Capsular Contracture, ImplantNCT03171974
Ultrasound Guided Treatment of Steroids for Capsular Contracture in Patients With Reconstructed/Augmented Breast
A study testing Dexamethasone and US in people with Capsular Contracture, Implant, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Ultrasound guided treatment of steroids for capsular contracture in patients with reconstructed/augmented breast Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Capsular Contracture, Implant
- What is being tested?
- Dexamethasone and US
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Oct 2017to Dec 2019
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- female patient with grade 3-4 capsular contraction after alloplastic breast reconstruction\ augmentation
Who cannot join
- intake of steroids, anti-inflammatory, anti-coagulate or immunomodulatory medications on a regular basis
- Patients with skin atrophy of the breast
Trial locations and contacts
1 site in 1 country.
omri dominsky, MD contact
About this study
Ultrasound guided treatment of steroids for capsular contracture in patients with reconstructed/augmented breast
Read the detailed description
The aim of this study is to evaluate ultrasound (US)-guided treatment of capsular contracture (CC) in patients with reconstructed/ augmented breast.
Capsular contraction is the one of the most common complications of both esthetic and reconstructive breast surgery with an incidence of 0.5-30% and 1-38%, respectively. In irradiated patients the incidence is higher, in the range of 30-67%. It appears most commonly in the first year but in some patients, belated capsular contracture has been noticed. The more severe forms of contraction, Baker grades 3 and 4 with a firm often deformed and painful breast, have been shown to recur as often as 67% after capsulotomy
steroid injection has been demonstrated to be effective for the treatment of this condition.
20-30 female with grade III\IV CC will be included. Patients will be treated with peri-implant US-guided injection of Dexamethasone
The purpose of our study is to use a longer acting steroid (Dexamethasone) injected intra capsular with US-guide. By that getting a better effect on the level of fibrosis.
This Clinical study will be conducted in the tertiary academic Rabin Medical Center.
Several measures will be taken, including: capsular contracture grading by two plastic surgeons, a VAS-score of breast pain, maximal capsular thickness (MCT) in sonography
- Conditions
- Capsular Contracture, Implant
- Being tested
- Dexamethasone, US
- Keywords
- breast capsular contructure
- Medical subject headings
- Implant Capsular Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
dexamethasone will be injected intracapsular under US
USDevice
dexamethasone will be injected intracapsular under US
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | The treatment group will be injected with dexamethasone instracapsular under US according to our built protocol. Receives: Drug: Dexamethasone; Device: US |
What is being measured
The primary outcome is the main question the study is designed to answer.
reducing maximum capsular thickness (MCT)
measured by ultrasound
Measured: 3.5 years
reduce pain
pain assessed with visual analogue score (pain-VAS).
Measured: 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start1 Oct 2017 (estimated)
- Primary completionAug 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Capsular Contracture, ImplantStudies 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
- Model description
- one treatment group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhamad Mansur, Rabin Medical Center
- Investigators
- Muhammad Mansour, MD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171974
- Sponsor's protocol ID
- 0213-17-RMC
- Status last verified
- Sep 2017
- First submitted
- 24 May 2017
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Treatment of Steroids for Capsular Contracture in Patients With Reconstructed/Augmented Breast
- ClinicalTrials.gov ID
- NCT03171974
- Acronym / sponsor ID
- 0213-17-RMC
- Conditions
- Capsular Contracture, Implant
- Keywords
- breast capsular contructure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 31 May 2017 (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.
Ultrasound guided treatment of steroids for capsular contracture in patients with reconstructed/augmented breast
Detailed description
The aim of this study is to evaluate ultrasound (US)-guided treatment of capsular contracture (CC) in patients with reconstructed/ augmented breast.
Capsular contraction is the one of the most common complications of both esthetic and reconstructive breast surgery with an incidence of 0.5-30% and 1-38%, respectively. In irradiated patients the incidence is higher, in the range of 30-67%. It appears most commonly in the first year but in some patients, belated capsular contracture has been noticed. The more severe forms of contraction, Baker grades 3 and 4 with a firm often deformed and painful breast, have been shown to recur as often as 67% after capsulotomy
steroid injection has been demonstrated to be effective for the treatment of this condition.
20-30 female with grade III\IV CC will be included. Patients will be treated with peri-implant US-guided injection of Dexamethasone
The purpose of our study is to use a longer acting steroid (Dexamethasone) injected intra capsular with US-guide. By that getting a better effect on the level of fibrosis.
This Clinical study will be conducted in the tertiary academic Rabin Medical Center.
Several measures will be taken, including: capsular contracture grading by two plastic surgeons, a VAS-score of breast pain, maximal capsular thickness (MCT) in sonography
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- one treatment group
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: Dexamethasone, Device: USThe treatment group will be injected with dexamethasone instracapsular under US according to our built protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- female patient with grade 3-4 capsular contraction after alloplastic breast reconstruction\ augmentation
Key exclusion criteria (2 listed)
- intake of steroids, anti-inflammatory, anti-coagulate or immunomodulatory medications on a regular basis
- Patients with skin atrophy of the breast
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 |
|---|---|---|
| Dexamethasonedexamethasone will be injected intracapsular under US | Drug | treatment group |
| USdexamethasone will be injected intracapsular under US | Device | treatment group |
Primary outcome
reducing maximum capsular thickness (MCT)
Time frame: 3.5 years
measured by ultrasound
reduce pain
Time frame: 3.5 years
pain assessed with visual analogue score (pain-VAS).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
- Individual participant dataSharing planned: Yes
Related trials for Capsular Contracture, Implant
Active, not recruitingPhase 3
Local Antibiotics for Breast Implants
Implant Complication, Implant Infection
Recruiting
Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation
Capsular Contracture Associated With Breast Implant, Capsular Contracture Grade III
RecruitingObservational study
Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Clinically Significant Capsular Contracture
Capsular Contracture of Breast Implant
Recruiting
Predictive Toxicity Test Linked to Radiotherapy After Mastectomy and Immediate Implant Reconstruction
Breast Cancer, Capsular Contracture Associated With Breast Implant
Enrolling by invitation
Pseudomonas Aeruginosa Injection Combined With Polyvinylpyrrolidone-Iodine in Immediate Breast Reconstruction Surgery With Implants
Postoperative Seroma Rate, Drainage Tube Removal Time, and Capsular Contracture Rate, Seroma Following Procedure
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.
omri dominsky, MD contact
Muhammad Mansour, MD principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone and US in people with Capsular Contracture, Implant, run by Rabin Medical Center at 1 site in Israel.
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 1 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 3 Oct 2017. 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 Israel. 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 Muhammad Mansour, MD (972545717393, Muhammad.dima@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reducing maximum capsular thickness (MCT) (time frame: 3.5 years). The study lists 2 primary outcomes in all. 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 3 Oct 2017.