Dermoid CystNCT06816316
Role of Alcohol in Prevention of Recurrence of the Accidentally Opened Angular Dermoid Cyst
A study testing external angular dermoid cysts surgical removal in people with Dermoid Cyst and Choristomas, run by Beni-Suef University at 3 sites in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Dermoid Cyst, Choristomas
- What is being tested?
- external angular dermoid cysts surgical removal
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesEgypt
- Study dates
- 1 Jan 2019to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites
Fayoum University Hospital
Al Fayyum, Faiyum Governorate
Beni Suef University
Banī Suwayf
Misr University For Science and Technology
Giza
About this study
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.
Read the 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.
- 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: Group A (Control Group): 30 patients treated with saline irrigation. Group B (Intervention Group): 30 patients treated with 70% ethyl alcohol.
- Surgical Procedure: Preoperative Preparation: Patients were positioned supine, and the surgical site was sterilized using standard antiseptic protocols. Local or general anesthesia was administered based on patient and surgeon preference. Incision and Dissection: A skin incision was made below the eyebrow, followed by subcutaneous and orbicularis dissection to expose the dermoid cyst. Care was taken to avoid accidental rupture, but if the cyst was opened, the following steps were implemented. Cyst Management: The cyst walls and contents were meticulously removed from the surgical field to minimize residual material. Group A (Saline Group): The surgical field was irrigated with sterile saline solution to remove any remnants. Group B (Alcohol Group): The surgical field was cleaned using a gauze soaked with 70% ethyl alcohol to ensure thorough disinfection. Wound Closure: The wound was closed in layers using absorbable sutures for subcutaneous tissues and non-absorbable sutures or skin adhesive for the skin. A sterile dressing was applied.
- Postoperative Care: Medications: Both groups received the same regimen of systemic antibiotics (e.g., amoxicillin-clavulanate) and anti-inflammatory drugs (e.g., ibuprofen) for 5-7 days to prevent infection and inflammation. Follow-Up: Patients were monitored at 1 week, 1 month, 3 months, and 6 months postoperatively. At each visit, the surgical site was assessed for signs of inflammation, infection, or recurrence. Any adverse events or complications were recorded.
- Data Collection and Analysis: Data Collected: Demographic data (age, sex). Intraoperative details (cyst size, extent of spillage). Postoperative outcomes (infection, inflammation, recurrence). Statistical Methods: Data were analyzed using SPSS version 24. Quantitative variables (e.g., cyst size) were summarized as mean ± standard deviation. Categorical variables (e.g., recurrence rates) were summarized as frequencies and percentages. Comparisons between groups were performed using: ANOVA with post hoc tests for continuous variables. Chi-square test or Fisher's exact test for categorical variables. Pearson correlation coefficient was used to assess relationships between quantitative variables. A p-value < 0.05 was considered statistically significant.
- Technical Considerations: Ethyl Alcohol Concentration: 70% ethyl alcohol was chosen for its optimal balance between antimicrobial efficacy and tissue safety. Saline Irrigation: Sterile saline was used as a control to mimic standard surgical practice. Standardization: All procedures were performed by experienced surgeons to ensure consistency in technique and cyst management.
- Ethical and Regulatory Compliance: Informed Consent: Written informed consent was obtained from all participants prior to surgery. Ethical Approval: The study protocol was approved by the Ethics Committee of Beni-Suef University and adhered to the principles of the Helsinki Declaration. Patient Safety: Adverse events were monitored and managed promptly to ensure patient safety.
- Limitations: The study is limited by its sample size (n=60), which may affect the generalizability of the results. The follow-up period of 6 months may not be sufficient to capture long-term recurrence rates. Potential variability in surgical technique among different surgeons.
- Expected Outcomes:
The study aims to demonstrate that 70% ethyl alcohol is more effective than saline in reducing postoperative inflammation and recurrence in accidentally opened dermoid cysts.
If proven effective, this intervention could be incorporated into standard surgical protocols for dermoid cyst management.
- Conditions
- Dermoid Cyst, Choristomas
- Being tested
- external angular dermoid cysts surgical removal
- Keywords
- dermoid cyst, ethyl alcohol, choristomas, lipogranulomatous inflammatory
- Medical subject headings
- Dermoid Cyst, Choristoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
external angular dermoid cysts surgical removalProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group (A) | Placebo comparator | only saline was used to wash the surgical field Receives: Procedure: external angular dermoid cysts surgical removal |
| group (B) | Active comparator | ethyl alcohol 70% was used to wash the surgical field Receives: Procedure: external angular dermoid cysts surgical removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 month
Secondary outcomes (1)
recurrence
The recurrence outcome measures the number of participants who experience a reappearance of the external angular dermoid cyst at the surgical site within the 6-month follow-up period after surgical removal. Recurrence is defined as the presence of a palpable mass or radiologically confirmed lesion (via ultrasound or MRI) that exhibits characteristics consistent with a dermoid cyst. This outcome is a critical measure of the long-term efficacy of the surgical intervention and the intraoperative cleaning method (saline vs. 70% ethyl alcohol) in preventing residual cyst material from causing regrowth.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start1 Jan 2019
- Primary completion31 Dec 2023
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermoid CystStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Yasser Sayed Saif, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06816316
- Sponsor's protocol ID
- FMBSUREC/01102024/Saeed
- Status last verified
- Feb 2025
- First submitted
- 28 Apr 2024
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Alcohol in Prevention of Recurrence of the Accidentally Opened Angular Dermoid Cyst
- ClinicalTrials.gov ID
- NCT06816316
- Acronym / sponsor ID
- FMBSUREC/01102024/Saeed
- Conditions
- Dermoid Cyst, Choristomas
- Keywords
- dermoid cyst, ethyl alcohol, choristomas, lipogranulomatous inflammatory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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: Group A (Control Group): 30 patients treated with saline irrigation. Group B (Intervention Group): 30 patients treated with 70% ethyl alcohol.
- Surgical Procedure: Preoperative Preparation: Patients were positioned supine, and the surgical site was sterilized using standard antiseptic protocols. Local or general anesthesia was administered based on patient and surgeon preference. Incision and Dissection: A skin incision was made below the eyebrow, followed by subcutaneous and orbicularis dissection to expose the dermoid cyst. Care was taken to avoid accidental rupture, but if the cyst was opened, the following steps were implemented. Cyst Management: The cyst walls and contents were meticulously removed from the surgical field to minimize residual material. Group A (Saline Group): The surgical field was irrigated with sterile saline solution to remove any remnants. Group B (Alcohol Group): The surgical field was cleaned using a gauze soaked with 70% ethyl alcohol to ensure thorough disinfection. Wound Closure: The wound was closed in layers using absorbable sutures for subcutaneous tissues and non-absorbable sutures or skin adhesive for the skin. A sterile dressing was applied.
- Postoperative Care: Medications: Both groups received the same regimen of systemic antibiotics (e.g., amoxicillin-clavulanate) and anti-inflammatory drugs (e.g., ibuprofen) for 5-7 days to prevent infection and inflammation. Follow-Up: Patients were monitored at 1 week, 1 month, 3 months, and 6 months postoperatively. At each visit, the surgical site was assessed for signs of inflammation, infection, or recurrence. Any adverse events or complications were recorded.
- Data Collection and Analysis: Data Collected: Demographic data (age, sex). Intraoperative details (cyst size, extent of spillage). Postoperative outcomes (infection, inflammation, recurrence). Statistical Methods: Data were analyzed using SPSS version 24. Quantitative variables (e.g., cyst size) were summarized as mean ± standard deviation. Categorical variables (e.g., recurrence rates) were summarized as frequencies and percentages. Comparisons between groups were performed using: ANOVA with post hoc tests for continuous variables. Chi-square test or Fisher's exact test for categorical variables. Pearson correlation coefficient was used to assess relationships between quantitative variables. A p-value < 0.05 was considered statistically significant.
- Technical Considerations: Ethyl Alcohol Concentration: 70% ethyl alcohol was chosen for its optimal balance between antimicrobial efficacy and tissue safety. Saline Irrigation: Sterile saline was used as a control to mimic standard surgical practice. Standardization: All procedures were performed by experienced surgeons to ensure consistency in technique and cyst management.
- Ethical and Regulatory Compliance: Informed Consent: Written informed consent was obtained from all participants prior to surgery. Ethical Approval: The study protocol was approved by the Ethics Committee of Beni-Suef University and adhered to the principles of the Helsinki Declaration. Patient Safety: Adverse events were monitored and managed promptly to ensure patient safety.
- Limitations: The study is limited by its sample size (n=60), which may affect the generalizability of the results. The follow-up period of 6 months may not be sufficient to capture long-term recurrence rates. Potential variability in surgical technique among different surgeons.
- Expected Outcomes:
The study aims to demonstrate that 70% ethyl alcohol is more effective than saline in reducing postoperative inflammation and recurrence in accidentally opened dermoid cysts.
If proven effective, this intervention could be incorporated into standard surgical protocols for dermoid cyst management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A) | Placebo comparator | Procedure: external angular dermoid cysts surgical removalonly saline was used to wash the surgical field |
| group (B) | Active comparator | Procedure: external angular dermoid cysts surgical removalethyl alcohol 70% was used to wash the surgical field |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| external angular dermoid cysts surgical removalSkin 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. | Procedure or surgery | Group (A), group (B) |
Primary outcome
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.
1 secondary outcome
recurrence
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing external angular dermoid cysts surgical removal in people with Dermoid Cyst and Choristomas, run by Beni-Suef University at 3 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-operative inflammation (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.