NCT02521402

Pilot Study to Evaluate Clinical Outcomes With the Use of Biovance Following Keloid Scar Revision Surgery

Pilot Study to Evaluate Clinical Outcomes With the Use of Biovance, a Dehydrated Decellularized Human Amnion Membrane Allograft, Following Keloid Revision Surgery

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Golla Center for Plastic Surgery · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Keloid Scar

Interventions

Type	Name	Description
BIOLOGICAL	Biovance	decellularized, dehydrated human amniotic membrane

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-12-01
• Completion: 2017-06-01
• First posted: 2015-08-13
• Last updated: 2015-08-13

Locations

1 site across 1 country: United States