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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Chitosan cream
DeviceApplication of Chitosan cream twice daily for 8 weeks
Silicone Gel
DeviceApplication of silicone gel twice a day for 8 weeks
Olive Oil Topical Oil
DeviceApplication of olive oil twice daily for 8 weeks
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
Side effects
Patients are to report any side effects that they experience with use of any topical application. Side effects encountered are recorded.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.