NCT05353374

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Sodium Fusidate 2 % Topical Ointment	Sodium fusidate 2% topical ointment was applied twice daily on the wound after cauterization for 14 days.
DRUG	Petrolatum ointment	Petrolatum ointment was applied twice daily on the wound after cauterization for 14 days.

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-05-31
• Completion: 2021-05-31
• First posted: 2022-04-29
• Last updated: 2022-05-05

Locations

1 site across 1 country: Indonesia