CompletedNot Applicable

Class I Medical Device on Post-surgical Scars

Italy64 participantsStarted 2022-05-01

Plain-language 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

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change of Vancouver Scar Scale (VSS)

Timeframe: week 4,8,12

Change of Manchester Scale

Timeframe: week 4,8,12

Change of Patient and Observer Scar Assessment Scale (POSAS) from baseline to weeks 4,8 and 12.

Timeframe: week 4,8,12

Change of itching from baseline to weeks 4,8 and 12

Timeframe: week 4,8,12

Change of redness from baseline to weeks 4,8 and 12

Timeframe: week 4,8,12

Change of pliability from baseline to weeks 4,8 and 12

Timeframe: week 4,8,12

Trial details

NCT IDNCT05412745

SponsorUniversity of Rome Tor Vergata

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-10

View on ClinicalTrials.gov More Cicatrix trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change of Vancouver Scar Scale (VSS)

Timeframe: week 4,8,12

Change of Manchester Scale

Timeframe: week 4,8,12

Change of Patient and Observer Scar Assessment Scale (POSAS) from baseline to weeks 4,8 and 12.

Timeframe: week 4,8,12

Change of itching from baseline to weeks 4,8 and 12

Timeframe: week 4,8,12

Change of redness from baseline to weeks 4,8 and 12

Timeframe: week 4,8,12

Change of pliability from baseline to weeks 4,8 and 12

Timeframe: week 4,8,12