NCT06796933

Brief Summary

The purpose of the study will be to determine the effect of polarized light therapy (Bioptron) on scar formation after a cesarean section.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

January 27, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2025

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

2 months

First QC Date

January 22, 2025

Last Update Submit

January 22, 2025

Conditions

Cesarean Section

Outcome Measures

Primary Outcomes (2)

  • The Patient and Observer Scar Assessment Scale (POSAS)

    It is a comprehensive tool designed to evaluate scar quality from both the patient's and the observer's perspectives before and after treatment for all participants in both groups. This scale includes two separate assessments: one completed by the patient and the other by the healthcare professional observing the scar. Each part of the scale assesses different aspects of the scar, providing a holistic view of its impact and severity. Each scale assesses six scar characteristics: the observer evaluates vascularization, pigmentation, thickness, surface roughness, pliability, and surface area, while the patient rates pain, pruritus, color, thickness, relief, and pliability. All items are scored on a 10-point scale, with 1 indicating 'normal skin' and 10 representing the 'worst imaginable scar.' Higher total scores indicate poorer scar quality

    4 weeks

  • Vancouver scar scale

    The Vancouver Scar Scale (VSS) is a widely used tool for assessing the quality and severity of scars before and after treatment for all participants in both groups. The VSS helps clinicians objectively measure the effectiveness of treatments and track changes in scar characteristics over time The VSS rated the scars according to four parameters: vascularity, pigmentation, pliability, and height. Each parameter contained ranked subscales that may be summed to obtain a total score ranging from 0 (representing normal skin) to 13 (representing the worst scar imaginable).

    4 weeks

Secondary Outcomes (1)

  • Adheremeter

    4 weeks

Study Arms (2)

Silicone-based products group

ACTIVE COMPARATOR

The participants will be treated with cosmetic creams such as Silicone-based products, (silicone gels for 1 month).

Other: Silicon based products (silicon gel)

Bioptron and Silicone-based products group

EXPERIMENTAL

The participants will be treated by polarized light therapy (Bioptron) for 15 minutes, 3 sessions per week, in addition to the cosmetic creams (Silicone-based products; silicone gels) for one month.

Other: Silicon based products (silicon gel)Device: Bioptron (polarized light therapy)

Interventions

Silicon based products (silicon gel)OTHER

The participants will be treated with cosmetic creams such as Silicone-based products (silicone gels twice a day) for one month.

Bioptron and Silicone-based products groupSilicone-based products group
Bioptron (polarized light therapy)DEVICE

The participants will be treated by polarized light therapy (Bioptron) for 15 minutes, 3 sessions per week, for one month.

Bioptron and Silicone-based products group

Eligibility Criteria

Age20 Years - 30 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The participants' ages will be ranged from 20-30 years old.
  • Their body mass index (BMI) will not exceed 30 kg/m2.
  • They will be primipara and having abdominal scar after CS.
  • The scar age will be extended from 6 weeks to 6 months.
  • All women will be medically stable when attending the study.

You may not qualify if:

  • Pregnant women or women planning to become pregnant during the study period.
  • Women having diabetes mellitus.
  • Women taking immunosuppressant drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghadeer Abdelazim Mostafa

Banhā, Egypt

Location

Study Officials

  • Tamer Assar, Professor

    Benha University

    STUDY DIRECTOR

  • Mohamed Awad, Professor

    Cairo University

    STUDY CHAIR

Central Study Contacts

Ghadeer Mostafa, Master

CONTACT

01093973398zd94508@gmail.com

Amira Nagy, PHD

CONTACT

+201021177871dr.Amira.Nagy@cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 22, 2025

First Posted

January 28, 2025

Study Start

January 27, 2025

Primary Completion

March 18, 2025

Study Completion

March 31, 2025

Last Updated

January 28, 2025

Record last verified: 2025-01

Locations

EG(1)