Low Level Laser Therapy for Better Wound Healing
Not Applicable
Recruiting
- Conditions
- Surgical Scar Tissue of Cesarean Section or Vaginal Tear or Episiotomy
- Interventions
- Device: Low-level laser therapyDevice: "Fake" low-level laser therapy
- Registration Number
- NCT06220786
- Lead Sponsor
- St. Elisabethen Krankenhaus Frankfurt GmbH
- Brief Summary
Prospective randomized double blind study. Intervention 1: Low-level laser therapy ca. 72 Joules vs. Intervention 2: No Low-level laser therapy.
Outcome: Pain score \& would healing at discharge, 1 months \& 3 months
- Detailed Description
After surgical suture application of low level laser therapy of ca. 72 Joules / cm2.
Evaluation at discharge, after 1 months \& 3 months.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 50
Inclusion Criteria
- Caesarean section or perineal tear grade 1-4 or episiotomy
- competent in German language
Exclusion Criteria
- no caesarean section or birth without perineal tear grad 1-4 / episiotomy
- No consent given
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low-level laser therapy Low-level laser therapy Laser pen with low-level laser therapy. Sham no low-level laser therapy "Fake" low-level laser therapy Identical laser pen without the low-level laser production.
- Primary Outcome Measures
Name Time Method Pain score Questionnaire 3 to 4 days after birth, after 1 month after birth & after 3 months after birth Visual analog scale (1= no pain; 10 = severe pain)
- Secondary Outcome Measures
Name Time Method subjective would healing Questionnaire 3 to 4 days after birth, after 1 month after birth & after 3 months after birth Visual analog scale (1= very good healing; 10 = very bad would healing)
Trial Locations
- Locations (1)
Prof. Dr. Joscha Reinhard
🇩🇪Frankfurt, Hessen, Germany