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Elastography Changes in Cesarean Scar After Negative Pulsed Pressure Treatment

NCT06057792 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-10-25

No results posted yet for this study

Summary

The application of pulsed negative pressure to the scar tissue stimulates the cellular response, producing elastic changes in the tissue, quantifiable by ultrasound, not only in terms of thickness but also in the elastic capacity of the tissues, measured by quantified elastography.

Conditions

  • Cesarean Scar
  • Elastography

Interventions

DEVICE

negative pulsed pressure AeroFlow system

For the application of pulsatile negative pressure, the AeroFlow® equipment will be used, carried out by one of the researchers participating in the project.The application will be carried out addressing the structure of interest (scar), following the protocol established by INDIBA to release adhesions between the different depth planes. The work will consist of an application of pulsed negative pressure using suction cups, which will work automatically at a frequency and intensity tolerable by the patient. Treatment protocol in 2 phases Total application time 15min 1. Static cup: preparation: Prepare the tissue surrounding the scar. 5min 2. Dynamic Cup: work: Lock the tissue around the scar and the scar itself.10min Suction mode: continuous with continuous sliding of the cup The number of treatment sessions will consist of a total of 6 sessions, so there will be two sessions over 3 weeks.

Sponsors & Collaborators

  • Universidad de Granada

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-30
Primary Completion
2024-02-11
Completion
2024-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06057792 on ClinicalTrials.gov