Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-03-06 @ 1:48 PM
Study NCT ID:
NCT02521402
Status:
UNKNOWN
Last Update Posted:
2015-08-13
First Post:
2015-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study to Evaluate Clinical Outcomes With the Use of Biovance Following Keloid Scar Revision Surgery
Sponsor:
Golla Center for Plastic Surgery
Organization:
Study Overview
Official Title:
Pilot Study to Evaluate Clinical Outcomes With the Use of Biovance, a Dehydrated Decellularized Human Amnion Membrane Allograft, Following Keloid Revision Surgery
Status:
UNKNOWN
Status Verified Date:
2015-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: