| Methods |
This was a 2‐arm, parallel group RCT lasting 24 weeks |
| Participants |
The trial included 31 HS participants who had not responded to antibiotics and local surgery. The paper did not state the number of participants randomised to each intervention |
| Interventions |
2 groups, randomised in a 1:1 ratio:
vehicle placebo (broth in which the intervention was carried): placebo 0.6 ml as an aerosol and 0.3 ml s/c, once weekly for 20 weeks ‐ 15 participants reached the end of the study staphage lysate 0.6 ml as an aerosol and 0.3 ml staphage lysate s/c, once weekly for 20 weeks ‐ 12 participants reached the end of the study
|
| Outcomes |
Physician Global Assessment, graded as improved, same, or worse at 24 weeks Adverse effects briefly reported in narrative form |
| Notes |
Staphage lysate was obtained by lysis of broth cultures of 2 strains of S. aureus using the Gratia bacteriophage, followed by ultrafiltration. The method of action was thought to be the induction of delayed type hypersensitivity. There was no declaration regarding trial sponsorship or funding source. There were several gaps in the reporting of the study; we were unable to contact the authors for clarification |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
The paper did not state a method of random sequence generation |
| Allocation concealment (selection bias) |
Unclear risk |
The paper provided no details |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Placebos were used for both the aerosol and s/c injections consisting of the broth in which the intervention was carried, and no significant adverse effects were reported |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
The placebos were effective, and the paper reported no significant adverse effects |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
The paper gave no reasons for study withdrawals, but only 4/31 participants withdrew (13%) |
| Selective reporting (reporting bias) |
Unclear risk |
There was no reference to prospective trial registration. (The study was performed before this was common) |
| Other bias |
Unclear risk |
The paper did not declare a funding source |
