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OpenTrials
Completed

NCT Number: NCT01706848

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

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.

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Key information

Conditions

Scar Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

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 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

Treatment and study plan

Celotres

Other

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 Care

Other

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.

Primary outcomes

  1. Safety

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

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

Secondary outcomes

  1. Effectiveness

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

    Patient and Observer Scar Assessment Scale (POSAS)

  2. 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 Clinical Study Evaluating the Safety, Device Performance and Possible Emergent Risks of Celotres in the Improvement of Wound Healing and the Resulting Scar Consequences Following Suturing of a Wound

Acronym: PMCS EURO HEAL

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.

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