NCT03742908

Brief Summary

The study aims to investigate different approaches of local application of antibiotics/antiseptics intraoperatively in Chinese patients undergoing post-mastectomy implant based breast reconstruction, and aims to single out an intervention method that limits the use of antibiotics and maintains low rates of surgical site infection and capsular contracture. Patients who undergo post mastectomy breast reconstruction in the breast reconstruction department in Tianjin Medical University Cancer Institute and Hospital are eligible to enter the study.

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
291

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 16, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 15, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

November 15, 2018

Status Verified

November 1, 2018

Enrollment Period

3.4 years

First QC Date

November 7, 2018

Last Update Submit

November 14, 2018

Conditions

Breast Neoplasms

Keywords

Implant-based breast reconstructionintraoperative antibiotics/antisepticsChinese

Outcome Measures

Primary Outcomes (3)

  • Occurrence of minor surgical site infection

    the reconstructed breasts present with redness, edema, pain and rise in skin temperature by observation, drainage or wound secretion microbiology culture are positive, the symptoms are relieved by oral antibiotics.

    assessed up to 3 months post-op

  • Occurrence of major surgical site infection

    the reconstructed breasts present with redness, edema, pain and rise in skin temperature by observation, drainage or wound secretion microbiology culture are positive, the symptoms are relieved by intravenous antibiotics or demand surgical interventions such as explantation or change of implant.

    assessed up to 3 months post-op

  • Occurrence of capsular contracture

    Hardness, pain, and or changes of shape/volume of the reconstructed breasts both by observation or inspected by breast imaging .The grade of capsular contracture is recorded in baker's grading(I-IV).

    assessed from 3 months post-op up to 2 years post-op or until the trial ends, whichever comes first

Secondary Outcomes (4)

  • Occurrence of flap necrosis

    assessed up to 1 months post-op

  • Occurrence of hematoma

    assessed up to 72 hours post-op

  • Occurrence of peri-prosthetic seroma

    from 3 months post-op up to 2 years post-op or until the trial ends

  • Baseline and changes of patient's evaluation

    evaluate at 6 months as baseline, repeated evaluation at 12 months and 24 months post-op or until the trial ends, whichever comes first, to record changes

Study Arms (3)

saline control

NO INTERVENTION

Implant immersion with 100 ml sterile saline (0.9%) for 10 minutes; Breast pocket irrigation (IRRI) with 100ml type III Anerdian for 30 seconds and washed with a total of 1000ml sterile distilled water twice afterwards. No antibiotics is used.

Cefazolin/clindamycin immersion

EXPERIMENTAL

Implant immersion: implant is immersed with 200mg cefazolin in 100 ml sterile saline (0.9%) for 10 minutes, if the patient is allergic to cefazolin, 600mg clindamycin in 100ml sterile saline (0.9%) is used instead for immersion; Breast pocket irrigation (IRRI) with100ml type III Anerdian for 30 seconds and washed with a total of 1000ml sterile distilled water twice afterwards

Drug: Cefazolin/clindamycin

Cefazolin/clindamycin immersion+ IRRI

EXPERIMENTAL

Implant immersion: implant is immersed with 200mg cefazolin in 100 ml sterile saline (0.9%) for 10 minutes, if the patient is allergic to cefazolin, 600mg clindamycin in 100ml sterile saline (0.9%) is used instead for immersion; Breast pocket irrigation (IRRI): breast pocket is irrigated with100ml type III Anerdian plus 200mg cefazolin in 100 ml sterile saline (0.9%) for 30 seconds and washed with a total of 1000ml sterile distilled water twice afterwards, if the patient is allergic to cefazolin, 600mg clindamycin in 100ml sterile saline (0.9%) is used instead of cefazolin

Drug: Cefazolin/clindamycin

Interventions

Cefazolin/clindamycinDRUG

Local implant immersion and/or breast pocket irrigation

Also known as: Ancef, Kefzol, Cleocin
Cefazolin/clindamycin immersionCefazolin/clindamycin immersion+ IRRI

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients with natural breasts
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who underwent mastectomy and eligible for implant-based breast reconstructions
  • Karnofsky Performance Status (KPS) larger than 70
  • No severe deficiency in hematological, cardiovascular system, no immunodeficiency, no severe abnormal liver or kidney function

You may not qualify if:

  • Metastatic breast cancer
  • Local or systemic infection within 30 days prior to breast reconstruction surgery
  • Local, oral or systemic administration of any form of antibiotics within 30 days prior to breast reconstruction surgery
  • Pre-operative complete blood count shows white blood cell (WBC) count \>10\*10\^9/L, Neutrophil cell (N) count \> 7.5\*10\^9/L or N%\>80%
  • Pre-operative blood procalcitonin (PCT) higher than upper limit of the normal range
  • Past history with injection breast augmentation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Related Publications (12)

  • Kummerow KL, Du L, Penson DF, Shyr Y, Hooks MA. Nationwide trends in mastectomy for early-stage breast cancer. JAMA Surg. 2015 Jan;150(1):9-16. doi: 10.1001/jamasurg.2014.2895.

    PMID: 25408966BACKGROUND

  • Piper ML, Roussel LO, Koltz PF, Wang F, Singh K, Chin R, Sbitany H, Langstein HN. Characterizing infections in prosthetic breast reconstruction: A validity assessment of national health databases. J Plast Reconstr Aesthet Surg. 2017 Oct;70(10):1345-1353. doi: 10.1016/j.bjps.2017.05.004. Epub 2017 May 18.

    PMID: 28619483BACKGROUND

  • Constantine RS, Constantine FC, Rohrich RJ. The ever-changing role of biofilms in plastic surgery. Plast Reconstr Surg. 2014 Jun;133(6):865e-872e. doi: 10.1097/PRS.0000000000000213.

    PMID: 24867746BACKGROUND

  • Rubino C, Brongo S, Pagliara D, Cuomo R, Abbinante G, Campitiello N, Santanelli F, Chessa D. Infections in breast implants: a review with a focus on developing countries. J Infect Dev Ctries. 2014 Sep 12;8(9):1089-95. doi: 10.3855/jidc.3898.

    PMID: 25212072BACKGROUND

  • Reish RG, Damjanovic B, Austen WG Jr, Winograd J, Liao EC, Cetrulo CL, Balkin DM, Colwell AS. Infection following implant-based reconstruction in 1952 consecutive breast reconstructions: salvage rates and predictors of success. Plast Reconstr Surg. 2013 Jun;131(6):1223-1230. doi: 10.1097/PRS.0b013e31828bd377.

    PMID: 23714788BACKGROUND

  • Alderman A, Gutowski K, Ahuja A, Gray D; Postmastectomy ExpanderImplant Breast Reconstruction Guideline Work Group. ASPS clinical practice guideline summary on breast reconstruction with expanders and implants. Plast Reconstr Surg. 2014 Oct;134(4):648e-655e. doi: 10.1097/PRS.0000000000000541.

    PMID: 25357060BACKGROUND

  • Barr SP, Topps AR, Barnes NL, Henderson J, Hignett S, Teasdale RL, McKenna A, Harvey JR, Kirwan CC; Northwest Breast Surgical Research Collaborative. Infection prevention in breast implant surgery - A review of the surgical evidence, guidelines and a checklist. Eur J Surg Oncol. 2016 May;42(5):591-603. doi: 10.1016/j.ejso.2016.02.240. Epub 2016 Feb 27.

    PMID: 27005885BACKGROUND

  • Phillips BT, Fourman MS, Bishawi M, Zegers M, O'Hea BJ, Ganz JC, Huston TL, Dagum AB, Khan SU, Bui DT. Are Prophylactic Postoperative Antibiotics Necessary for Immediate Breast Reconstruction? Results of a Prospective Randomized Clinical Trial. J Am Coll Surg. 2016 Jun;222(6):1116-24. doi: 10.1016/j.jamcollsurg.2016.02.018. Epub 2016 Mar 4.

    PMID: 27106640BACKGROUND

  • Phillips BT, Halvorson EG. Antibiotic Prophylaxis following Implant-Based Breast Reconstruction: What Is the Evidence? Plast Reconstr Surg. 2016 Oct;138(4):751-757. doi: 10.1097/PRS.0000000000002530.

    PMID: 27307337BACKGROUND

  • Huang N, Liu M, Yu P, Wu J. Antibiotic prophylaxis in prosthesis-based mammoplasty: a systematic review. Int J Surg. 2015 Mar;15:31-7. doi: 10.1016/j.ijsu.2015.01.020. Epub 2015 Jan 29.

    PMID: 25638736BACKGROUND

  • Gowda AU, Chopra K, Brown EN, Slezak S, Rasko Y. Preventing Breast Implant Contamination in Breast Reconstruction: A National Survey of Current Practice. Ann Plast Surg. 2017 Feb;78(2):153-156. doi: 10.1097/SAP.0000000000000822.

    PMID: 27464530BACKGROUND

  • Frois AO, Harbour PO, Azimi F, Young J, Chan B, Mak C, Warrier S. The Role of Antibiotics in Breast Pocket Irrigation and Implant Immersion: A Systematic Review. Plast Reconstr Surg Glob Open. 2018 Sep 14;6(9):e1868. doi: 10.1097/GOX.0000000000001868. eCollection 2018 Sep.

    PMID: 30349776BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CefazolinClindamycin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLincomycinLincosamidesPyrrolidinesHeterocyclic Compounds, 1-RingGlycosidesCarbohydrates

Study Officials

  • Jian Yin

    Tianjin Medical University Cancer Institute and Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shanshan He

CONTACT

+86-22-23340123ssh85@yahoo.com

Jian Yin

CONTACT

+86-22-23340123yinjian@tjmuch.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Treatment allocation is revealed to the surgical team intraoperatively. Treatment allocation is revealed to the patient post-op in their first followup visit in the clinics.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Block randomization is generated by one investigator that is not involved in surgery and the block size is kept hidden from other investigators and patients.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2018

First Posted

November 15, 2018

Study Start

June 16, 2018

Primary Completion

October 31, 2021

Study Completion

October 31, 2021

Last Updated

November 15, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data (IPD) available to other researchers

Locations

CN(1)