Surgical Scar Tissue of Cesarean Section or Vaginal Tear or EpisiotomyNCT06220786
Low Level Laser Therapy for Better Wound Healing
A study testing Low-level laser therapy and "Fake" low-level laser therapy in people with Surgical Scar Tissue of Cesarean Section or Vaginal Tear or Episiotomy, run by St. Elisabethen Krankenhaus Frankfurt GmbH at 1 site in Germany.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Scar Tissue of Cesarean Section or Vaginal Tear or Episiotomy
- What is being tested?
- Low-level laser therapy and "Fake" low-level laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 19 Dec 2023to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caesarean section or perineal tear grade 1-4 or episiotomy
- competent in German language
Who cannot join
- no caesarean section or birth without perineal tear grad 1-4 / episiotomy
- No consent given
Trial locations and contacts
1 site in 1 country.
Midwifes contact
Germany1 site, 1 recruiting
- Recruiting
Prof. Dr. Joscha Reinhard
Frankfurt am Main, Hesse, 60439
Prof. Dr. Joscha Reinhard, MBBS, BSc(Hon), +49697939 ext. 1249, Joscha.Reinhard@artemed.de
Prof. Dr. Joscha Midwifes, +49697939 ext. 1249, Joscha.Reinhard@artemed.de
About this study
Official title: 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
Read the detailed description
After surgical suture application of low level laser therapy of ca. 72 Joules / cm2.
Evaluation at discharge, after 1 months \& 3 months.
- Being tested
- Low-level laser therapy, "Fake" low-level laser therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-level laser therapyDevice
Low-level laser therapy ca. 72 Joules per cm2
"Fake" low-level laser therapyDevice
Identical laser pen without production of low-level laser therapy
| Study group | Role | What they receive |
|---|---|---|
| Low-level laser therapy | Active comparator | Laser pen with low-level laser therapy. Receives: Device: Low-level laser therapy |
| Sham no low-level laser therapy | Sham comparator | Identical laser pen without the low-level laser production. Receives: Device: "Fake" low-level laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Visual analog scale (1= no pain; 10 = severe pain)
Measured: Questionnaire 3 to 4 days after birth, after 1 month after birth & after 3 months after birth
Secondary outcomes (1)
subjective would healing
Visual analog scale (1= very good healing; 10 = very bad would healing)
Measured: Questionnaire 3 to 4 days after birth, after 1 month after birth & after 3 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start19 Dec 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Scar Tissue of Cesarean Section or Vaginal Tear or EpisiotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Elisabethen Krankenhaus Frankfurt GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Joscha Reinhard, St. Elisabethen Krankenhaus Frankfurt GmbH
- Investigators
- Joscha Reinhard, Prof. Dr., Principal investigator, St. Elisabethenkrankenhaus Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220786
- Sponsor's protocol ID
- FLaser
- Status last verified
- Apr 2024
- First submitted
- 19 Dec 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Double Blind Controlled Trial of Low Level Laser Therapy - Cesarean Section or Vaginal Tear or Episiotomy
- ClinicalTrials.gov ID
- NCT06220786
- Acronym / sponsor ID
- FLaser
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- St. Elisabethen Krankenhaus Frankfurt GmbHUniversity, hospital or other
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Low-level laser therapy | Active comparator | Device: Low-level laser therapyLaser pen with low-level laser therapy. |
| Sham no low-level laser therapy | Sham comparator | Device: "Fake" low-level laser therapyIdentical laser pen without the low-level laser production. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Caesarean section or perineal tear grade 1-4 or episiotomy
- competent in German language
Key exclusion criteria (2 listed)
- no caesarean section or birth without perineal tear grad 1-4 / episiotomy
- No consent given
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-level laser therapyLow-level laser therapy ca. 72 Joules per cm2 | Device | Low-level laser therapy |
| "Fake" low-level laser therapyIdentical laser pen without production of low-level laser therapy | Device | Sham no low-level laser therapy |
Primary outcome
Pain score
Time frame: 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)
1 secondary outcome
subjective would healing
Time frame: Questionnaire 3 to 4 days after birth, after 1 month after birth & after 3 months after birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Midwifes contact
Joscha Reinhard, Prof. Dr. principal investigator
St. Elisabethenkrankenhaus Frankfurt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-level laser therapy and "Fake" low-level laser therapy in people with Surgical Scar Tissue of Cesarean Section or Vaginal Tear or Episiotomy, run by St. Elisabethen Krankenhaus Frankfurt GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joscha Reinhard, Prof. Dr. (+49 69-7939 ext. 1249, Joscha.Reinhard@artemed.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: Questionnaire 3 to 4 days after birth, after 1 month after birth & after 3 months after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.