Background
Methods
Design
Ethics
Participants
Randomisation, allocation concealment, and blinding
Intervention
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Skin closure: subcuticular closure of the skin with a 3/0 absorbable (Caprosyn™) or non-absorbable (Prolene™) synthetic monofilament suture material
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Fascia closure: closure or non-closure of subcutaneous fascia, performed with 2/0 Vicryl® suture
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Group 1 - non-absorbable skin suture and non-closure of the subcutaneous fascia;
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Group 2 - absorbable skin suture and non-closure of the subcutaneous fascia;
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Group 3 - non-absorbable skin suture and closure of the subcutaneous fascia; and
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Group 4 - absorbable skin suture and closure of the subcutaneous fascia.
Participant follow-up
Outcome
Statistical analysis
Results
Participants
Characteristic | Group 1 Non-absorbable suture and non-closure fascia N = 215 | Group 2 Absorbable suture and non-closure fascia N = 211 | Group 3 Non-absorbable suture and closure fascia N = 212 | Group 4 Absorbable suture and closure fascia N = 211 | Total N = 849 |
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Maternal age (years; mean (SD)) | 31.26 (5.73) | 31.56 (5.32) | 31.16 (5.81) | 31.93 (5.62) | 31.48 (5.62) |
BMI (kg/m2) Median (IQR) | 28.29 (7.37) | 28.84 (7.60) | 28.75 (7.33) | 28.54 (7.18) | 28.60 (7.36) |
BMI category (kg/m2) N (%) | |||||
- BMI ≤ 25.0 | 86 (40.00) | 79 (37.44) | 81 (38.21) | 78 (36.97) | 324 (38.16) |
- BMI >25.0 | 129 (60.00) | 132 (62.56) | 131 (61.79) | 133 (63.03) | 525 (61.84) |
Caesarean section type N (%) | |||||
- elective | 177 (82.33) | 175 (82.94) | 175 (82.55) | 174 (82.46) | 701 (82.57) |
- emergency | 38 (17.67) | 36 (17.06) | 37 (17.45) | 37 (17.54) | 148 (17.43) |
Gestational age at delivery Mean (SD) | 38.34 (2.02) | 38.48 (2.12) | 38.50 (1.85) | 38.70 (1.31) | 38.50 (1.85) |
Ethnicity N(%) | |||||
- Caucasian | 155 (72.09) | 162 (76.78) | 157 (74.06) | 167 (79.15) | 641 (75.50) |
- Other | 60 (27.91) | 49 (23.22) | 55 (25.94) | 44 (20.85) | 208 (24.50) |
Parity N (%) | |||||
- 0 | 48 (22.33) | 49 (23.22) | 53 (25.00) | 43 (20.38) | 193 (22.73) |
- 1 or more | 167 (77.67) | 162 (76.78) | 159 (75.00) | 168 (79.62) | 656 (77.27) |
Smoker N (%) | 40 (18.60) | 41 (19.43) | 42 (19.81) | 34 (16.11) | 157 (18.49) |
Singleton pregnancy N(%): | 207 (96.28) | 202 (95.73) | 206 (97.17) | 202 (95.73) | 817 (96.23) |
Previous Caesarean section N(%) | 146 (67.91) | 136 (64.45) | 136 (64.15) | 144 (68.25) | 562 (66.20) |
Previous non-caesarean laparotomy N(%) | 6 (2.79) | 5 (2.37) | 6 (2.83) | 6 (2.84) | 23 (2.71) |
Wound infection and complication outcomes
Group 1 Non-absorbable suture and non-closure fascia N = 215 | Group 2 Absorbable suture and non-closure fascia N = 211 | Group 3 Non-absorbable suture and closure fascia N = 212 | Group 4 Absorbable suture and closure fascia N = 211 | Total N = 849 | |
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Wound infection N(%) | 17 (7.91) | 17 (8.06) | 10 (4.72) | 22 (10.43) | 66 (7.77) |
Haematoma/Seroma N(%) | 1 (0.47) | 2 (0.95) | 0 (0.00) | 4 (1.90) | 7 (0.82) |
Reoperation N(%) | 0 (0.00) | 1 (0.47) | 0 (0.00) | 4 (1.90) | 5 (0.59) |
Readmission N(%) | 0 (0.00) | 0 (0.00) | 1 (0.47) | 2 (0.95) | 3 (0.35) |
Emergency presentation for wound management N(%) | 14 (6.51) | 8 (3.79) | 9 (4.25) | 17 (8.06) | 48 (5.65) |
Pain score at day 3 Mean (SD) | 2.87 (1.91) | 3.02 (1.99) | 3.09 (2.06) | 2.85 (2.12) |
Effect estimates of different closure techniques
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The effect of absorbable sutures vs non-absorbable skin suture was estimated in participants who had fascia closure, and in participants who did not have fascia closure; and
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The effect of fascia closure was estimated in participants who had absorbable vs non-absorbable skin sutures.
Outcome | Unadjusted Estimate (95% CI) | Unadjusted p value | Adjusted Estimate d (95% CI) | Adjusted p value |
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Wound Infection | 0.117* | 0.119* | ||
Non-absorbable versus absorbable suture with fascia non-closure | 1.02 (0.53, 1.94) | 0.954 | 1.01 (0.53, 1.91) | 0.984 |
Non-absorbable versus absorbable suture with fascia closure | 2.21 (1.07, 4.55) | 0.031 | 2.17 (1.05, 4.45) | 0.035 |
Fascia non-closure versus closure with non-absorbable suture | 0.60 (0.28, 1.27) | 0.181 | 0.59 (0.28, 1.25) | 0.169 |
Fascia non-closure versus closure with absorbable suture | 1.29 (0.71, 2.37) | 0.402 | 1.27 (0.70, 2.31) | 0.437 |
Haematoma/Seromaa | ||||
- Fishers Exact Test | 0.574 | |||
Re-Operationa | ||||
- Fishers Exact Test | 0.013 | |||
Readmissiona | ||||
- Fishers Exact Test | 0.246 | |||
Emergency Presentation | 0.045* | 0.046* | ||
- Absorbable suture and fascia non-closure | 0.58 (0.25, 1.36) | 0.211 | 0.58 (0.25, 1.35) | 0.205 |
- Absorbable suture and fascia closure | 1.90 (0.87, 4.16) | 0.110 | 1.87 (0.85, 4.08) | 0.118 |
- Fascia closure and non-absorbable suture | 0.65 (0.29, 1.47) | 0.304 | 0.64 (0.29, 1.45) | 0.288 |
- Fascia closure and absorbable suture | 2.12 (0.94, 4.82) | 0.071 | 2.07 (0.92, 4.69) | 0.080 |
Day 3 Pain Score | 0.223* | 0.221* | ||
- Absorbable suture and fascia non-closure | 0.15 (−0.29, 0.59) | 0.505 | 0.15 (−0.29, 0.59) | 0.514 |
- Absorbable suture and fascia closure | −0.24 (−0.69, 0.21) | 0.291 | −0.24 (− 0.69, 0.20) | 0.282 |
- Fascia closure and non-absorbable suture | 0.22 (−0.22, 0.67) | 0.327 | 0.23 (−0.21, 0.68) | 0.309 |
- Fascia closure and absorbable suture | −0.17 (− 0.61, 0.27) | 0.459 | − 0.16 (− 0.60, 0.28) | 0.477 |