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. 2013 Sep 12;2013(9):CD003826. doi: 10.1002/14651858.CD003826.pub3

Wittenberg 1999.

Methods RCT
Participants Teaching Hospital, USA
 20 patients
 Inclusion criteria: adults with uniform, linear hypertrophic scars secondary to surgical wounds
 Exclusion criteria: treatment of the scar within the preceding 2 months, keloidal scarring, scars less than 8 cm long
 Sex: 5 male, 15 female
 Age: 24 to 81
Interventions Each scar was divided into 3 sections, and each section was randomly assigned to 1 of 2 treatments (585 nm pulsed laser or silicone gel sheet) or designated as a control
Outcomes Length of follow‐up: measurements at 0, 8, 16, 24 and 40 weeks
 Clinical: hypertrophic scar blood flow, elasticity and volume
 Histological assessment of fibrosis, number of telangiectasias, number of mast cells
 Patient' subjective complaints of pruritis, pain and burning
 Consenting patients (n = 5) underwent punch biopsies at 0 and 40 weeks
 Complications: 1 patient unable to use silicone gel sheet due to skin irritation, 1 patient withdrew because of pain during laser treatment
Notes Elasticity measured by elastometer
 Blood flow measured with a laser Doppler
 Patients rated pain and burning on a quartile scale (1 = no/minimal pain, 4 = severe)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: “Each scar was divided into three sections and each section was either randomly assigned to 1 of 2 treatments (SGS or FLPDL) or designated as control using a computer‐generated randomization list”.
Comment: we judged randomisation to be adequate
Allocation concealment (selection bias) Unclear risk Comment: no information is given on allocation concealment which we judged to be at unclear risk of bias
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: “Patients were instructed to wear silicone gel sheeting on the designated site for at least 12 continuous hours per day . . . one section of the patients scar underwent flash lamp‐pumped pulsed‐dye laser . . . one section was randomised to control and left untreated for the study duration”.
Comment: due to the nature of the treatment, we judged that participants and personnel could not be blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: no information was given regarding outcome assessment which we judged to be at unclear risk of bias
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: “20 [patients] were enrolled in the study. Patient 10 did not use SGS due to skin irritation. Patient 6 dropped out of the study at week 24 because of pain during laser treatment".
Comment: loss to follow‐up was less than 20% and we therefore judged it to be at low risk of bias
Selective reporting (reporting bias) Low risk Comment: the study protocol was not sought, however all measurements discussed in the methods are reported in the results and clinically meaningful outcomes presented.
Other bias High risk Quote: “We thank Smith and Nephew for supplying silicone gel sheeting”
Comment: Smith & Nephew was the brand of silicone gel used in the trial. We judged this to cause a high risk of bias.

CCT: controlled clinical trial; ITT: intention‐to‐treat; RCT: randomised controlled trial; SD: standard deviation