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Completed

NCT Number: NCT01706861

A Post Market Study Evaluating the Safety, Device Perfomance and Possible Emergent Risks of Celotres in Preventing Recurrence in Keloid Lesions Treated Adjunctive to Surgical Excision

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 reduce the recurrence rate, volume, appearance and/or symptoms associated with keloid scarring in subjects undergoing surgical excision of keloids as compared to the scientific literature.

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Key information

Conditions

Earlobe Keloids

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Angelius Szpital Proviat, Katowice, Poland

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients electing to undergo keloid excision 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.

Treatment and study plan

Celotres

Device

Celotres following surgical removal of earlobe keloid.

Primary outcomes

  1. The incidence of device related adverse events

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

    Device safety is defined as the incidence of device related adverse events.

  2. Recurrence of keloid post scar excision

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

    Proportion of subjects with recurrence of keloid scar post excision defined as the presence of scar tissue volume >0.3cc

Secondary outcomes

  1. Patient and Observer Scar Assessment Scale (POSAS)

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

  2. Subject Dermatology Life Quality Index (DLQI)

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

  3. Device Performance Evaluation

    Time frame: Assessed at Day 1

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

Sponsors and collaborators

Lead sponsor

Halscion, Inc.

Industry

Registry information

Official study title

A Post Market Study Evaluating the Safety, Device Perfomance and Possible Emergent Risks of Celotres in Preventing Recurrence in Keloid LEsions Treated Adjunctive to suRgical Excision. PMCS: EURO-KLEAR

Acronym: EURO KLEAR

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 15, 2012
Registry last updated
May 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.