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The objective of the study is to evaluate the safety and preliminary efficacy of MF-4181, a hydrogel scaffold, in improving scars and their resulting consequences following abdominoplasty or laparoscopy/laparotomy gynecologic procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MF-4181 | Active Comparator | Scar halves randomized to treatment with device, opposite side treated per standard of care |
|
| Standard surgical wound closure | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MF-4181 | Other | Surgical procedure will be performed as per the standard of care. Scar halves randomized to treatment with device (MF-4181), opposite side treated per standard of care. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety, defined as the absence of device related serious adverse events at 3 months post last MF-4181 treatment | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator and Subject Observer Scar Assessment Scale (POSAS) | 12 months | |
| Investigator and Subject Anchored Visual Analog Scar Evaluation Scale | 12 Months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wlodzimierz Baranowski, MD | Unaffliated | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| II Katedra i Klinika Ginekologii Onkologicznej i Ginekologii | Lublin | Poland | ||||
| Klinika Ginekologii Operacyjnej |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Standard surgical wound closure | Other | Surgical procedure will be performed as per the standard of care. Scar halves randomized to treatment with device (MF-4181), opposite side treated per standard of care. |
|
| Digital photographs evaluated by independent medical experts |
| 12 Months |
| Lublin |
| Poland |
| Klinika Ginekologii i Ginekologii Onkologicznej | Warsaw | Poland |