| Methods |
Study design: parallel RCT Study time frame/recruitment period: March 1990 ‐ March 1991 Follow‐up period: 60 weeks |
| Participants |
Country: UK Setting: single centre All patients who had a Tenckhoff catheter inserted Number: treatment group 1 (22); treatment group 2 (23); control group (21) Mean age ± SD (years): treatment group 1 (45 ± 15.51); treatment group 2 (40 ± 14.26); control group (43 ± 15.8) Sex (M/F): not reported Diabetes: treatment group 1 (4/22); treatment group 2 (5/23); control group (4/21) Exclusion criteria: not reported |
| Interventions |
Treatment group 1
Immobilisation via device Immediately upon insertion of catheter the immobilisation device was placed over the catheter 1‐3 inches from the exit site by the surgeon. It was kept in place at all times and replaced daily after showering. A new immobiliser was positioned before removal of the old one
Treatment group 2
Control group
|
| Outcomes |
Exit‐site/tunnel infection: defined as clinically apparent infection (purulent drainage, redness, swelling, warmth and tenderness) at the exit site with/without a positive culture Exit‐site/tunnel infection rate Peritonitis |
| Notes |
|
| 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 |
Unclear risk |
Insufficient information to permit judgement |
| Selective reporting (reporting bias) |
High risk |
Not all the outcomes were reported |
| Other bias |
Unclear risk |
Insufficient information to permit judgement |
