Class I Medical Device on Post-surgical Scars

NCT ID: NCT05412745

Last Updated: 2022-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2022-09-10

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

group A

class I pullulan based medical device containing Allium cepa \& HA

Group Type: EXPERIMENTAL

Kaloidon Plus

Intervention Type: DEVICE

topical application; twice daily

Group B

class I medical device silicone gel

Group Type: ACTIVE_COMPARATOR

silicone gel

Intervention Type: DEVICE

topical application; twice daily

Interventions

Kaloidon Plus

topical application; twice daily

Intervention Type: DEVICE

silicone gel

topical application; twice daily

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rome Tor Vergata

OTHER

Sponsor Role: lead

Responsible Party

Elena Campione

Professor Elena Campione

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elena Campione

Role: PRINCIPAL_INVESTIGATOR

University of Rome Tor Vergata

Locations

Elena Campione

Roma, , Italy

Tor Vergata Univerisity Hospital

Rome, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 37629638 (View on PubMed)

Other Identifiers

R.S. 211.19

Identifier Type: -

Identifier Source: org_study_id