Scar
Conditions
Brief summary
The objective of the study is to actively gather additional information on safety, device performance and possible emergent risks following the use of Celotres in a post-market setting when used to improve wound healing and the resulting scar consequences following suturing of a wound.
Interventions
OTHERCelotres
Surgical procedure will be performed as per the standard of care. Scar halves randomized to treatment with device (Celotres), opposite side treated per standard of care.
OTHERSurgical Closure by Standard of Care
Surgical procedure will be performed as per the standard of care. Scar halves randomized to treatment with device (Celotres), opposite side treated per standard of care.
Sponsors
Halscion, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients electing to undergo a surgical procedure; * Patients able and willing to give written informed consent
Exclusion criteria
* Patients with a known or potential risk of allergy or sensitivity to products or substances containing porcine gelatin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | Assessed at treatment, suture removal, Months 1, 3, 6, 9 and 12 | Safety as defined by the incidence of device related adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness | Assessed at Months 1, 3, 6, 9 and 12 | Patient and Observer Scar Assessment Scale (POSAS) |
| Device Performance Evaluation | Assessed at Day 1 | Questions related to packaging integrity and successful administration of product as assessed by the Principal Investigator |
Countries
Poland, United Kingdom
Outcome results
None listed