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

Completed

Brief 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 & 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

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Locations (3): Hillerod Hospital
🇩🇰
Hillerod, Dk 3400, Denmark
Wound Healing Research Unit
🇬🇧
Heath Park, Cardiff, United Kingdom
Scunthorpe General Hospital
🇬🇧
Scunthorpe, North Lincolnshire, United Kingdom

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