Class I Medical Device on Post-surgical Scars

University of Rome Tor Vergata

Status

Completed

Conditions

Keloid

Cicatrix

Hypertrophic Scar

Scar Itching

Post-Surgical Complication

Treatments

Device: silicone gel

Device: Kaloidon Plus

Study type

Interventional

Funder types

Other

Identifiers

NCT05412745

R.S. 211.19

Details and patient eligibility

About

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

Full 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.

Enrollment

64 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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).