Class I Medical Device on Post-surgical Scars

Study Overview
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Brief Summary
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To compare the effect of a class I pullulan based medical device containing Allium cepa & HA versus a class I medical device silicone gel on new post-surgical wounds

Detailed Description
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A head-to-head, randomised, pivotal controlled trial evaluating the appearance of post-surgical scars for 12 weeks. The study was developed in 10 months, including recruitment, evaluation every 4 weeks and evaluation of the secondary objective in the third month (T2). The primary endpoint was the evaluation of the effectiveness of the class I medical device contain onion (Allium cepa) extract compared to the silicone gel used in the treatment of post-surgical scars for the prevention of hypertrophic scars. Objective scar assessment using the Vancouver Scar Scale (VSS), Manchester Scale, Patient and Observer Scar Assessment Scale (POSAS), itching, redness and pliability were performed after 4,8 and 12 weeks of treatment. Safety was also evaluated by gathering adverse events related to application of the gel. The statistical analysis of the data was carried out by applying parametric or non-parametric tests depending on the distribution of the data that was going to be obtained. The one-way analysis of variance ANOVA test was used to evaluate the reduction/increase of clinical parameters in the pre-established observation times (T0, T2, T3 and T4) for each treatment, whereas comparison between treatments was performed via t-test analysis. Correlation tests were also used. The differences were considered statistically significant for p values <0.05.

Official Title
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Head-to-head, Randomized Pivotal Study to Evaluate the Effect of a Class I Pullulan Based Medical Device Containing Allium Cepa and Hyaluronic Acid Compared to Class I Medical Device Silicone Gel on Post-surgical Scars

Conditions
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Cicatrix, Post-Surgical Complication, Scar Itching, Keloid, Hypertrophic Scar

Intervention / Treatment
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* Device: Kaloidon Plus
* Device: silicone gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects aged between 18 and 70 who have undergone surgery for the excision of skin lesions at least 20 days before the start of the protocol. Exclusion Criteria: Subjects affected by spontaneous keloids Diabetic subjects with a previous history of disorders in the repair of wounds; Subjects with overinfected wounds after the first week after surgery; Subjects with documented sensitivity to silicone gel; Subjects affected by collagen disorders (e.g. Pseudoxantoma elasticum, poikilodermatosis).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A<br>class I pullulan based medical device containing Allium cepa & HA | Device: Kaloidon Plus<br>* topical application; twice daily<br>|
| Active Comparator: Group B<br>class I medical device silicone gel | Device: silicone gel<br>* topical application; twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Vancouver Scar Scale (VSS) | Change of Vancouver Scar Scale (VSS) from baseline to weeks 4,8 and 12. vascularity(range from normal(0 point) to purple(3point) pigmentation(range from normal(0 point) to hyper-pigmentation(3point) pliability(range from normal(0 point) to contracture(5point) height (range from flat(0 point) to above 5mm(3point) pain(range from none(0 point) to Require medication(2point) itchiness(range from none(0 point) to Require medication(2point) We assess total score that are minimum score is 0 and maximum is 18. The lowest score means the best scar condition. | week 4,8,12 | 
| Change of Manchester Scale | Change of Manchester Scale from baseline to weeks 4,8 and 12. Color (range from perfect (1 point) to Gross mismatch (4 points) Shine ( from matte (1 point) to shiny (2 points)) Contour ( from Flush with surrounding skin (1 point) to keloid (4 points)) Distortion ( from none (1 point) to severe (4 points)) Lower score denotes a better outcome using the MSS (range: 4-14). | week 4,8,12 | 
| Change of Patient and Observer Scar Assessment Scale (POSAS) from baseline to weeks 4,8 and 12. | Change of Patient and Observer Scar Assessment Scale (POSAS) from baseline to weeks 4,8 and 12. Lower score denotes a better outcome using the POSAS (range: 0-10). | week 4,8,12 | 
| Change of itching from baseline to weeks 4,8 and 12 | Change of itching from baseline to weeks 4,8 and 12 will be measure with the visual analogue scale (VAS). Lower score denotes a better outcome using the VAS (range: 0-10). | week 4,8,12 | 
| Change of redness from baseline to weeks 4,8 and 12 | Change of redness from baseline to weeks 4,8 and 12 will be evaluted as 10 points scale, from normal (1 point) to purple (10 points). Lower score denotes a better outcome (range: 0-10). | week 4,8,12 | 
| Change of pliability from baseline to weeks 4,8 and 12 | Change of pliability from baseline to weeks 4,8 and 12 will be measured by testing folding of the scar with a six-step scale: normal, supple, yielding, firm, banding, and contracture. Lower score denotes a better outcome (range: 0-10). | week 4,8,12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events occurrence after treatment | Incidence of adverse events will be evaluated since the baseline visit until 12 weeks after the end of the treatment. Adverse Events reported by patients or noticed by investigator will be reported as local skin reactions. | week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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scar, Keloid, Cicatrix, allium cepa, silicone