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
  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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dheerendra Kommala, MD, Convatec Inc.
ClinicalTrials.gov Identifier: NCT01081522     History of Changes
Other Study ID Numbers: CW-0510-09-U352
Study First Received: March 4, 2010
Last Updated: March 4, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Pilonidal Sinus
Cysts
Neoplasms

ClinicalTrials.gov processed this record on August 20, 2014