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Class I Medical Device on Post-surgical Scars

NCT05412745 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2022-09-14

No results posted yet for this study

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

Interventions

DEVICE

Kaloidon Plus

topical application; twice daily

DEVICE

silicone gel

topical application; twice daily

Sponsors & Collaborators

  • University of Rome Tor Vergata

    lead OTHER

Principal Investigators

  • Elena Campione · University of Rome Tor Vergata

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2022-09-10
Completion
2022-09-10

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05412745 on ClinicalTrials.gov