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.

Study Overview

• Status: Completed
• Conditions: Pilonidal Sinus

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Denmark
  • Dk 3400
    • Hillerod, Dk 3400, Denmark
      • Hillerod Hospital
• United Kingdom
  • Cardiff
    • Heath Park, Cardiff, United Kingdom, CF 14 4XN
      • Wound Healing Research Unit
  • North Lincolnshire
    • Scunthorpe, North Lincolnshire, United Kingdom, DN 15 7BH
      • Scunthorpe General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

secondary care clinics

Description

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

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: ConvaTec Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (ACTUAL): February 1, 2010
• Study Completion (ACTUAL): February 1, 2010

Study Registration Dates

• First Submitted: March 4, 2010
• First Submitted That Met QC Criteria: March 4, 2010
• First Posted (ESTIMATE): March 5, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): March 5, 2010
• Last Update Submitted That Met QC Criteria: March 4, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Cysts; Pilonidal Sinus
• Other Study ID Numbers: CW-0510-09-U352