CicatrixNCT05412745
Class I Medical Device on Post-surgical Scars
A study testing Kaloidon Plus and silicone gel in people with Cicatrix and Post-Surgical Complication, run by University of Rome Tor Vergata at 2 sites in Italy.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cicatrix, Post-Surgical Complication, Scar Itching
- What is being tested?
- Kaloidon Plus and silicone gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesItaly
- Study dates
- 1 May 2022to 10 Sep 2022
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Elena Campione
Roma, 00133
Tor Vergata Univerisity Hospital
Rome, 00133
About this study
Official title: 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
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
Read the detailed description
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.
- Conditions
- Cicatrix, Post-Surgical Complication, Scar Itching, Keloid, Hypertrophic Scar
- Being tested
- Kaloidon Plus, silicone gel
- Keywords
- scar, Keloid, Cicatrix, allium cepa, silicone
- Medical subject headings
- Cicatrix, Keloid, Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kaloidon PlusDevice
topical application; twice daily
silicone gelDevice
topical application; twice daily
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | class I pullulan based medical device containing Allium cepa \& HA Receives: Device: Kaloidon Plus |
| Group B | Active comparator | class I medical device silicone gel Receives: Device: silicone gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: week 4,8,12
Secondary outcomes (1)
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.
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start1 May 2022
- Primary completion10 Sep 2022
- Study completion10 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CicatrixStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Campione, University of Rome Tor Vergata
- Investigators
- Elena Campione, Principal investigator, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412745
- Sponsor's protocol ID
- R.S. 211.19
- Status last verified
- Sep 2022
- First submitted
- 25 May 2022
- Last updated
- 14 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37629638