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

Convatec

Status: Completed

Conditions: Pilonidal Sinus

Study type: Observational

Funder types: Industry

Identifiers

NCT01081522

CW-0510-09-U352

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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