Celotres for Improvement in Wound Healing and Resulting Scar Consequences Following Suturing of a Wound

Halscion, Inc.60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Scar

Interventions

CelotresOTHER

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.

Surgical Closure by Standard of CareOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (9)

Angelius Szpital Proviat

Katowice, Poland

Oddzial Leczenia Oparzen Chirugil Plastysznej

Krakow, Poland

Wojskowy Oddzial Kliniczny ChirurgiiPlastycznej

Warsaw, Poland

The Westbourne Center

Birmingham, United Kingdom

Outcomes

Primary Outcomes

Safety

Safety as defined by the incidence of device related adverse events.

Time frame: Assessed at treatment, suture removal, Months 1, 3, 6, 9 and 12

Secondary Outcomes

Effectiveness

Patient and Observer Scar Assessment Scale (POSAS)

Time frame: Assessed at Months 1, 3, 6, 9 and 12

Device Performance Evaluation

Questions related to packaging integrity and successful administration of product as assessed by the Principal Investigator

Time frame: Assessed at Day 1

Data from ClinicalTrials.gov

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