Pilot Study to Evaluate Clinical Outcomes With the Use of Biovance Following Keloid Scar Revision Surgery
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|ClinicalTrials.gov Identifier: NCT02521402|
Recruitment Status : Unknown
Verified August 2015 by Golla Center for Plastic Surgery.
Recruitment status was: Not yet recruiting
First Posted : August 13, 2015
Last Update Posted : August 13, 2015
|Condition or disease||Intervention/treatment||Phase|
|Keloid Scar||Biological: Biovance||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study to Evaluate Clinical Outcomes With the Use of Biovance, a Dehydrated Decellularized Human Amnion Membrane Allograft, Following Keloid Revision Surgery|
|Study Start Date :||August 2015|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||June 2017|
Keloid Revision Surgery with Biovance
All enrolled patients will have Biovance applied during Keloid Revision Surgery
decellularized, dehydrated human amniotic membrane
- Incidence of keloid scar recurrence after revision surgery with placement of Biovance [ Time Frame: 1 year post-surgery ]Published data in the literature reporting on keloid scar incidence and recurrence without the use of Biovance may serve as a reference/historical control.
- Clinical outcomes of keloid scar revision surgery, including scar size and appearance [ Time Frame: 1 year post-surgery ]
- Incidence of complications (including infection, incision dehiscence, hematoma, seroma, and wound necrosis following revision surgery [ Time Frame: 1 year post-surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02521402
|Contact: Dinakar Golla, MDfirstname.lastname@example.org|
|United States, Pennsylvania|
|Golla Center for Plastic Surgery||Not yet recruiting|
|Pittsburgh, Pennsylvania, United States, 15236|
|Contact: Dinakar Golla, MD 412-963-6677 email@example.com|
|Principal Investigator:||Dinakar Golla, MD||Golla Center for Plastic Surgery|