Class I Medical Device on Post-surgical Scars

NCT05412745 | Completed

• 1 other identifier: R.S. 211.19
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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

Conditions

Cicatrix; Post-Surgical Complication; Scar Itching; Keloid; Hypertrophic Scar

Keywords

scar; Keloid; Cicatrix; allium cepa; silicone

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Incidence of adverse events occurrence after treatment

  week 12

Study Arms (2)

group A

EXPERIMENTAL

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

Device: Kaloidon Plus

Group B

ACTIVE COMPARATOR

class I medical device silicone gel

Device: silicone gel

Interventions

Kaloidon Plus DEVICE

topical application; twice daily

group A

silicone gel DEVICE

topical application; twice daily

Group B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Study Sites (2)

Elena Campione

Roma, 00133, Italy

Location

Tor Vergata Univerisity Hospital

Rome, 00133, Italy

Location

Related Publications (1)

• 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.

  PMID: 37629638 DERIVED

MeSH Terms

Conditions

Cicatrix; Keloid; Cicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Elena Campione

  University of Rome Tor Vergata

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Elena Campione

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: June 9, 2022
• Study Start: May 1, 2022
• Primary Completion: September 10, 2022
• Study Completion: September 10, 2022
• Last Updated: September 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)