MILTA vs Placebo Use Comparison for the Management of Pain Related to Perineal Scars Following Delivery

NAActive, not recruitingINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

March 15, 2022

Primary Completion Date

March 23, 2023

Study Completion Date

July 23, 2025

Conditions
Perineal ScarsDelivery ComplicationEpisiotomyPainTreatment
Interventions
OTHER

MILTA probe

"Each woman will be included within the 6h after delivery (to ensure at least 2 days with the treatment / placebo). Once the written informed consent is obtained, the patient will be randomized in one of the 2 groups (MILTA or Placebo): 2 sessions are planned (the first one between 6h and 24h after delivery and the second one day after the first session). The woman will be lying on an exam bed. After a skin cleansing, the MILTA probe covered with a specific single use protection will be placed facing the scar. A 10-min session will include 5 min with the analgesia mode on followed with 5 min with the healing mode on in the MILTA group. For the placebo group, the procedure will be identical, with the probe switched OFF. To ensure that the red light is observable in the bedroom in both groups, a second probe will be used, facing the ceiling of the exam bedroom (and not the woman) for the 10 minutes of the procedure."

OTHER

placebo probe

"Each woman will be included within the 6h after delivery (to ensure at least 2 days with the treatment / placebo). Once the written informed consent is obtained, the patient will be randomized in one of the 2 groups (MILTA or Placebo): 2 sessions are planned (the first one between 6h and 24h after delivery and the second one day after the first session). The woman will be lying on an exam bed. After a skin cleansing, the MILTA probe covered with a specific single use protection will be placed facing the scar. A 10-min session will include 5 min with the analgesia mode on followed with 5 min with the healing mode on in the MILTA group. For the placebo group, the procedure will be identical, with the probe switched OFF. To ensure that the red light is observable in the bedroom in both groups, a second probe will be used, facing the ceiling of the exam bedroom (and not the woman) for the 10 minutes of the procedure."

Trial Locations (1)

80054

CHU Amiens Picardie, Amiens

All Listed Sponsors
lead

Centre Hospitalier Universitaire, Amiens

OTHER