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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Pilonidal Sinus

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No