Low Level Laser Therapy for Better Wound Healing

Not Applicable

Recruiting

• Conditions: Surgical Scar Tissue of Cesarean Section or Vaginal Tear or Episiotomy

• 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.

Study Timeline

• Study Start: 2023-12-19
• Study First Submitted: 2023-12-19
• Study First Submitted QC: 2024-01-23
• Study First Posted: 2024-01-24
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01

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

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