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The objective of the study is to evaluate the initial safety and efficacy of MF-4181, a hydrogel scaffold, in the reduction of the volume, appearance, and/or symptoms associated with keloid scarring in subjects undergoing surgical revision of keloid scars.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrogel scaffold (MF-4181) | Device | Following surgical removal of the ear keloid, the incision will be treated with MF-4181. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Device safety | Device safety is defined as the incidence of device related adverse events. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Device efficacy | Evaluations of cosmesis, induration, erythema and pigmentation will be evaluated by the investigator. | 12 months |
| Device efficacy | Volume and linear measurements will be taken by the investigator |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Srikanth Garikaparthi, MD | Princess Margaret Hospital, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Hospital | Nassau | The Bahamas |
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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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| 12 months |
| Device efficacy | Subject evaluation of cosmesis, pain, tenderness, itching and scar satisfaction will be obtained. | 12 months |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |