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Ten (10) adult female subjects that had a caesarean surgery performed.Study will be conducted in 1 site.
Each subject will receive three treatments on one area that was randomly chosen. The other area will be left untreated and will serve as a control.
The objective is to Evaluate the clinical impact of UltraPulse fractional carbon dioxide laser treatment on the appearance of a Caesarean Scar (CS) as compared to a similar untreated scar side.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scar Revision | Experimental | Caesarean Scar Revision using Lumenis UltraPulse Encore. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumenis UltraPulse Encore. | Device | Treatment using Lumenis UltraPulse Encore. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Scar Evaluation | VSS , POSAS, Appearance assessment-Evaluation of the scar by blinded investigator. | 3 month following the 3rd treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Scar Evaluation. | VSS assessment -Evaluation of the scar by blinded investigator. | At base line , at the 3rd treatment and at the 1, 3 and 6 months follow-up |
| POSAS assessment | POSAS assessment by blinded Investigator and subject |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Merete Hædersdal, dr. med., ph.d. | Dermato-venerologisk Afdeling D42 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermato-venerologisk Afdeling D42 | Copenhagen | Bispebjerg Bakke 23 | 2400 | Denmark |
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| At base line , at the 3rd treatment and at the 1, 3 and 6 months follow-up |
| Scar Thickness and Uniformity | A High Definition Ultrasound (US) device will be used to generate a high resolution image of the skin layers of the treated and non-treated scar in order to measure and compare changes in scar thickness and uniformity. | At base line, at the 3rd treatment and at the 1, 3 and 6 months follow-up |
| Scar color | Colorimeter will be used for color measurement. | At base line, at the 3rd treatment and at the 1, 3 and 6 months follow-up. |
| Histochemical Changes in scar tissue | Histochemical analysis of scar tissue with different staining for analysis of changes following treatment:
| Immediately before the 2nd, and 3rd treatment |
| Subject's satisfaction | Subject's satisfaction of the treatment using a Satisfaction Scale as follows: None; Slight; Moderate; Good; Very Good. | At the 3rd treatment and at the 1, 3 and 6 month follow-up |