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

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.

Study Overview

• Status: Completed
• Conditions: Seborrheic Keratosis; Acrochordon
• Intervention / Treatment: Drug: Sodium Fusidate 2 % Topical Ointment; Drug: Petrolatum ointment

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Dermatology and Venereology Clinic, Dr. Cipto Mangunkusumo National Central General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: Sodium Fusidate 2 % Topical Ointment; Sodium fusidate 2% topical ointment was applied twice daily on the wound after cauterization for 14 days.; Other Names: Fucidin ointment
PLACEBO_COMPARATOR: 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.	Drug: Petrolatum ointment; Petrolatum ointment was applied twice daily on the wound after cauterization for 14 days.; Other Names: Vaseline album

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Incidence of infection	Presence of wound infection, established by findings of pain, erythema, edema, and poor reepithelization	14 days

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Firman Parrol, MD, Indonesia University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ACTUAL): May 31, 2021
• Study Completion (ACTUAL): May 31, 2021

Study Registration Dates

• First Submitted: April 23, 2022
• First Submitted That Met QC Criteria: April 23, 2022
• First Posted (ACTUAL): April 29, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 5, 2022
• Last Update Submitted That Met QC Criteria: April 29, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: wound healing; cauterization; sodium fusidate ointment; petrolatum
• Additional Relevant MeSH Terms: Skin Diseases; Keratosis; Keratosis, Seborrheic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Dermatologic Agents; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Emollients; Petrolatum; Fusidic Acid
• Other Study ID Numbers: 20-11-1406

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No