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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A | Experimental | class I pullulan based medical device containing Allium cepa & HA |
|
| Group B | Active Comparator | class I medical device silicone gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kaloidon Plus | Device | topical application; twice daily |
| |
| silicone gel |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Vancouver Scar Scale (VSS) | Change of Vancouver Scar Scale (VSS) from baseline to weeks 4,8 and 12.
| week 4,8,12 |
| Change of Manchester Scale | Change of Manchester Scale from baseline to weeks 4,8 and 12.
| 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). |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Subjects affected by spontaneous keloids
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| Name | Affiliation | Role |
|---|---|---|
| Elena Campione | University of Rome Tor Vergata | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elena Campione | Roma | 00133 | Italy | |||
| Tor Vergata Univerisity Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37629638 | Derived | Cosio T, Costanza G, Coniglione F, Romeo A, Iacovelli F, Diluvio L, Dika E, Shumak RG, Rossi P, Bianchi L, Falconi M, Campione E. From In Silico Simulation between TGF-beta Receptors and Quercetin to Clinical Insight of a Medical Device Containing Allium cepa: Its Efficacy and Tolerability on Post-Surgical Scars. Life (Basel). 2023 Aug 21;13(8):1781. doi: 10.3390/life13081781. |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D007627 | Keloid |
| D017439 | Cicatrix, Hypertrophic |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003095 | Collagen Diseases |
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| Device |
topical application; twice daily |
|
| 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 |
| Rome |
| 00133 |
| Italy |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |