Role of Alcohol in Prevention of Recurrence of the Accidentally Opened Angular Dermoid Cyst

NCT06816316 | Completed

• 1 other identifier: FMBSUREC/01102024/Saeed
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Dermoid Cyst; Choristomas

Keywords

dermoid cyst; ethyl alcohol; choristomas; lipogranulomatous inflammatory

Outcome Measures

Primary Outcomes (1)

• post-operative inflammation

  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.

  6 month

Secondary Outcomes (1)

• recurrence

  6 month

Study Arms (2)

Group (A)

PLACEBO COMPARATOR

only saline was used to wash the surgical field

Procedure: external angular dermoid cysts surgical removal

group (B)

ACTIVE COMPARATOR

ethyl alcohol 70% was used to wash the surgical field

Procedure: external angular dermoid cysts surgical removal

Interventions

external angular dermoid cysts surgical removal PROCEDURE

Skin incision was done below the eyebrow, subcutaneous and orbicularis dissection was done to remove the cysts. Upon accidental opening of the cyst then removal of the cyst walls and its contents from the surgical field as much as possible was done. At this step, in group (A) only saline was used to wash the surgical field from any remnants. In group (B) the surgical field was cleaned with a gauze soaked with ethyl alcohol 70%. Then closure of the wound in both groups.

Group (A); group (B)

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (3)

Fayoum University Hospital

Al Fayyum, Faiyum Governorate, Egypt

Location

Beni Suef University

Banī Suwayf, Egypt

Location

Misr University For Science and Technology

Giza, Egypt

Location

MeSH Terms

Conditions

Dermoid Cyst; Choristoma

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Teratoma; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of National Institute of Longevity Elder Sciences - Professour of Ophthalmology

Study Record Dates

• First Submitted: April 28, 2024
• First Posted: February 10, 2025
• Study Start: January 1, 2019
• Primary Completion: December 31, 2023
• Study Completion: May 30, 2024
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (3)