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A Preliminary, Non-comparative Study to Evaluate a Bioresorbable Wound Scaffold in Acute Wounds

This study has been completed.
Sponsor:
Information provided by:
ConvaTec Inc.
ClinicalTrials.gov Identifier:
NCT01081522
First received: March 4, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted

March 4, 2010
March 4, 2010
October 2009
February 2010   (final data collection date for primary outcome measure)
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No Changes Posted
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A Preliminary, Non-comparative Study to Evaluate a Bioresorbable Wound Scaffold in Acute Wounds
A Preliminary, Non-comparative Study to Evaluate a Bioresorbable Wound Scaffold in Acute Wounds

As this is a proof-of-concept study, the primary objective is to provide preliminary data on the safety and efficacy of Bioresorbable Wound Scaffold in the management of acute wounds left to heal by secondary intent.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

tissue (3mm punch biopsy)
Non-Probability Sample

secondary care clinics
Pilonidal Sinus
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
February 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects over 18 years, willing and able to provide written informed consent.
  • Subjects who have an excised pilonidal sinus wound left to heal by secondary intent.
  • Subjects who are willing to commit to having two biopsies being taken during the study.

Exclusion Criteria:

  • Subjects with a history of skin sensitivity to any of the components of the study product
  • Subjects whose wound is infected
  • Subjects who have participated in a previous clinical study within the past 3 months
  • Subjects' with a known history of poor compliance with medical treatments
  • Subjects who are pregnant (where pregnancy is a possibility, a pregnancy testing kit will be provided)
  • Necrotic/sloughy wounds unless surgically debrided prior to enrolment
  • Medical or emotional risk associated with the potential biopsy that outweighs the risk of not taking a biopsy as determined by the investigator
  • Subjects exhibiting any other medical condition which, according to the Investigator, justifies the subject's exclusion from the study
  • Subjects with impaired renal function
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   United Kingdom
 
NCT01081522
CW-0510-09-U352
Not Provided
Dheerendra Kommala, MD, Convatec Inc.
ConvaTec Inc.
Not Provided
Study Director: Dheerendra Kommala, MD ConvaTec Inc.
ConvaTec Inc.
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP