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

University of Indonesia (UI)

Status: Completed

Conditions: Seborrheic Keratosis; Acrochordon

Treatments: Drug: Sodium Fusidate 2 % Topical Ointment; Drug: Petrolatum ointment

Study type: Interventional

Funder types: Other

Identifiers

NCT05353374

20-11-1406

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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22 participants in 2 patient groups, including a placebo group

Sodium fusidate ointment

Experimental group

Description:

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.

Treatment:

Drug: Sodium Fusidate 2 % Topical Ointment

Petrolatum

Placebo Comparator group

Description:

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.

Treatment:

Drug: Petrolatum ointment