Efficacy in Preventing Hypertrophic Scars: A Randomised Controlled Trial Comparing Chitosan Cream, Silicone Gel & Olive Oil

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversiti Sains Malaysia

About this trial

The goal of this clinical trial is to compare the efficacy of three different topical applications in preventing hypertrophic scars in adults with scars healed after suturing. The main question it aims to answer is: Is Chitosan cream effective in preventing hypertrophic scars?

Researchers will compare Chitosan cream with silicone gel and olive oil to see if there is any difference in their efficacies.

Participants will be randomly assigned to three groups, with each group using a different topical application. They will be instructed to:

* apply the topical application on their scar twice a day for 8 weeks * attend follow-up visits at 4, 12 and 24 weeks for a doctor to assess their scar and take clinical photographs * immediately inform the researcher if they experience any side effects

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with traumatic or surgical wounds which have healed by primary intention within 14 days

Length of scar at least 3cm

Disqualifiers

Patients with seafood allergy

Patients with scar from wounds that were complicated by infection or wound breakdown

Patients who have undergone scar treatment by other modalities

Patients with history of keloids / hypertrophic scars

Trial design

Design model

Parallel

Treatments tested in this trial

  • Chitosan cream

    Device

    Application of Chitosan cream twice daily for 8 weeks

  • Silicone Gel

    Device

    Application of silicone gel twice a day for 8 weeks

  • Olive Oil Topical Oil

    Device

    Application of olive oil twice daily for 8 weeks

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Silicone gelActive comparator 1 intervention
Group B: Chitosan creamExperimental treatment 1 intervention
Group C: Olive oilPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Patient and Observer Scar Assessment Scale (POSAS) scores

Each item is rated on a 5-point score. The lowest score is '1' which corresponds to the situation of normal skin. Score '5' being the largest difference from normal skin.

Time frame
Enrolment to 24 weeks
2

Scar Assessment and Rating (SCAR) Scale scores

Scores of clinical photographs of each scar by 3 plastic surgeons. Score '0' indicates conditions closest to normal skin. Maximum scores for each item range from 1 to 4, where higher scores indicate larger differences from normal skin.

Time frame
Enrolment to 24 weeks

Secondary outcomes

1

Side effects

Patients are to report any side effects that they experience with use of any topical application. Side effects encountered are recorded.

Time frame
Enrolment to 24 weeks

Other outcomes

Sponsors and contacts

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