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Clinical Trials/NCT01706848
NCT01706848
Completed
Not Applicable

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

Halscion, Inc.9 sites in 2 countries60 target enrollmentSeptember 2012
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ConditionsScar

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Scar
Sponsor
Halscion, Inc.
Enrollment
60
Locations
9
Primary Endpoint
Safety
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
May 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Effectiveness(Assessed at Months 1, 3, 6, 9 and 12)
  • Device Performance Evaluation(Assessed at Day 1)

Study Sites (9)

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