeeding.
- •Patients unable or unwilling to comply with follow-up visits.
Arms & Interventions
Group (A)
only saline was used to wash the surgical field
Intervention: external angular dermoid cysts surgical removal (Procedure)
group (B)
ethyl alcohol 70% was used to wash the surgical field
Intervention: external angular dermoid cysts surgical removal (Procedure)
Outcomes
Primary Outcomes
post-operative inflammation
Time Frame: 6 month
The primary outcome of post-operative inflammation measures the incidence of clinically significant inflammatory responses at the surgical site following excision of an accidentally opened external angular dermoid cyst. Inflammation is defined as the presence of two or more of the following clinical signs: Erythema (redness) extending ≥1 cm from the wound edges. Edema (swelling) at or around the surgical site. Local warmth compared to adjacent skin. Pain or tenderness reported by the patient or elicited during palpation. Purulent discharge from the incision site.
Secondary Outcomes
- recurrence(6 month)
Investigators
Mohamed Yasser Sayed Saif
Dean of National Institute of Longevity Elder Sciences - Professour of Ophthalmology
Beni-Suef University