Keloid Scar
Conditions
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.
Interventions
BIOLOGICALBiovance
decellularized, dehydrated human amniotic membrane
Sponsors
Golla Center for Plastic Surgery
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
The subject has: 1. been diagnosed with a keloid scar 2. a keloid scar that is located on the face, neck, arm, trunk, or groin area 3. is between the ages of 21 and 80 years old 4. competency as an adult, per applicable state law who is willing to provide written informed consent 5. the intent and ability to return for all scheduled and required visits and follow recommended standard post surgical treatment for keloid scar excision.
Exclusion criteria
The subject has: 1. clinical evidence of infection of the keloid scar 2. any malignancy or a neoplasm at the keloid scar site 3. any significant comorbid disease that may interfere with wound healing, known active Hepatitis A, B, or C or Acquired Immune Deficiency Syndrome or is known to be infected with HIV, a known collagen disorder or autoimmune disease \[including systemic lupus erythematosis (SLE), rheumatoid arthritis (RA),fibromyalgia, polymyositis, scleroderma, ankylosing spondylitis, dermatomyositis, osteogenesis imperfecta or the inherited disorders of Sjogren, Larsen, Raynaud, Ehlers-Danlos or Marfan syndrome\] 4. received chemotherapy, radiotherapy, immunosuppressives or corticosteroids (greater than 10 mg prednisone-equivalent per day) within the past 30 days. 5. a known history of abuse of alcohol or drugs (prescribed or illegal), significant psychiatric personality or psychotic disorder requiring chronic psychotropic therapy, or gross noncompliance to recommended therapies 6. condition(s) that would adversely affect subject safety by following the protocol 7. any contraindication for use of Biovance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of keloid scar recurrence after revision surgery with placement of Biovance | 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. |
Secondary
| Measure | 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 |
Countries
United States
Contacts
Primary ContactDinakar Golla, MD
Outcome results
None listed