Low Level Laser Therapy for Better Wound Healing | NCT06220786

Studies
Low Level Laser Therapy for Better Wound Healing

NCT06220786

Sponsor

St. Elisabethen Krankenhaus Frankfurt GmbH

Status

Unknown status

Last Update Posted

Apr 17, 2024Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Surgical Scar Tissue of Cesarean Section or Vaginal Tear or Episiotomy

Interventions

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

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 19, 2023Actual

Primary Completion Date

Jun 1, 2024Estimated

Completion Date

Jun 1, 2024Estimated

First Submitted Date

Dec 19, 2023

First Submission Date that Met QC Criteria

Jan 23, 2024

First Posted Date

Jan 24, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2024

Last Update Posted Date

Apr 17, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Dr. Joscha Reinhard, Specialist registrar, St. Elisabethen Krankenhaus Frankfurt GmbHPrincipal Investigator

Lead Sponsor

St. Elisabethen Krankenhaus Frankfurt GmbHOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low-level laser therapy	Active Comparator	Laser pen with low-level laser therapy.	Device: Low-level laser therapy
Sham no low-level laser therapy	Sham Comparator	Identical laser pen without the low-level laser production.	Device: "Fake" low-level laser therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Low-level laser therapy	Device	Low-level laser therapy ca. 72 Joules per cm2	Low-level laser therapy

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Joscha Reinhard, Prof. Dr.	Contact	+49 69-7939	1249	Joscha.Reinhard@artemed.de
Midwifes	Contact	+49 69-7939	1249

Overall Officials

Name	Affiliation	Role
Joscha Reinhard, Prof. Dr.	St. Elisabethenkrankenhaus Frankfurt	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prof. Dr. Joscha Reinhard	Recruiting	Frankfurt am Main	Hesse	60439	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D028022	Low-Level Light Therapy

Ancestor Terms

ID	Term
D053685	Laser Therapy
D013812	Therapeutics
D010789	Phototherapy

Browse Leaves

Not provided

Browse Branches

Not provided

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