A Preliminary, Non-comparative Study to Evaluate a Bioresorbable Wound Scaffold in Acute Wounds
- 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
- Subjects with a history of skin sensitivity to any of the components of the study
- 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