Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Clinically Significant Capsular Contracture
2. september 2026 opdateret af: Research Inc
This prospective breast implant surveillance cohort will evaluate whether implant age, pocket plane, incision route, surface texture, and volume predict clinically significant capsular contracture.
Women with Baker grade I or II aesthetic implants at enrollment will undergo standardized annual assessments for up to five years.
The primary outcome is time to incident Baker grade III or IV contracture.
Progression, pain, imaging, treatment, and patient-reported outcomes will also be described.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Women with aesthetic breast implants and no clinically significant contracture at cohort entry will be enrolled into a dynamic surveillance cohort.
Operative and device information will be verified from records.
Trained assessors will apply a locked Baker grading protocol annually, supported by photographs, symptom assessment, and imaging.
Suspected incident Baker III/IV contracture will undergo independent confirmation and operative verification when available.
Delayed-entry survival models will estimate the independent effects of implant age, plane, incision, texture, and volume while accounting for bilateral implants and competing implant removal.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
3000
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Juan Velez, MD, Plastic surgeon
- Telefonnummer: +57 3054511588
- E-mail: info@velezlara.com
Studiesteder
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Medellín, Colombia
- Rekruttering
- IQ interquirofanos
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Kontakt:
- juan Velez, MD, Plastic surgeon
- Telefonnummer: +573054511588
- E-mail: direccion.medica@iqinterquirofanos.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Adult women with aesthetic breast implants and no clinically significant capsular contracture at cohort entry.
Beskrivelse
Inclusion Criteria:
- Female sex and age 18 years or older.
- Aesthetic breast augmentation with permanent silicone or saline implants under the final protocol.
- Baker grade I or II in the analyzed breast at cohort entry, confirmed by standardized examination.
- Known implantation date or year and known pocket plane, incision route, surface texture, and volume.
- Ability to complete annual clinical assessment for up to five years.
- Written informed consent.
Exclusion Criteria:
- Baker grade III or IV contracture at cohort entry in the analyzed breast.
- Reconstructive implantation after mastectomy or major trauma.
- Tissue expander.
- Active breast infection or open wound at enrollment.
- Planned immediate implant exchange or explantation.
- Missing core implant or operative data.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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Breast Implant Capsule Surveillance Cohort
Women with Baker grade I or II implants are followed prospectively.
Implant and operative characteristics are modeled as exposures.
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Implant-level data include age, laterality, material, surface texture, shape, volume, pocket plane, incision route, primary or revision placement, manufacturer/lot when available, and concomitant mastopexy or fat grafting.
Linked arm/group(s): Breast Implant Capsule Surveillance Cohort.
Two trained assessors will apply a standardized Baker grading protocol, with breast firmness, distortion, pain, and imaging recorded.
Suspected grade III/IV events will undergo central review or operative confirmation when surgery occurs.
Linked arm/group(s): Breast Implant Capsule Surveillance Cohort.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Time to Incident Baker Grade III or IV Capsular Contracture
Tidsramme: From cohort entry through years of prospective follow-up. 10 years
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Implant-level time from cohort entry to the first confirmed clinically significant contracture.
Grade III is visible distortion/firmness and grade IV includes pain under the locked examination manual.
Bilateral implants will be clustered by participant.
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From cohort entry through years of prospective follow-up. 10 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Capsular Contracture-Free Survival by Implant Age
Tidsramme: Prospective follow-up through 10 years
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Probability of remaining free of Baker grade III/IV contracture at prespecified implant ages, estimated with delayed-entry survival methods when prevalent implants are included.
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Prospective follow-up through 10 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: juan velez, MD, plastic surgery
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Bachour Y, Bargon CA, de Blok CJM, Ket JCF, Ritt MJPF, Niessen FB. Risk factors for developing capsular contracture in women after breast implant surgery: A systematic review of the literature. J Plast Reconstr Aesthet Surg. 2018 Sep;71(9):e29-e48. doi: 10.1016/j.bjps.2018.05.022. Epub 2018 Jun 9.
- Calobrace MB, Stevens WG, Capizzi PJ, Cohen R, Godinez T, Beckstrand M. Risk Factor Analysis for Capsular Contracture: A 10-Year Sientra Study Using Round, Smooth, and Textured Implants for Breast Augmentation. Plast Reconstr Surg. 2018 Apr;141(4S Sientra Shaped and Round Cohesive Gel Implants):20S-28S. doi: 10.1097/PRS.0000000000004351.
- Christodoulou N, Secanho M, Kokosis G, Malgor RD, Winocour J, Yu JW, Mathes DW, Kaoutzanis C. Capsular contracture in breast reconstruction: A systematic review and meta-analysis. J Plast Reconstr Aesthet Surg. 2024 Nov;98:131-143. doi: 10.1016/j.bjps.2024.08.057. Epub 2024 Aug 17.
- Stevens WG, Nahabedian MY, Calobrace MB, Harrington JL, Capizzi PJ, Cohen R, d'Incelli RC, Beckstrand M. Risk factor analysis for capsular contracture: a 5-year Sientra study analysis using round, smooth, and textured implants for breast augmentation. Plast Reconstr Surg. 2013 Nov;132(5):1115-1123. doi: 10.1097/01.prs.0000435317.76381.68.
- Liu X, Zhou L, Pan F, Gao Y, Yuan X, Fan D. Comparison of the postoperative incidence rate of capsular contracture among different breast implants: a cumulative meta-analysis. PLoS One. 2015 Feb 13;10(2):e0116071. doi: 10.1371/journal.pone.0116071. eCollection 2015.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
12. januar 2014
Primær færdiggørelse (Faktiske)
1. januar 2026
Studieafslutning (Anslået)
15. december 2026
Datoer for studieregistrering
Først indsendt
2. september 2026
Først indsendt, der opfyldte QC-kriterier
2. september 2026
Først opslået (Faktiske)
9. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 021
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
not contempled in the patient informed consent
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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