Summary of findings 3. Laser therapy plus other treatment compared with other treatment for treating hypertrophic and keloid scars.
| Laser therapy plus other treatment compared with other treatment for treating hypertrophic and keloid scars | ||||||
| Patient or population: participants with hypertrophic and keloid scars Setting: outpatient Intervention: laser therapy (various types ‐ 585‐nm Pulsed‐Dye Laser (PDL), erbium laser, carbon dioxide (CO2) laser, Neodymium‐doped yttrium aluminium garnet (Nd:YAG) laser, Helium‐Neon (He‐Ne) laser) plus other treatments (various types ‐ triamcinolone acetonide (TAC), 5‐Fluorouracil (5‐FU), Diprospan, decamethyltetrasiloxane, polydimethylsiloxane and cyclopentasiloxane cream and verapamil) Comparison: other treatments (various types ‐ triamcinolone acetonide (TAC), 5‐Fluorouracil (5‐FU), Diprospan, decamethyltetrasiloxane, polydimethylsiloxane and cyclopentasiloxane cream, cryosurgery and verapamil) | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of scar segments (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with other treatment | Risk with Laser therapy plus other treatment | |||||
| Scar severity ‐ 585‐nm pulsed‐dye laser (PDL) plus triamcinolone acetonide (TAC) plus 5‐Fluorouracil (5‐FU) versus TAC plus 5‐FU ‐ blinded observer assessment of good to excellent scar improvement ‐ hypertrophic and keloid scars ‐ follow‐up: 12 weeks | Study population | RR 1.75 (0.95 to 3.22) |
40 (1 study) | ⊕⊝⊝⊝1,2 Very low | It is uncertain whether there is any difference in the scar severity in PDL plus TAC plus 5‐FU‐treated hypertrophic and keloid scars compared with TAC plus 5‐FU after 12 weeks. | |
| 400 per 1000 | 700 per 1000 | |||||
| Scar severity ‐ 585‐nm PDL plus TAC plus 5 FU versus TAC plus 5‐FU ‐ patient self‐assessment of good to excellent scar improvement ‐ hypertrophic and keloid scars ‐ follow‐up: 12 weeks | Study population | RR 1.36 (0.85 to 2.18) |
40 (1 study) | ⊕⊝⊝⊝1,3 Very low | ||
| 550 per 1000 | 748 per 1000 | |||||
| Scar severity ‐ carbon dioxide (CO2) laser plus TAC versus cryosurgery plus TAC. Mean percentage reduction ‐ blinded observer assessment ‐ keloid scars ‐ follow‐up: 12 months | Study population | NA | 60 (1 study) |
⊕⊝⊝⊝4,5 Very low | It is uncertain whether there is any difference in the scar severity in CO2 plus TAC‐treated keloid scars compared with cryosurgery plus TAC after 12 months. | |
| Baseline mean in the other treatment group was 74.44 | MD 16.11 lower (34.49 lower to 2.27 higher) | |||||
| Scar severity ‐ CO2 laser plus TAC versus cryosurgery plus TAC Mean percentage reduction ‐ patient self‐assessment score (higher scores = worse scar appearance) ‐ keloid scars ‐ follow‐up: 12 months | Study population | NA | 60 (1 study) |
⊕⊝⊝⊝4,6 Very low | ||
| Baseline mean in the other treatment group was 74.26 | MD 7.59 lower (22.83 lower to 7.65 higher) | |||||
| Incidence of treatment‐related adverse effects: CO2 laser plus TAC versus cryosurgery plus TAC ‐ atrophy ‐ keloid scars ‐ follow‐up: 12 months | Study population | RR 1.13 (0.70 to 1.82) |
60 (1 study) |
⊕⊝⊝⊝4,6 Very low | It is uncertain whether there is any difference in the incidence and severity of treatment‐related adverse effects in CO2 plus TAC‐treated keloid scars compared with cryosurgery plus TAC after 12 months. |
|
| 500 per 1000 | 565 per 1000 | |||||
| Incidence of treatment‐related adverse effects ‐ CO2 laser plus TAC versus cryosurgery plus TAC ‐ erythema ‐ keloid scars ‐ follow‐up: 12 months | Study population | RR 1.50 (0.47 to 4.78) |
60 (1 study) |
⊕⊝⊝⊝4,6 Very low | ||
| 133 per 1000 | 200 per 1000 | |||||
| Incidence of treatment‐related adverse effects ‐ CO2 laser plus TAC versus cryosurgery plus TAC ‐ telangiectasia ‐ keloid scars ‐ follow‐up: 12 months | Study population | RR 0.33 (0.07 to 1.52) |
60 (1 study) |
⊕⊝⊝⊝4,6 Very low | ||
| 200 per 1000 | 66 per 1000 | |||||
| Incidence of treatment‐related adverse effects ‐ CO2 laser plus TAC versus cryosurgery plus TAC ‐ hypopigmentation ‐ keloid scars ‐ follow‐up: 12 months | Study population | RR 0.60 (0.16 to 2.29) |
60 (1 study) |
⊕⊝⊝⊝4,6 Very low | ||
| 167 per 1000 | 100 per 1000 | |||||
| Scar severity ‐ Neodymium‐doped yttrium aluminium garnet (Nd:YAG) laser plus Diprospan plus 5‐FU versus Diprospan plus 5‐FU ‐ blinded observer assessment of good to excellent scar improvement ‐ keloid scars ‐ follow‐up: 3 months | Study population | RR 1.45 (0.88 to 2.41) |
46 (1study) |
⊕⊝⊝⊝1,7 Very low | It is uncertain whether there is any difference in the scar severity in Nd:YAG plus Diprospan plus 5‐FU‐treated keloid scars compared with Diprospan plus 5‐FU after 3 months. | |
| 478 per 1000 | 693 per 1000 | |||||
| Scar severity: Nd:YAG laser plus Diprospan plus 5‐FU versus Diprospan plus 5‐FU ‐ patient self‐assessment of scar improvement of 50% or higher ‐ keloid scars ‐ follow‐up: 3 months | Study population | RR 1.38 (0.91 to 2.10) |
46 (1study) |
⊕⊝⊝⊝1,8 Very low | ||
| 565 per 1000 | 780 per 1000 | |||||
| Incidence and severity of treatment‐related adverse effects: Nd:YAG laser plus Diprospan plus 5‐FU versus Diprospan plus 5‐FU ‐ keloid scars ‐ follow‐up: 3 months | One parallel trial (n = 46) reported this outcome. In this study, almost all injections were reported by participants as being painful, and the sites treated by Nd:YAG laser became purpuric (which lasted for 7 to 10 days). | ⊕⊝⊝⊝1,8 Very low | It is uncertain whether there is any difference in the incidence and severity of treatment‐related adverse effects in Nd:YAG plus Diprospan plus 5‐FU‐treated keloid scars compared with Diprospan plus 5‐FU after 3 months. | |||
| Scar severity ‐ Helium‐Neon (He‐Ne) laser plus decamethyltetrasiloxane, polydimethylsiloxane and cyclopentasiloxane cream versus decamethyltetrasiloxane, polydimethylsiloxane and cyclopentasiloxane cream ‐ Vancouver Scar scale (VSS) (higher scores = worse scar appearance) ‐ hypertrophic scars ‐ follow‐up: 12 weeks | One split‐scar trial (n = 30) reported this outcome. In this study, a significant decrease in the median values of VSS of the intervention area compared with the control area (P = 0.003) | ⊕⊝⊝⊝4,9 Very low | It is uncertain whether there is any difference in the scar severity in He‐Ne plus decamethyltetrasiloxane, polydimethylsiloxane and cyclopentasiloxane cream‐treated hypertrophic scars compared with decamethyltetrasiloxane, polydimethylsiloxane and cyclopentasiloxane cream after 12 weeks. | |||
| Incidence of treatment‐related adverse effects ‐ 595‐nm PDL plus verapamil versus verapamil ‐ regrowth ‐ keloid scars ‐ follow‐up: 24 weeks | Study population | RR 1.50 (0.27 to 8.22) |
50 (1study) |
⊕⊝⊝⊝1,10 Very low | It is uncertain whether there is any difference in the incidence and severity of treatment‐related adverse effects in PDL plus verapamil‐treated keloid scars compared with verapamil after 24 weeks. |
|
| 80 per 1000 | 120 per 1000 | |||||
| Incidence of treatment‐related adverse effects ‐ 595‐nm PDL plus verapamil versus verapamil ‐ pain related to treatment ‐ keloid scars ‐ follow‐up: 24 weeks | One parallel trial (n = 50) reported this outcome. In this study, pain at injection site was reported by 1 out of 25 (1/25) (4%) participants treated with 595‐nm PDL plus verapamil and by 0 out of 25 (0/15) (0%) participants treated with verapamil (RR 3.00; 0.13 to 70.30) | ⊕⊝⊝⊝1,10 Very low | ||||
| Incidence of treatment‐related adverse effects ‐ 595‐nm PDL plus verapamil versus verapamil ‐ hyperpigmentation ‐ keloid scars ‐ follow‐up: 24 weeks | One parallel trial (n = 50) reported this outcome. In this study, hyperpigmentation was observed in 2 out of 25 (2/25) (8%) participants treated with 595‐nm PDL plus verapamil and by 0 out of 25 (0/15) (0%) participants treated with verapamil (RR 5.00; 0.25 to 99.16) | ⊕⊝⊝⊝1,10 Very low | ||||
| Incidence of treatment‐related adverse effects ‐ 595‐nm PDL plus verapamil versus verapamil ‐ depigmentation ‐ keloid scars ‐ follow‐up: 24 weeks | Study population | RR 1.00 (0.07 to 15.12) |
50 (1study) |
⊕⊝⊝⊝1,10 Very low | ||
| 40 per 1000 | 40 per 1000 | |||||
| Incidence of treatment‐related adverse effects ‐ 595‐nm PDL plus verapamil versus verapamil ‐ purpura ‐ keloid scars ‐ follow‐up: 24 weeks | One parallel trial (n = 50) reported this outcome. In this study, hyperpigmentation was observed in 7 out of 25 (7/25) (28%) participants treated with 595‐nm PDL plus verapamil and by 0 out of 25 (0/15) (0%) participants treated with verapamil (RR 15.00; 0.90 to 249.30) | ⊕⊝⊝⊝1,10 Very low | ||||
| Incidence of treatment‐related adverse effects ‐ 595‐nm PDL plus verapamil versus verapamil ‐ total ‐ keloid scars ‐ follow‐up: 24 weeks | Study population | RR 4.67 (1.53 to 14.26) |
50 (1study) |
⊕⊝⊝⊝1,10 Very low | ||
| 120 per 1000 | 560 per 1000 | |||||
| *The risk in the intervention group (and its 95% confidence interval) is based on the mean risk in the comparison group and the relative effect of the intervention (and its 95% CI). ƚThe assumed risk in the comparison group is based on the event rate observed in the control arms of included trials. Where no events occurred, the risk was not calculated. ‐ Diprospan contains betamethasone disodium phosphate plus betamethasone dipropionate. Patient self‐assessment ‐ based on a 4‐point scale (1 = 0 to 25% improvement, 2 = 25 to 50% improvement, 3 = 50 to 75% improvement, and 4 = 75% or greater improvement); VBS: Vancouver Burn Scar Assessment Scale ‐ severity of scar was determined by numeric value from a minimum of 0 to 13 as the most severe form. CI: Confidence Interval; ; CO:2 carbon dioxide;5‐FU: 5‐fluorouracil; He‐Ne: Helium‐Neon; NdYAG:neodymium‐doped yttrium aluminium garnet; PDL: Pulsed‐Dye Laser; RR: Risk Ratio; TAC: Triamcinolone acetonide. | ||||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect. | ||||||
1 Downgraded 2 levels for very serious imprecision due to small number of events and large confidence interval.
2 Downgraded 1 level due to serious risk of bias (lack of blinding of participants, incomplete outcome data and selective reporting, and unclear sequence generation and allocation concealment).
3 Downgraded 1 level due to serious risk of bias (lack of blinding of participants and assessors (patient‐reported outcome), incomplete outcome data and selective reporting, and unclear sequence generation and allocation concealment)
4 Downgraded 2 levels for very serious imprecision due to small sample size and large confidence interval.
5 Downgraded 1 level due to serious risk of bias (lack of blinding of participants and incomplete outcome data, and unclear selective reporting).
6 Downgraded 1 level due to serious risk of bias (lack of blinding of participants and assessors (patient‐reported outcome) and incomplete outcome data, and unclear selective reporting).
7 Downgraded 1 level due to serious risk of bias (lack of blinding of participants and incomplete outcome data, and unclear sequence generation and allocation concealment).
8 Downgraded 1 level due to serious risk of bias (lack of blinding of participants and assessors (patient‐reported outcome) and incomplete outcome data, and unclear sequence generation and allocation concealment).
9 Downgraded 1 level due to serious risk of bias (lack of blinding of participants and selective reporting, and unclear sequence generation, allocation concealment and incomplete outcome data).
10 Downgraded 1 level due to serious risk of bias (lack of blinding of participants and assessors (patient‐reported outcome), and unclear sequence generation, allocation concealment and incomplete outcome data).