Clinical trial · Interventional
Application of Intra-operative Prophylactic Antibiotics/Antiseptics in Chinese Breast Reconstruction Patients
A Single Center Prospective Randomized Control Trial Investigating the Short-term and Long-term Effects of Intraoperative Prophylactic Antibiotics/Antiseptics on Surgical Outcomes in Chinese Post-mastectomy Breast Reconstruction Patients
NCT03742908CI-TRIAL-00035804unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cefazolin/clindamycin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- saline control
- description
- 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.
- type
- EXPERIMENTAL
- label
- Cefazolin/clindamycin immersion
- description
- 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
- interventionNames
- Drug: Cefazolin/clindamycin
- type
- EXPERIMENTAL
- label
- Cefazolin/clindamycin immersion+ IRRI
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (12)
- BACKGROUNDKummerow 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 25408966
- BACKGROUNDPiper 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 28619483
- BACKGROUNDConstantine 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 24867746
- BACKGROUNDRubino 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 25212072
- BACKGROUNDReish 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 23714788
- BACKGROUNDAlderman 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 25357060
- BACKGROUNDBarr 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.