Goode 1979.
Methods | RCT Setting: hospital and outpatients, UK | |
Participants | n = 20
(A) 10
(B) 10
13 men/7 women
Age: 24 to 91 years Post surgical wounds, infected wounds left open for delayed closure, or closed wounds requiring opening and drainage following infection Inclusion criteria: patients at risk from wound infection, following abdominal surgery for appendicitis or bowel surgery; wounds heavily contaminated at surgery and left open for delayed primary closure; wounds closed at surgery but developed an abscess and required removal of sutures and wound drainage Exclusion criteria: none listed |
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Interventions | All patients were given antibiotic cover prior to surgery for 48 to 72 hours postoperatively Each wound was photographed at the start, during and at the end of the trial (A) Twice daily dressings of dextranomer granules covered with a light pack (B) Twice daily dressings of Eusol and paraffin‐soaked ribbon gauze All other wound procedures were identical for both groups Independent assessor decided when the wound was clean and could be closed by secondary suture |
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Outcomes | Primary outcomes:
(1) Mean time to wound closure (SD not reported):
(A) 8.1 days
(B)11.6 days
Statistical difference P < 0.05 (Mann‐Whitney U‐test) (2) Time to complete healing not reported Secondary outcomes: (1) Patient satisfaction: not reported (2) Rate of infection: not reported (3) Quality of life: not reported (4) Length of hospital stay (median): (A) 2.2 days less than group B (B) Not reported (5) Cost‐effectiveness: (A) Approximately £3.40 per day (B) Not reported (6) Adverse events: not reported |
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Notes | Trial did report that 1 patient in each group was left to heal by granulation but the time to healing was not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "...each patient was allocated to treatment with either Debrisan or Eusol by means of cards drawn from a sealed envelope" (p325). However, the method used for generating the randomisation sequence for the cards was not reported. Hence, it was judged to be unclear. |
Allocation concealment (selection bias) | Unclear risk | Although "sealed envelopes" are documented no further details are given. |
Blinding (performance bias and detection bias) Participants and personnel | Unclear risk | Participants ‐ blinding not stated but lack of blinding unlikely to influence results Personnel ‐ blinding not stated but unlikely to be achievable due to different properties (beads versus ribbon gauze). Lack of blinding unlikely to influence results. |
Blinding (performance bias and detection bias) Outcome assessors | Low risk | Outcome assessor ‐ blinded to treatment "an independent assessor decided when the wound was clean" using photographs of the wound (p325) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 20 patients studied, 20 patients "mean time to secondary wound closure reported" reported within table 1 (p325). One patient in each treatment group did not achieve wound secondary wound closure. |
Selective reporting (reporting bias) | Low risk | No study protocol available but expected outcomes reported "Efficacy of treatment assessed by time taken to allow secondary skin closure, by the condition of the wound after closure and the number of days in hospital" (p328) all reported on although limited details given for the later 2 |