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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01081522
First Posted: March 5, 2010
Last Update Posted: March 5, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
ConvaTec Inc.
  Purpose
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.

Condition
Pilonidal Sinus

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Preliminary, Non-comparative Study to Evaluate a Bioresorbable Wound Scaffold in Acute Wounds

Resource links provided by NLM:


Further study details as provided by ConvaTec Inc.:

Biospecimen Retention:   Samples With DNA
tissue (3mm punch biopsy)

Enrollment: 12
Study Start Date: October 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
secondary care clinics
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01081522


Locations
Denmark
Hillerod Hospital
Hillerod, Dk 3400, Denmark
United Kingdom
Wound Healing Research Unit
Heath Park, Cardiff, United Kingdom, CF 14 4XN
Scunthorpe General Hospital
Scunthorpe, North Lincolnshire, United Kingdom, DN 15 7BH
Sponsors and Collaborators
ConvaTec Inc.
Investigators
Study Director: Dheerendra Kommala, MD ConvaTec Inc.
  More Information

Responsible Party: Dheerendra Kommala, MD, Convatec Inc.
ClinicalTrials.gov Identifier: NCT01081522     History of Changes
Other Study ID Numbers: CW-0510-09-U352
First Submitted: March 4, 2010
First Posted: March 5, 2010
Last Update Posted: March 5, 2010
Last Verified: March 2010

Additional relevant MeSH terms:
Pilonidal Sinus
Cysts
Neoplasms