Celotres for Improvement in Wound Healing and Resulting Scar Consequences Following Suturing of a Wound (PMCS EURO HEAL)

Halscion

Status: Completed

Conditions: Scar

Treatments: Other: Celotres; Other: Surgical Closure by Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT01706848

HAL-0297

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Celotres

Active Comparator group

Description:

Scar halves randomized to treatment with device, opposite side treated per standard of care.

Treatment:

Other: Celotres

Standard surgical wound closure

Active Comparator group

Description:

Scar halves randomized to treatment with device, opposite side treated per standard of care.

Treatment:

Other: Surgical Closure by Standard of Care