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

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

Study Overview

• Status: Completed
• Conditions: Cicatrix; Keloid; Hypertrophic Scar; Post-Surgical Complication; Scar Itching
• Intervention / Treatment: Device: Kaloidon Plus; Device: silicone gel

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00133
    • Elena Campione
  • Rome, Italy, 00133
    • Tor Vergata Univerisity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: group A; class I pullulan based medical device containing Allium cepa & HA	Device: Kaloidon Plus; topical application; twice daily
ACTIVE_COMPARATOR: Group B; class I medical device silicone gel	Device: silicone gel; topical application; twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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).	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).	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).	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).	week 4,8,12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	week 12

Collaborators and Investigators

• Sponsor: University of Rome Tor Vergata

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2022
• Primary Completion (ACTUAL): September 10, 2022
• Study Completion (ACTUAL): September 10, 2022

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (ACTUAL): June 9, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2022
• Last Update Submitted That Met QC Criteria: September 13, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: scar; Keloid; Cicatrix; silicone; allium cepa
• Additional Relevant MeSH Terms: Pathologic Processes; Connective Tissue Diseases; Fibrosis; Collagen Diseases; Cicatrix; Keloid; Cicatrix, Hypertrophic
• Other Study ID Numbers: R.S. 211.19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No