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. 2019 May 31;2019(5):CD004680. doi: 10.1002/14651858.CD004680.pub3

SIPROCE 1997.

Methods

  • Study design: parallel RCT

  • Study time frame/recruitment period: October 1994 to April 1996

  • Follow‐up period: cumulative time of observation in the silver ring group was 857 months compared with 937 months in the control group
Participants

  • Country: Germany

  • Setting: multicentre (7 sites)

  • All patients undergoing PD treatment

  • Number: treatment group (97); control group (98)

  • Mean age ± SD (years): treatment group (44.74 ± 17.6); control group (47.01 ± 18.5)

  • Sex (M/F): treatment group (63/34); control group (52/46)

  • Diabetic: treatment group (19/97); control group (21/98)

  • Exclusion criteria: acute or chronic exit‐site infections; sinus tract/tunnel infections; peritonitis during the ascertainment period (October 1994 to April 1995)
Interventions Treatment group

  • Silver ring

  • The silver ring was placed at the skin level of the exit site and, if necessary, fixed by a silicone ring with silicone glue to avoid displacement above or below the skin level.


Control group

  • No silver ring
Outcomes

  • First occurrence of exit‐site infection: exit‐site infection was defined as reddening with purulent discharge from the exit site (grade II of the visual classification scale) and/or a significantly increased sulcus fluid flow rate (SFFR) measurement in relation to the visual appearance of the exit site

  • First occurrence of peritonitis

  • Death (all causes)

  • Catheter removal/replacement

  • Technique failure
Notes

  • Funding source: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to permit judgement
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Not blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes High risk High dropout 30% (59/195)
Selective reporting (reporting bias) Low risk Most of the outcomes were reported
Other bias Unclear risk Insufficient information to permit judgement