Behera 2016.

Study characteristics
Methods	Study design: randomised controlled, hospital‐based, parallel designed, and single (rater) blinded study, conducted in a tertiary care Institute, in South India. Participants as the unit of randomisation but multiple scar per person. Duration of the study: November 2011 to November 2013 Follow‐up time: 12 months (long‐term follow‐up) Protocol was published before recruitment of participants: the study was conducted after obtaining Institute ethics committee clearance and bears trial registration number Details of trial registration: bears trial registration number CTRI/2015/01/005400 Funding sources: none declared
Participants	Number of participants assigned: 60 participants (with a total of 101 scars treated). Group 1 (1 CO2 laser session plus 4 intralesional TAC sessions): 30 individuals (with a total of 56 keloid scars treated) Group 2 (1 cryosurgery session plus 4 intralesional TAC sessions): 30 individuals (with a total of 45 keloid scars treated) Loss: 23 participants (13 from group 1, 10 from group 2) Number of participants assessed: 37 participants Group 1: 17 individuals Group 2: 20 individuals Inclusion criteria: patients with ≤ 5 keloids of size ≤ 5 cm in longest diameter were included Exclusion criteria: people aged less than 12 years; people with infected keloids or with coexisting inflammatory skin diseases (psoriasis, lichen planus, eczemas etc.); people with unrealistic expectations or psychiatric illnesses; people with a pre‐existing bleeding disorder, renal or hepatic disease; pregnant/lactating people. Age, gender, and duration of keloids in Group 1 and Group 2: the author only described that the participant characteristics were comparable between the 2 groups with respect to age, gender, and duration of the keloid. No further information was available. Scar Location: Group 1: presternal: 26; chest: 10; shoulder: 7; upper limb: 7; breast: 2; lower limb: 2; ear: 1; back: 1 Group 2: chest: 14; presternal: 10; shoulder: 9; upper limb: 5; lower limb: 5; ear: 1; breast: 1
Interventions	Group 1 (1 CO2 laser session plus 4 intralesional TAC sessions): participants were treated with carbon dioxide laser (COLMS, DINONA), in continuous mode, with maximum power up to 10 W, followed by intralesional triamcinolone acetonide (ILTAC) injection. After this, the patients were given ILTA (40 mg/mL) every month for 3 months. Group 2 (1 cryosurgery session plus 4 intralesional TAC sessions): participants were treated with cryotherapy using contact cryoprobe with 2 freeze thaw cycles of 20 seconds (Frigitronics, Nitrous oxide as cryogen) followed by ILTAC injection. After this, the patients were given ILTAC (40 mg/mL) every month for 3 months.
Outcomes	Primary outcomes Overall Appearance (by Patient Self‐assessment): Assessed by participants at 3, 6, and 12 months and graded on a 5‐point scale as, no improvement; poor = up to 25% improvement; fair = 26% to 50% improvement; good = 51% to 75% improvement; and excellent = 76% to 100% improvement Overall Appearance (Observer Assessment): Assessed by 2 blinded observers at 3, 6, and 12 months, based on a serial photograph and graded on a 5‐point scale as, no improvement; poor = up to 25% improvement; fair = 26% to 50% improvement; good = 51% to 75% improvement; and excellent = 76% to 100% improvement Vancouver Burn Scar Assessment Scale (VBS): Assessed at 3, 6, and 12 months and graded on a 5‐point scale as, no improvement; poor = up to 25% improvement; fair = 26% to 50% improvement; good = 51% to 75% improvement; and excellent = 76% to 100% improvement   Treatment‐related adverse effects: The evaluation of participants's treatment‐related adverse effects was done by a blinded investigator during the study. Secondary Outcomes: Change in scar height: a dial calliper was used to determine the percentage of height reduction of the lesion (in mm) Change in scar volume: reduction of scar volume was evaluated but the method used to assess this parameter was not described Change in scar pain: reduction of scar pain was evaluated but the method used to assess this parameter was not described Change in scar pruritus: reduction of scar pruritus was evaluated but the method used to assess this parameter was not described
Notes	Vancouver Burn Scar Assessment Scale (VBS) is cited along this study as Vancouver Scar Scale (VSS). Cryosurgery is cited along this study as cryotherapy. The authors have indicated no significant interest with commercial supporters.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Patients were randomised by simple randomisation"
Allocation concealment (selection bias)	Low risk	Quote: "The allocation was concealed and noted in a sealed file and not handed over till statistical analysis was completed by investigator"
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants and health professionals performing the treatment were not blinded.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Results were assessed by a blinded observer.
Incomplete outcome data (attrition bias) All outcomes	High risk	Twenty‐three of the 60 participants did not complete the study. The reasons were not specified.
Selective reporting (reporting bias)	Unclear risk	The protocol was retrospectively registered (CTRI/2015/01/005400). All parameters listed in the methods section to assess changes in the scars were described, however, the method used to assess the lesion's volume was not described.
Other bias	Low risk	No other sources of bias were found.