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

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.

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