NCT05412745

Class I Medical Device on Post-surgical Scars

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: University of Rome Tor Vergata · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

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

Interventions

Type	Name	Description
DEVICE	Kaloidon Plus	topical application; twice daily
DEVICE	silicone gel	topical application; twice daily

Timeline

• Start date: 2022-05-01
• Primary completion: 2022-09-10
• Completion: 2022-09-10
• First posted: 2022-06-09
• Last updated: 2022-09-14

Locations

2 sites across 1 country: Italy