Cesarean ScarELASTICFLOORNCT06057792
Elastography Changes in Cesarean Scar After Negative Pulsed Pressure Treatment
A study testing negative pulsed pressure AeroFlow system in people with Cesarean Scar and Elastography, run by Universidad de Granada at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Scar, Elastography
- What is being tested?
- negative pulsed pressure AeroFlow system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesSpain
- Study dates
- 30 Oct 2023to 30 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants aged between 18 and 60 years
- Who have undergone cesarean section surgery and therefore have a scar, lasting more than six months and less than 2 years.
- Patients who present a post-cesarean section scar with a fibrotic appearance and possible surrounding fascial restrictions.
Who cannot join
- Patients who present any neurological, inflammatory or orthopedic injury that prevents or alters balance, listening, vision or the cognitive abilities necessary to be able to answer appropriate questions or take questionnaires.
- Patients who present keloids in the scar.
- Patients who have contraindications to be treated with a 448kHz radiofrequency device such as:
- to. pregnant women b. Subjects with any type of electronic implants. c. Subjects presenting with thrombophlebitis
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Ana González
Málaga, 29018
Ana González, 661236109, anagonzalez.fisioterapeuta@gmail.com
Clínica Ana González
Málaga, 29018
ANA GONZÁLEZ, 661236109, anagonzalez.fisioterapeuta@gmail.com
About this study
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.
Read the detailed description
Participants will be recruited at the "Clínica Ana González" physiotherapy clinic. Once recruited, the physiotherapist Ana González Muñoz will carry out the assessment to determine the degree of eligibility of said participants and their inclusion or not in the study. The present study is designed as an open, controlled clinical trial. Two evaluations will be carried out on each participant before and after treatment. Participants who meet the required inclusion/exclusion criteria determined below will be included.
Participants will receive a Negative Pulsed Pressure treatment program with the AeroFlow® equipment. The measuring instruments to be used will be:
- Ultrasound machine.
Description of the ultrasound evaluation
Ultrasound evaluations will be performed. The participant will remain in all measurements. All measurements will be performed with a General Electric S7 R3 The evaluation of tissue quality will be carried out by pixel quantification, using the computer software included in the ultrasound equipment itself.
- Adheremeter Adheremeter is a new device designed to measure postsurgical scar adhesion which is defined as the restriction of scar mobility with respect to the underlying tissue of the point of worst adhesion when stretched in four orthogonal directions. It is an economical and easy-to-use instrument with an ergonomic shape, consisting of 9 concentric rings with radii of 1, 2, 4, 6, 8, 10, 12, 14 and 15 mm, respectively, printed on flexible transparency film for photocopiers. (manufacturer part number PP2500 - 3MTM, St. Paul, MN, USA) to ensure maximum adaptability to different anatomical surfaces.
- Foot posture index (FPI):The foot posture index (FPI) is a reliable instrument for this purpose, assuming a diagnostic tool whose purpose is to quantify the degree of neutral, pronated or supinated position of the foot. The following FPI cut-off points are used, which define the foot type category: a) very supinated from -12 to -4, b) supinated from -3 to 0, c) neutral from 1 to 6, d) pronated from 6 to 10 and e) very pronated from 11 to 12.
- Conditions
- Cesarean Scar, Elastography
- Being tested
- negative pulsed pressure AeroFlow system
- Keywords
- elastography, cesarean, adherences, negative pulsed pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
negative pulsed pressure AeroFlow systemDevice
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
- Static cup: preparation: Prepare the tissue surrounding the scar. 5min
- 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.
| Study group | Role | What they receive |
|---|---|---|
| NEGATIVE PULSED PRESSURE INTERVENTION GROUP | Experimental | The number of treatment sessions will consist of a total of 6 sessions, so there will be two sessions over 3 weeks. The evaluations of the participants will be carried out before and after the first session, after the last session of the treatment program received, 15 days and one month after finishing the treatment. Receives: Device: negative pulsed pressure AeroFlow system |
What is being measured
The primary outcome is the main question the study is designed to answer.
elastography measurement
The elastography is obtained when the anatomic image on grayscale ultrasound overlaps parametric color image that expresses the rate of deformity of the tissues, soft tissues tend to develop greater deformity and tissue deformity have lower rigidity.
Measured: Time0 (T0) FIRST DAY BEFORE FIRST TREATMENT, TIME 1 (T1) FIRST DAY AFTER FIRST TREATMENT, TIME 2 (T2) AFTER 6 DAY OF TREATMENT (THE THIRD WEEK) , TIME 3(T3) 15 DAYS AFTER THE SIXTH TREATMENT, TIME 4 (T4) ONE MONTH AFTER THE SIXTH TREATMENT.
Secondary outcomes (2)
adheremeter measurement
Adheremeter is a new device designed to measure postsurgical scar adhesion which is defined as the restriction of scar mobility with respect to the underlying tissue of the point of worst adhesion when stretched in four orthogonal directions. It is an economical and easy-to-use instrument with an ergonomic shape, consisting of 9 concentric rings with radii of 1, 2, 4, 6, 8, 10, 12, 14 and 15 mm, respectively, printed on flexible transparency film for photocopiers. (manufacturer part number PP2500 - 3MTM, St. Paul, MN, USA) to ensure maximum adaptability to different anatomical surfaces.
Measured: Time0 (T0) FIRST DAY BEFORE FIRST TREATMENT, TIME 1 (T1) FIRST DAY AFTER FIRST TREATMENT, TIME 2 (T2) AFTER 6 DAY OF TREATMENT (THE THIRD WEEK) , TIME 3(T3) 15 DAYS AFTER THE SIXTH TREATMENT, TIME 4 (T4) ONE MONTH AFTER THE SIXTH TREATMENT.
Foot posture index
The foot posture index (FPI) is a reliable instrument for this purpose, assuming a diagnostic tool whose purpose is to quantify the degree of neutral, pronated or supinated position of the foot. The following FPI cut-off points are used, which define the foot type category: a) very supinated from -12 to -4, b) supinated from -3 to 0, c) neutral from 1 to 6, d) pronated from 6 to 10 and e) very pronated from 11 to 12.
Measured: Time0 (T0) FIRST DAY BEFORE FIRST TREATMENT, TIME 1 (T1) FIRST DAY AFTER FIRST TREATMENT, TIME 2 (T2) AFTER 6 DAY OF TREATMENT (THE THIRD WEEK) , TIME 3(T3) 15 DAYS AFTER THE SIXTH TREATMENT, TIME 4 (T4) ONE MONTH AFTER THE SIXTH TREATMENT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start30 Oct 2023 (estimated)
- Primary completion11 Feb 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean ScarStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GONZÁLEZ-MUÑOZ, ANA, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057792
- Sponsor's protocol ID
- CLINICAANAGONZALEZ
- Acronym
- ELASTICFLOOR
- Status last verified
- Oct 2023
- First submitted
- 12 Sep 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elastography Changes in Cesarean Scar After Negative Pulsed Pressure Treatment
- ClinicalTrials.gov ID
- NCT06057792
- Acronym / sponsor ID
- ELASTICFLOOR / CLINICAANAGONZALEZ
- Conditions
- Cesarean Scar, Elastography
- Keywords
- elastography, cesarean, adherences, negative pulsed pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 30 Oct 2023 (estimated)
- Primary completion
- 11 Feb 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 28 Sep 2023 (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.
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.
Detailed description
Participants will be recruited at the "Clínica Ana González" physiotherapy clinic. Once recruited, the physiotherapist Ana González Muñoz will carry out the assessment to determine the degree of eligibility of said participants and their inclusion or not in the study. The present study is designed as an open, controlled clinical trial. Two evaluations will be carried out on each participant before and after treatment. Participants who meet the required inclusion/exclusion criteria determined below will be included.
Participants will receive a Negative Pulsed Pressure treatment program with the AeroFlow® equipment. The measuring instruments to be used will be:
- Ultrasound machine.
Description of the ultrasound evaluation
Ultrasound evaluations will be performed. The participant will remain in all measurements. All measurements will be performed with a General Electric S7 R3 The evaluation of tissue quality will be carried out by pixel quantification, using the computer software included in the ultrasound equipment itself.
- Adheremeter Adheremeter is a new device designed to measure postsurgical scar adhesion which is defined as the restriction of scar mobility with respect to the underlying tissue of the point of worst adhesion when stretched in four orthogonal directions. It is an economical and easy-to-use instrument with an ergonomic shape, consisting of 9 concentric rings with radii of 1, 2, 4, 6, 8, 10, 12, 14 and 15 mm, respectively, printed on flexible transparency film for photocopiers. (manufacturer part number PP2500 - 3MTM, St. Paul, MN, USA) to ensure maximum adaptability to different anatomical surfaces.
- Foot posture index (FPI):The foot posture index (FPI) is a reliable instrument for this purpose, assuming a diagnostic tool whose purpose is to quantify the degree of neutral, pronated or supinated position of the foot. The following FPI cut-off points are used, which define the foot type category: a) very supinated from -12 to -4, b) supinated from -3 to 0, c) neutral from 1 to 6, d) pronated from 6 to 10 and e) very pronated from 11 to 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NEGATIVE PULSED PRESSURE INTERVENTION GROUP | Experimental | Device: negative pulsed pressure AeroFlow systemThe number of treatment sessions will consist of a total of 6 sessions, so there will be two sessions over 3 weeks. The evaluations of the participants will be carried out before and after the first session, after the last session of the treatment program received, 15 days and one month after finishing the treatment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants aged between 18 and 60 years
- Who have undergone cesarean section surgery and therefore have a scar, lasting more than six months and less than 2 years.
- Patients who present a post-cesarean section scar with a fibrotic appearance and possible surrounding fascial restrictions.
Key exclusion criteria (4 listed)
- Patients who present any neurological, inflammatory or orthopedic injury that prevents or alters balance, listening, vision or the cognitive abilities necessary to be able to answer appropriate questions or take questionnaires.
- Patients who present keloids in the scar.
- Patients who have contraindications to be treated with a 448kHz radiofrequency device such as:
- to. pregnant women b. Subjects with any type of electronic implants. c. Subjects presenting with thrombophlebitis
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 |
|---|---|---|
| negative pulsed pressure AeroFlow systemFor 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. | Device | NEGATIVE PULSED PRESSURE INTERVENTION GROUP |
Primary outcome
elastography measurement
Time frame: Time0 (T0) FIRST DAY BEFORE FIRST TREATMENT, TIME 1 (T1) FIRST DAY AFTER FIRST TREATMENT, TIME 2 (T2) AFTER 6 DAY OF TREATMENT (THE THIRD WEEK) , TIME 3(T3) 15 DAYS AFTER THE SIXTH TREATMENT, TIME 4 (T4) ONE MONTH AFTER THE SIXTH TREATMENT.
The elastography is obtained when the anatomic image on grayscale ultrasound overlaps parametric color image that expresses the rate of deformity of the tissues, soft tissues tend to develop greater deformity and tissue deformity have lower rigidity.
2 secondary outcomes
adheremeter measurement
Time frame: Time0 (T0) FIRST DAY BEFORE FIRST TREATMENT, TIME 1 (T1) FIRST DAY AFTER FIRST TREATMENT, TIME 2 (T2) AFTER 6 DAY OF TREATMENT (THE THIRD WEEK) , TIME 3(T3) 15 DAYS AFTER THE SIXTH TREATMENT, TIME 4 (T4) ONE MONTH AFTER THE SIXTH TREATMENT.
Foot posture index
Time frame: Time0 (T0) FIRST DAY BEFORE FIRST TREATMENT, TIME 1 (T1) FIRST DAY AFTER FIRST TREATMENT, TIME 2 (T2) AFTER 6 DAY OF TREATMENT (THE THIRD WEEK) , TIME 3(T3) 15 DAYS AFTER THE SIXTH TREATMENT, TIME 4 (T4) ONE MONTH AFTER THE SIXTH TREATMENT.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing negative pulsed pressure AeroFlow system in people with Cesarean Scar and Elastography, run by Universidad de Granada at 2 sites in Spain.
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 3 inclusion and 4 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 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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. 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 ANA GONZÁLEZ (661236109, ANAGONZALEZ.FISIOTERAPEUTA@GMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
elastography measurement (time frame: Time0 (T0) FIRST DAY BEFORE FIRST TREATMENT, TIME 1 (T1) FIRST DAY AFTER FIRST TREATMENT, TIME 2 (T2) AFTER 6 DAY OF TREATMENT (THE THIRD WEEK) , TIME 3(T3) 15 DAYS AFTER THE SIXTH TREATMENT, TIME 4 (T4) ONE MONTH AFTER THE SIXTH TREATMENT.). 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 25 Oct 2023.