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Completed

NCT Number: NCT05353374

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Sodium Fusidate 2 % Topical Ointment

Drug

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

Other names: Fucidin ointment

Petrolatum ointment

Drug

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

Other names: Vaseline album

Primary outcomes

  1. Wound healing score

    Time frame: 14 days

    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

Secondary outcomes

  1. Erythema

    Time frame: 14 days

    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%)

  2. Edema

    Time frame: 14 days

    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%)

  3. Crusts

    Time frame: 14 days

    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%)

  4. Reepithelization

    Time frame: 14 days

    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)

  5. Incidence of infection

    Time frame: 14 days

    Presence of wound infection, established by findings of pain, erythema, edema, and poor reepithelization

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 29, 2022
Registry last updated
May 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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