Effectiveness of Sodium Fusidate Ointment Compared to Petrolatum for Wound Healing Following Cauterization

Seborrheic Keratosis Clinical Trial

Official title:

Effectiveness of Sodium Fusidate Ointment Compared to Petrolatum for Wound Healing Following Cauterization: A Double-Blind Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05353374
• Other study ID #: 20-11-1406
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: May 31, 2021

Study information

• Verified date: April 2022
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A double-blind within person randomized controlled trial study was conducted on 90 wounds in 22 subjects. All wounds were randomized to receive either sodium fusidate ointment or petrolatum following cauterization.

Description:

All eligible participants were randomized to be applied sodium fusidate ointment (intervention) or white petrolatum (control) on the lesions on their face with 1:1 ratio. Allocation sequence was generated by a statistician with a computer and it was concealed from the researchers and participants. The ointment was prepared and packaged by a pharmacist. Each pot was numbered in accordance with the allocation sequence.

Electrosurgery was carried out using Ellman® Surgitron. Prior to the cauterization, we performed infiltration anesthesia around the lesion with Pehacain® (containing 20 mg of lidocaine and 0.0125 mg/ml epinephrine). The tissue was cleaned using sterile gauze or a cotton swab that had been moistened with 0.9% NaCl. Following electrosurgery, sodium fusidate ointment or petrolatum was applied to the wound according to the allocation sequence. The patient also received a wound care instruction sheet. This sheet contained information on how to wash the face or body properly, how to apply the ointment properly, what to avoid after procedure (rubbing the wound excessively, use make up, sweating excessively, and use other topical agents on the wound), and follow-up instructions (on the 3rd, 7th, and 14th day). Each subject was given two or four pots of ointment that should be applied twice daily on the wound.

Wound monitoring, which includes erythema, edema, crusting, re-epithelialization, total wound healing score, pus, and subjective symptoms was performed on the 3rd, 7th, and 14th day. Erythema scores was also monitored immediately after electrosurgery. Monitoring can be done 1 day earlier or later than schedule in some cases since the wound healing phase is expected still the same. Clinical grading of each site was carried out using a 5-point analog scale for erythema, edema, crusting, re-epithelialization, and total wound healing score.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• age over 20 years

• clinically diagnosed with seborrheic keratosis or acrochordon

• having minimum of two lesions and maximum of four lesions with diameter of 4-10 mm on face or neck and minimum distance between lesions of 5 cm

• providing consent to participate into the study

Exclusion Criteria:

• a skin bacterial infection on the other parts of body's skin

• benign tumor lesions with inflammation or secondary infection

• history of antibiotics use in the last 2 weeks or long-acting penicillin injections within the past 1 month

• history of corticosteroids and immunosuppressants use in the past 2 weeks

• using a pacemaker

• infected with Coronavirus disease 2019 (Covid-19).

Related Conditions & MeSH terms

• Acrochordon
• Keratosis
• Keratosis, Seborrheic
• Seborrheic Keratosis

Intervention

Drug:
• Sodium Fusidate 2 % Topical Ointment
Sodium fusidate 2% topical ointment was applied twice daily on the wound after cauterization for 14 days.
• Petrolatum ointment
Petrolatum ointment was applied twice daily on the wound after cauterization for 14 days.

Locations

Country	Name	City	State
Indonesia	Dermatology and Venereology Clinic, Dr. Cipto Mangunkusumo National Central General Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healing score	Wound healing score was calculated based on the erythema, edema, crusts, and reepithelization. Wound healing score is as follows: 0-4 = very good/healed, 5-8 good/healed, 9-12 moderate/not healed, and 13-16 = poor/not healed	14 days
Secondary	Erythema	Skin erythema around the wound, assessed with physical examination. Erythema score is as follows: 0 = no erythema, 1 = mild erythema (25%), 2 = moderate erythema (50%), 3 = severe erythema (75%), and 4 = very severe erythema (100%)	14 days
Secondary	Edema	Edema on the wound area, assessed with physical examination. Edema score is as follows: 0 = no edema, 1 = mild edema (25%), 2 = moderate edema (50%), 3 = severe edema (75%), and 4 = very severe edema (100%)	14 days
Secondary	Crusts	Presence of crusts on the surface of the wound, assessed with physical examination. Crusts score is as follows: 0 = none, 1 = a few (1-30%), 2 = moderate (31-60%), 3 = a lot (61-90%), and 4 = generalized (91-100%)	14 days
Secondary	Reepithelization	Improvement of the wound characterized by decreasing size and depth of the wound, assessed with physical examination. Reepithelization score is as follows: 0 = complete (91-100%), 1 = good (61-90%), 2 = moderate (1-30%), and 4 = poor (0% or widening of the wound)	14 days
Secondary	Incidence of infection	Presence of wound infection, established by findings of pain, erythema, edema, and poor reepithelization	14 days