Clinical trial NCT05353374: Effectiveness of Sodium Fusidate Ointment Compared to Petrolatum for Wound Healing Following Cauterization
Official title: Effectiveness of Sodium Fusidate Ointment Compared to Petrolatum for Wound Healing Following Cauterization: A Double-Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Seborrheic Keratosis
Acrochordon
Keywords: wound healing
cauterization
sodium fusidate ointment
petrolatum
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Wound healing score
timeFrame: 14 days
Secondary outcomes:
measure: Erythema
timeFrame: 14 days
measure: Edema
timeFrame: 14 days
measure: Crusts
timeFrame: 14 days
measure: Reepithelization
timeFrame: 14 days
measure: Incidence of infection
timeFrame: 14 days
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Dermatology and Venereology Clinic, Dr. Cipto Mangunkusumo National Central General Hospital
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Firman Parrol, MD
role: PRINCIPAL_INVESTIGATOR
References: