Therapeutic Efficacy of Erbium:YAG Laser in Postpartum Patients With Episiotomy Scars
NCT ID: NCT05793476
Last Updated: 2025-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
5 participants
INTERVENTIONAL
2022-08-04
2025-01-01
Brief Summary
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Er:YAG laser is a non-invasive and non-ablative procedure that strengthens the connective tissue in the vaginal wall. It provides controlled thermal energy and causes shrinkage of collagen fibrils of the vaginal epithelium and lamina propria. It also induces neocollagenesis, elastogenesis and neoangiogenesis by temperature change. Er:YAG laser is also an effective modality to treat the scar tissue formed after the mediolateral episiotomy since it is a matter of functionality and esthetics. By tissue remodeling effect Er:YAG laser will improve the scar tissue of episiotomy and ameliorate the vulvar pain.
In this study, the therapeutic effect of Er:YAG laser on the tissue healing of the episiotomy scars and the reduction of vulvar pain.
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Detailed Description
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Er:YAG laser is a non-invasive and non-ablative procedure that strengthens the connective tissue in the vaginal wall. It provides controlled thermal energy and causes shrinkage of the collagen fibrils in the vaginal epithelium and lamina propria. It also induces neocollagenesis, elastogenesis and neoangiogenesis by temperature change. With minimum damage to the peripheral tissue, the viable cells in the target tissue react to this temperature change by expressing heat shock proteins (HSP). Then, HSP increases the levels of transforming growth factor-beta, fibroblast growth factor, epidermal growth factor, platelet-derived growth factor, vascular epithelial growth factor which induce neocollagenesis and neoangiogenesis. Therefore, the thermal energy stored in the vaginal wall induces proliferation of the epithelium which is rich in glycogen, neovascularization and collagen production in the lamina propria. Er:YAG laser is also an effective modality to treat the scar tissue formed after the mediolateral episiotomy since it is a matter of functionality and esthetics. By tissue remodeling effect Er:YAG laser will improve the scar tissue of episiotomy and ameliorate the vulvar pain.
In this study, the therapeutic effect of Er:YAG laser on the tissue healing of the episiotomy scars and the reduction of vulvar pain.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Fotona Dynamis Er:YAG Laser System Arm
Non-ablative thermal-only Er:YAG laser treatment using R11 and PS03 handpieces
Fotona Dynamis Er:YAG Laser System
The patient receives 2940 nm Er:YAG Laser (XS Dynamis, Fotona, Slovenia) at intervals of 15-21 days. She receives 3 sessions, in total. 5% Lidocaine cream is applied 30 minutes before each procedure. Each session consists of application of R11 handpiece to the episiotomy scar at Turbo3 Micro Short Pulse mode, with spot size of 2 mm, fluence of 9.5-10 j/cm2, frequency of 2 Hz and 4 pulses per point and 3 passes followed by PS03 handpiece at Basic Long Pulse mode, with spot size of 5 mm, energy of 800 mJ, frequency of 1.4 Hz and 4 pulses per point and 2 passes.
Fotona Dynamis Er:YAG Laser System with Sham handpience
The same procedure is applied but with a sham handpiece.
Fotona Dynamis Er:YAG Laser System with Sham handpiece
The same procedure is applied above but with a sham handpiece and parameter presentations masked.
Interventions
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Fotona Dynamis Er:YAG Laser System
The patient receives 2940 nm Er:YAG Laser (XS Dynamis, Fotona, Slovenia) at intervals of 15-21 days. She receives 3 sessions, in total. 5% Lidocaine cream is applied 30 minutes before each procedure. Each session consists of application of R11 handpiece to the episiotomy scar at Turbo3 Micro Short Pulse mode, with spot size of 2 mm, fluence of 9.5-10 j/cm2, frequency of 2 Hz and 4 pulses per point and 3 passes followed by PS03 handpiece at Basic Long Pulse mode, with spot size of 5 mm, energy of 800 mJ, frequency of 1.4 Hz and 4 pulses per point and 2 passes.
Fotona Dynamis Er:YAG Laser System with Sham handpiece
The same procedure is applied above but with a sham handpiece and parameter presentations masked.
Eligibility Criteria
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Inclusion Criteria
* Have given birth in the last 6 months with episiotomy
* Have vulvar pain and dyspareunia
Exclusion Criteria
* History of other diseases that can cause vulvar pain (neurological, dermatological, Infectious etc.)
18 Years
FEMALE
No
Sponsors
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Fotona d.o.o.
INDUSTRY
Istanbul University - Cerrahpasa
OTHER
Responsible Party
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Cemal Tamer Erel
Clinical Professor
Principal Investigators
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Cemal Tamer Erel, Prof.
Role: PRINCIPAL_INVESTIGATOR
Istanbul University - Cerrahpasa
Locations
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Istanbul University-Cerrahpasa
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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E-83045809-604.01.01-416311
Identifier Type: -
Identifier Source: org_study_id
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