Grand Rounds Paper of the week 1

Subcuticular sutures versus staples for skin closure after open gastrointestinal surgery: a phase 3, multicentre, open- label, randomised controlled trial Tsujinaka et al, The Lancet 28 September-04 October,

Introduction-1 Post op wound complications are common problem Sub-cuticular suture (SCS) is an attractive way of skin closure in most types of surgery Many ASA class 1 (clean surgery) studies with SCS found –Low wound complications –Good cosmetic appearance 3

Introduction-2 However in ASA class 2 (clean- contaminated) wounds the usefulness of one over the other is not know Staples are preferred –Convenience of use –Speed of use 4

Study aims To investigate differences in prevention of wound complications between sub- cuticular sutures and staples after elective upper and lower gastrointestinal open surgery 5

The Fight Vs 6

Study design-1 Large-scale multi-centre phase 3 randomised control trial B/t June 1, 2009 and Feb 28, 2012 Superiority trial 7

Study design-2 Inclusion criteria –Pt undergoing Upper or lower GI surgery –Age >20 –Adequate organ function Exclusion criteria (among others) –Emergency or laparoscopic surgery –Pervious history of midline incision –Long term corticosteroids use –Active infections –Uncontrolled DM 8

Study arms Subcuticular suture group –Interrupted subcuticular sutures with 3-0 or 4-0 monofilament absorbable suture –The interval of the sucuticular sutures was 15–25 mm and the length of the bite of sutures was 15–25 mm from the edge of the skin. –± Use of sterile strips or skin glue for epidermal approximation (an institutional choice) Staples group –Metallic skin staples, which were the choice of individual institutions, 10–15 mm apart were used. –Before the trial, investigators from participating institutions were instructed on how to do subcuticular sutures during the trial 9

Randomisation Randomisation by a computer-generated permuted-block sequence Patients were randomly assigned (1:1) to either subcuticular sutures or staples arms and Balanced according to institution, sex, and type of surgery (ie. upper or lower gastrointestinal open surgery) 10

Study outcomes Primary outcome – Incidence of wound complications within 30 days of surgery. Secondary outcome – Incidence of hypertrophic scar formation 6 months after surgery 11

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Results-2 Types of diseases and surgical procedures in patients undergoing upper gastrointestinal surgery Subcuticular sutures (n=385)Staples (n=417) Diseases Gastric cancer375 (97.4%)403 (96.6%) Gastric submucosal tumour6 (1.6%)9 (2.2%) Other4 (1.0%)5 (1.2%) Procedures Total gastrectomy149 (38.7%)143 (34.3%) Distal gastrectomy186 (48.3%)219 (52.5%) Proximal gastrectomy19 (4.9%)16 (3.8%) Exploratory laparotomy4 (1.0%) Other27 (7.0%)35 (8.4%) 13

Results-3 Types of diseases and surgical procedures in patients undergoing lower gastrointestinal surgery Subcuticular sutures (n=177) Staples (n=101) Diseases Colon cancer98 (55.4%)51 (50.5%) Rectal cancer71 (40.1%)48 (47.5%) Anal cancer2 (1.1%)1 (1.0%) Other6 (3.4%)1 (1.0%) Procedures Right hemicolectomy41 (23.2%)28 (27.7%) Left hemicolectomy44 (24.9%)8 (7.9%) Low anterior resection61 (34.5%)38 (37.6%) Abdominoperineal resecti11 (6.2%)10 (9.9%) Partial resection of colon9 (5.1%)10 (9.9%) Other11 (6.2%)7 (6.9%) 14

Results-4 All patients Subcuticular suture (n=558) Staples (n=514) Odds ratio (95% CI)p Primary outcome Wound complication rate*47 (8.4%)59 (11.5%)0.7 ( )0.12 Component outcomes Surgical site infection (superficial incisional)36 (6.4%)36 (7.0%)0.9 ( )0.81 Non-surgical-site infection11 (2.0%)23 (4.5%)0.4 ( )0.02 Wound separation3 (0.5%)8 (1.6%)0.3 ( )0.13 Seroma5 (0.9%)12 (2.3%)0.3 ( )0.09 Haematoma1 (0.2%)2 (0.4%)0.4 ( )0.61 Other2 (0.4%)1 (0.2%)1.8 ( )1 15

Results-5 Upper gastrointestinal surgery Subcuticular sutures (n=176) Staples (n=101) Odds ratio (95% CI)p Primary outcome Wound complication rate*18 (10.2%)20 (19.8%)0.4 ( )0.03 Component outcomes Surgical site infection (superficial incisional)13 (7.4%)16 (15.8%)0.4 ( )0.03 Non-surgical-site infection5 (2.8%)4 (4.0%)0.7 ( )0.73 Wound separation2 (1.1%)2 (2.0%)0.5 ( )0.62 Seroma2 (1.1%)1 (1.0%)1.1 ( )1 Haematoma1 (0.6%)1 (1.0%)0.5 ( )1 Other0 (0.0%).. 16

Results-6 Lower gastrointestinal surgery Subcuticular sutures (n=382) Staples (n=413) Odds ratio (95% CI)p Primary outcome Wound complication rate*29 (7.6%)39 (9.4%)0.7 ( )0.38 Component outcomes Surgical site infection (superficial incisional)23 (6.0%)20 (4.8%)1.2 ( )0.53 Non-surgical-site infection6 (1.6%)19 (4.6%)0.3 ( )0.01 Wound separation1 (0.3%)6 (1.5%)0.1 ( )0.13 Seroma3 (0.8%)11 (2.7%)0.2 ( )0.06 Haematoma0 (0.0%)1 (0.2%).. Other2 (0.5%)1 (0.2%)2.1 ( )

Results-7 Secondary outcomes in the modified intention-to-treat population Hypertrophic scar formationnOdds ratio (95% CI)p All patients 0.7 ( )0.04 Subcuticular sutures55893 (16.7%) Staples (21.6%) Upper gastrointestinal 0.6 ( )0.02 Subcuticular sutures38266 (17.3%) Staples41398 (23.7%) Lower gastrointestinal 1.2 ( )0.72 Subcuticular sutures17627 (15.3%) Staples10113 (12.9%) 18

Discussion 1 Strengths –Level 1 evidence (RCT) –Simple methodology –Large study and long duration –Surgeon well trained to put suture/staples –Information about surgery at upper vs lower GI –Cant be double/single blinded 19

Discussion 2 Weakness –No data on number of patients approached or assessed for eligibility –Third arm with skin glue could be used –Did not include hepatobiliary or pancreatic surgery –No data on duration of surgery, patients' satisfaction, patients' preference 20

Conclusions Unlike in ASA class 1 surgery this trial failed to prove subcuticular sutures were a new standard procedure for skin closure after gastrointestinal surgery; The formation of hypertrophic scars was significantly reduced with subcuticular sutures compared with staples 21

Take home message Like/Unlike SutureStaples Wound complication Overall Upper Lower Scar formation Overall Upper Lower 22

Future?? Upper GI Lower GI 23

Thank you 24