Health Condition 1: L910- Hypertrophic scar
Conditions
Interventions
Intervention1: Silicone Gel Sheet: Silicone Gel Sheet for scar management is composed of soft, semi occlusive polysiloxane material which has excellent bio - compatibility as per applicable EN ISO 109
Sponsors
Eucare Pharmaceuticals Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients who can understand, follow the specific instructions off the clinic as far as the application, removal, storage and re-application of the study product is concerned in a systematic manner. 2.Patient who can and willing to provide written Informed Consent 3. Patients with freshly re-epithelialized raised hypertrophic or keloid scars originated after normal wound healing and aged NOT more than 2 months and /or with freshly healed surgical incision wounds resulting in raised hypertrophic or keloid scars aged NOT more than 2 months. 4. Patients with hypertrophic or keloid scars of size 13 cm or below in length and 8 cm or below in width (to fit the study product dimension of 15x10 cm) 5. Patient who has not taken treatment for hypertrophic or keloid scars from past 4 weeks from the day of screening. 6. Patient with hypertrophic or keloid scars on those anatomical areas which are clinically feasible for the application of Silicone Gel Sheet for scar management as per the evaluation of the investigator. 7. Patient understands and is willing to participate in the clinical study and can comply with scheduled visits as per the protocol and the follow-up with study procedures.
Exclusion criteria
Exclusion criteria: 1.Patient with known allergy/hypersensitivity to silicone gel sheet or any of the individual polysiloxane components of Silicone Gel Sheet for scar management (Test device). 2. Patient having any medical or social condition that would, in the opinion of the investigator, place the subject at an unacceptable risk or render the subject unable to meet the requirements of the protocol. 3. Patient with hypertrophic or keloid scars older than 2 months from re-epithelialization (wound closure) as evaluated by the investigator. 4. Patients with hypertrophic or keloid scars longer than 13 cm in and wider than 8 cm (to fit the study product dimension of 15x10 cm). 5. Patient with body impressions that may appear like hypertrophic or keloid scars but actually do no not fall in those categories as per clinical assessment. 6. Patient with pitted and depressed scars as per clinical assessment. 7. Patient with Acute Respiratory Syndrome Coronavirus (SARSCoV)-2 infection confirmed by any confirmatory tests 8. Patient has participated in another clinical study involvinganother investigational agent within 4 weeks of the start of this trial or is planning participation in another clinical trial during the current study duration. 9. Patient with hypertrophic or keloid scars where it is difficult to apply the study product owing to the anatomical contours rendering it difficult for continuous maintenance of the study product. 10. Patient who have received hypertrophic or keloid scar treatment within 4 weeks of the first day of study treatment or planning to undergo another parallel treatment for hypertrophic or keloid scars. 11. Presence of any condition(s) which seriously compromises the patientâ??s ability to complete this study or has a known history of poor adherence with medical treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Number of Treatment Emergent Adverse Events (TEAEs) 2. Occurrence of Maceration of the scar edge and or edema during application or between the intervals of repeated daily applications 3. Occurrence of Irritation and persistent inflammation on the scar area and perimeter during application or between the intervals of repeated daily applicationsTimepoint: Screening period plus 8 week of treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in total scar area 2.Change in Scar Length Investigator will assess the scar length (denoted as L) It will be measured with ruler, from scar tip to tip and will record in cm Timepoint: [Time Frame: Assessed at Baseline visit (Day 0), Week 4 and Week 8];3. Change in Scar Width Investigator will assess the scar width (denoted as W) 4. Change (reduction) in the extent of Scar Induration 5. Change (reduction) in the extent of Scar Induration 6. Change (reduction) in Scar Erythema 7.Change (reduction/increase) in Overall Vancouver Scar Scale Score for 4 characteristics of the scar- Pigmentation, Vascularity, Pliability and height of the scar 8. Change in Overall Manchester Scar ScaleTimepoint: [Time Frame: Assessed at Baseline visit (Day 0), Week 4 and Week 8] | — |
Countries
India
Contacts
Public ContactMr Vairamuthu Ammaiyappan
Eucare Pharmaceuticals Private Limited
Outcome results
None listed