Keloid Scar Clinical Trial
Official title:
Pilot Study to Evaluate Clinical Outcomes With the Use of Biovance, a Dehydrated Decellularized Human Amnion Membrane Allograft, Following Keloid Revision Surgery
The main purpose of this study is to see if there is clinical benefit of using Biovance in reduction of the recurrence of keloids when used to revise them. It will also assess the postoperative complications.
To assess the performance of Biovance, patients will consulted regarding the history and
previous treatment of their keloid. Once patients are deemed to be appropriate candidates,
they will be enrolled in the study. Operatively, the old scar will be completely excised.
Then the Biovance will be laid in the base of the wound. After this is performed, extensive
undermining will be done to close the wound in layers.
All post-revision complications (including infection, incision dehiscence, hematoma, seroma,
and wound necrosis) will be assessed and recorded by the investigator. Patients will be
reviewed to obtain demographic and risk factor (such as age, body mass index, smoking) data.
Data on adjuvant therapy use (previous surgeries, treatments for keloid scar) will be
collected. Surgical technique details (such as incision size and closure technique) will
also be recorded for each patient. Photographs documenting the pre-, intra- and
post-revision clinical course of patients will be collected.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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