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

NCT ID: NCT05353374

Last Updated: 2022-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2021-05-31

Brief 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.

Detailed 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.

Conditions

Seborrheic Keratosis; Acrochordon

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sodium fusidate ointment

Electrosurgery was carried out using Ellman® Surgitron. The tissue was cleaned using sterile gauze or a cotton swab that had been moistened with 0.9% NaCl. Following electrosurgery, sodium fusidate ointment was applied to the wound according to the allocation sequence. The patient also received a wound care instruction sheet. Each subject was given two or four pots of ointment that should be applied twice daily on the wound.

Group Type: EXPERIMENTAL

Sodium Fusidate 2 % Topical Ointment

Intervention Type: DRUG

Sodium fusidate 2% topical ointment was applied twice daily on the wound after cauterization for 14 days.

Petrolatum

Electrosurgery was carried out using Ellman® Surgitron. The tissue was cleaned using sterile gauze or a cotton swab that had been moistened with 0.9% NaCl. Following electrosurgery, petrolatum was applied to the wound according to the allocation sequence. The patient also received a wound care instruction sheet. Each subject was given two or four pots of ointment that should be applied twice daily on the wound.

Group Type: PLACEBO_COMPARATOR

Petrolatum ointment

Intervention Type: DRUG

Petrolatum ointment was applied twice daily on the wound after cauterization for 14 days.

Interventions

Sodium Fusidate 2 % Topical Ointment

Sodium fusidate 2% topical ointment was applied twice daily on the wound after cauterization for 14 days.

Intervention Type: DRUG

Petrolatum ointment

Petrolatum ointment was applied twice daily on the wound after cauterization for 14 days.

Intervention Type: DRUG

Other Intervention Names

Fucidin ointment; Vaseline album

Eligibility Criteria

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).

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Firman Parrol

Dermatology Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Firman Parrol, MD

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Locations

Dermatology and Venereology Clinic, Dr. Cipto Mangunkusumo National Central General Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

Countries

Indonesia

Other Identifiers

20-11-1406

Identifier Type: -

Identifier Source: org_study_id