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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06220786

Enrollment

Registered

2024-01-24

Start date

2023-12-19

Completion date

2024-06-01

Last updated

2024-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Scar Tissue of Cesarean Section or Vaginal Tear or Episiotomy

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.

Interventions

DEVICELow-level laser therapy

Low-level laser therapy ca. 72 Joules per cm2

DEVICEFake low-level laser therapy

Identical laser pen without production of low-level laser therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Masking description

Blinding of the two laser pens is in place till all patient data has been collected.

Intervention model description

Prospective randomized double blind study. Intervention 1: Low-level laser therapy ca. 72 Joules vs. Intervention 2: No Low-level laser therapy. Doctors & Patients do not kown which laser is the true laser or the fake laser

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

Germany

Contacts

Primary ContactJoscha Reinhard, Prof. Dr.

Joscha.Reinhard@artemed.de+49 69-7939

Backup ContactMidwifes

+49 69-7939

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026