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Grand Rounds Paper of the week

Grand Rounds Paper of the week. 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, 2013. Introduction-1.

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Grand Rounds Paper of the week

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  1. Grand RoundsPaper of the week

  2. 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, 2013

  3. 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

  4. 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

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

  6. The Fight Vs

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

  8. 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

  9. 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

  10. 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)

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

  12. Results-2

  13. Results-3

  14. Results-4

  15. Results-5

  16. Results-6

  17. Results-7

  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

  22. Future?? Upper GI Lower GI

  23. Thank you

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