Low Level Laser Therapy for Better Wound Healing

Prospective Double Blind Controlled Trial of Low Level Laser Therapy - Cesarean Section or Vaginal Tear or Episiotomy

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

Study Overview

• Status: Recruiting
• Conditions: Surgical Scar Tissue of Cesarean Section or Vaginal Tear or Episiotomy
• Intervention / Treatment: Device: Low-level laser therapy; Device: "Fake" low-level laser therapy

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joscha Reinhard, Prof. Dr.; Phone Number: 1249 +49 69-7939; Email: Joscha.Reinhard@artemed.de
• Study Contact Backup: Name: Midwifes; Phone Number: 1249 +49 69-7939

Study Locations

• Germany
  • Hessen
    • Frankfurt, Hessen, Germany, 60439
      • Recruiting
      • Prof. Dr. Joscha Reinhard
      • Contact: Prof. Dr. Joscha Reinhard, MBBS, BSc(Hon); Phone Number: 1249 +49697939; Email: Joscha.Reinhard@artemed.de
      • Contact: Prof. Dr. Joscha Midwifes; Phone Number: 1249 +49697939; Email: Joscha.Reinhard@artemed.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low-level laser therapy; Laser pen with low-level laser therapy.	Device: Low-level laser therapy; Low-level laser therapy ca. 72 Joules per cm2
Sham Comparator: Sham no low-level laser therapy; Identical laser pen without the low-level laser production.	Device: "Fake" low-level laser therapy; Identical laser pen without production of low-level laser therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	Visual analog scale (1= no pain; 10 = severe pain)	Questionnaire 3 to 4 days after birth, after 1 month after birth & after 3 months after birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
subjective would healing	Visual analog scale (1= very good healing; 10 = very bad would healing)	Questionnaire 3 to 4 days after birth, after 1 month after birth & after 3 months after birth

Collaborators and Investigators

• Sponsor: St. Elisabethen Krankenhaus Frankfurt GmbH
• Investigators: Principal Investigator: Joscha Reinhard, Prof. Dr., St. Elisabethenkrankenhaus Frankfurt

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: January 23, 2024
• First Posted (Actual): January 24, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix
• Other Study ID Numbers: FLaser

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No