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Low Level Laser Therapy for Better Wound Healing

S

St. Elisabethen Krankenhaus Frankfurt GmbH

Status

Enrolling

Conditions

Surgical Scar Tissue of Cesarean Section or Vaginal Tear or Episiotomy

Treatments

Device: "Fake" low-level laser therapy
Device: Low-level laser therapy

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full description

After surgical suture application of low level laser therapy of ca. 72 Joules / cm2.

Evaluation at discharge, after 1 months & 3 months.

Enrollment

50 estimated patients

Sex

Female

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

50 participants in 2 patient groups

Low-level laser therapy
Active Comparator group
Description:
Laser pen with low-level laser therapy.
Treatment:
Device: Low-level laser therapy
Sham no low-level laser therapy
Sham Comparator group
Description:
Identical laser pen without the low-level laser production.
Treatment:
Device: "Fake" low-level laser therapy

Trial contacts and locations

1

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Central trial contact

Joscha Reinhard, Prof. Dr.; Midwifes

Data sourced from clinicaltrials.gov

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