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

Pilonidal Sinus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01081522
• Other study ID #: CW-0510-09-U352
• Status: Completed
• Phase: N/A
• First received: March 4, 2010
• Last updated: March 4, 2010
• Start date: October 2009
• Est. completion date: February 2010

Study information

• Verified date: March 2010
• Source: ConvaTec Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyDenmark: Danish Medicines Agency
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pilonidal Sinus

Locations

Country	Name	City	State
Denmark	Hillerod Hospital	Hillerod	Dk 3400
United Kingdom	Wound Healing Research Unit	Heath Park	Cardiff
United Kingdom	Scunthorpe General Hospital	Scunthorpe	North Lincolnshire

Sponsors (1)

Lead Sponsor	Collaborator
ConvaTec Inc.

Countries where clinical trial is conducted

Denmark,  United Kingdom,