Eryilmaz 2005.
| Methods |
Study design: prospective RCT. Duration of study: January 2000 to July 2003. |
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| Participants |
Sample size: 45. Inclusion criteria: lactating women with breast abscesses presenting at the surgical clinic. Women were treated for mastitis prior to development of the abscess. Exclusion criteria: not reported. Setting: Department of surgery Vakif Gureba training hospital, Instanbul. Country: Turkey. |
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| Interventions |
1. Incision and drainage (n = 23) The procedure was done via the surgical OPD using local anaesthesia . The abscess was incised and the infected fluid was evacuated. The wound was left open to drain and dressed daily until the wound healed. A sample of the infected fluid was sent for bacteriological examination. Antibiotics were prescribed post‐operatively. Women were encouraged to feed from the unaffected breast and the breast with the abscess was emptied using breast pump. 2. Needle aspiration. Ultrasound guidance was not used (n = 22) It is unclear as to whether any anaesthesia was used during this intervention. Aspirations were repeated on alternate days until the abscess had completely resolved or until 5 needle aspirations had been performed. A sample of the infected fluid was sent for bacteriological examination. Antibiotics were prescribed post‐operatively Breastfeeding as per I&D group. |
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| Outcomes | Primary outcomes and secondary outcomes. Authors did not differentiate between primary and secondary outcomes.
Definition of healing for incision and drainage group: healing was defined as time from incision and drainage to wound closure. Definition of failure for needle aspiration group: if after 5 aspirations which were done every other day the abscess was not resolved, this was considered a failure of treatment. |
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| Notes |
Funding: not reported. Ethics approval: not stated. Informed consent obtained from the participants. Author contacted: yes, no response received. Below are the questions sent to the authors via email.
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Women were randomised 1:1. Method of randomisation not reported. |
| Allocation concealment (selection bias) | Unclear risk | Not described. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Although there was no blinding, it is unclear whether the resolution of the abscess would be affected. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No blinding was done. Blinding of outcome assessors is not possible due to the nature of the interventions and therefore difficult to judge whether this has an impact. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 9 women were excluded from the analysis in the needle aspiration group (mean healing time). The authors have not described how long the abscesses took to heal even after I&D. |
| Selective reporting (reporting bias) | Low risk | All prespecified outcomes were reported on. |
| Other bias | Unclear risk | Funding: authors did not declare any competing interests. Ethics approval: not stated. Informed consent obtained from the participants. Author contacted: yes. |