Clinical trial NCT05412745: Class I Medical Device on Post-surgical Scars
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cicatrix
Post-Surgical Complication
Scar Itching
Keloid
Hypertrophic Scar
Keywords: scar
Keloid
Cicatrix
allium cepa
silicone
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

Primary outcomes:
measure: Change of Vancouver Scar Scale (VSS)
timeFrame: week 4,8,12
measure: Change of Manchester Scale
timeFrame: week 4,8,12
measure: Change of Patient and Observer Scar Assessment Scale (POSAS) from baseline to weeks 4,8 and 12.
timeFrame: week 4,8,12
measure: Change of itching from baseline to weeks 4,8 and 12
timeFrame: week 4,8,12
measure: Change of redness from baseline to weeks 4,8 and 12
timeFrame: week 4,8,12
measure: Change of pliability from baseline to weeks 4,8 and 12
timeFrame: week 4,8,12
Secondary outcomes:
measure: Incidence of adverse events occurrence after treatment
timeFrame: week 12
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Elena Campione
city: Rome
country: Italy
facility: Tor Vergata Univerisity Hospital
Study officials:
affiliation: University of Rome Tor Vergata
name: Elena Campione
role: PRINCIPAL_INVESTIGATOR
References: