Status:
COMPLETED
Class I Medical Device on Post-surgical Scars
Lead Sponsor:
University of Rome Tor Vergata
Conditions:
Cicatrix
Post-Surgical Complication
Eligibility:
All Genders
18-70 years
Phase:
NA
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 week...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2022
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT05412745
Start Date
May 1 2022
End Date
September 10 2022
Last Update
September 14 2022
Active Locations (2)
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1
Elena Campione
Roma, Italy, 00133
2
Tor Vergata Univerisity Hospital
Rome, Italy, 00133