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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Keloid Revision Surgery with Biovance | Other | All enrolled patients will have Biovance applied during Keloid Revision Surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biovance | Biological | decellularized, dehydrated human amniotic membrane |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of keloid scar recurrence after revision surgery with placement of Biovance | Published data in the literature reporting on keloid scar incidence and recurrence without the use of Biovance may serve as a reference/historical control. | 1 year post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcomes of keloid scar revision surgery, including scar size and appearance | 1 year post-surgery | |
| Incidence of complications (including infection, incision dehiscence, hematoma, seroma, and wound necrosis following revision surgery | 1 year post-surgery |
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Inclusion Criteria:
The subject has:
Exclusion Criteria:
The subject has:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dinakar Golla, MD | Contact | 412-963-6677 | drgolla@gollaplasticsurgery.com |
| Name | Affiliation | Role |
|---|---|---|
| Dinakar Golla, MD | Golla Center for Plastic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Golla Center for Plastic Surgery | Pittsburgh | Pennsylvania | 15236 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17644502 | Result | Durani P, Bayat A. Levels of evidence for the treatment of keloid disease. J Plast Reconstr Aesthet Surg. 2008;61(1):4-17. doi: 10.1016/j.bjps.2007.05.007. Epub 2007 Jul 19. | |
| 20927486 | Result | Gauglitz GG, Korting HC, Pavicic T, Ruzicka T, Jeschke MG. Hypertrophic scarring and keloids: pathomechanisms and current and emerging treatment strategies. Mol Med. 2011 Jan-Feb;17(1-2):113-25. doi: 10.2119/molmed.2009.00153. Epub 2010 Oct 5. |
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| ID | Term |
|---|---|
| D007627 | Keloid |
| ID | Term |
|---|---|
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002921 | Cicatrix |
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| 24527306 | Result | Viera MH, Vivas AC, Berman B. Update on Keloid Management: Clinical and Basic Science Advances. Adv Wound Care (New Rochelle). 2012 Oct;1(5):200-206. doi: 10.1089/wound.2011.0313. |
| 5352921 | Result | Alhady SM, Sivanantharajah K. Keloids in various races. A review of 175 cases. Plast Reconstr Surg. 1969 Dec;44(6):564-6. doi: 10.1097/00006534-196912000-00006. No abstract available. |
| 15140214 | Result | Marneros AG, Norris JE, Watanabe S, Reichenberger E, Olsen BR. Genome scans provide evidence for keloid susceptibility loci on chromosomes 2q23 and 7p11. J Invest Dermatol. 2004 May;122(5):1126-32. doi: 10.1111/j.0022-202X.2004.22327.x. |
| 15365369 | Result | Lee JY, Yang CC, Chao SC, Wong TW. Histopathological differential diagnosis of keloid and hypertrophic scar. Am J Dermatopathol. 2004 Oct;26(5):379-84. doi: 10.1097/00000372-200410000-00006. |
| 26061491 | Result | Smiell JM, Treadwell T, Hahn HD, Hermans MH. Real-world Experience With a Decellularized Dehydrated Human Amniotic Membrane Allograft. Wounds. 2015 Jun;27(6):158-69. |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |