Therapeutics Randomised controlled trial
Study shows insufficient decrease in wound complications with sutured versus stapled skin closure in gastrointestinal operations 10.1136/eb-2013-101626
Hong Vo, Cindy Kin Department of Surgery, Stanford University Medical Center, Stanford, California, USA Correspondence to: Dr Cindy Kin, Department of Surgery, Stanford University Medical Center, 300 Pasteur Drive, H3680 Stanford, CA 94305, USA; [email protected]
Commentary on: Tsujinaka T, Yamamoto K, Fujita J, et al. Subcuticular sutures versus staples for skin closure after open gastrointestinal surgery: a phase 3, multicentre, open-label, randomised controlled trial. Lancet 2013;382:1105–12.
Context Postoperative wound complications can occur in 9–26% of gastrointestinal operations.1–3 Skin closure with subcuticular sutures in clean operations, such as caesarean sections, are associated with decreased wound complications and increased patient satisfaction when compared with skin closure using staples.4 5 Whether these results are applicable to clean–contaminated operations is unknown. Tsujinaka and colleagues examined the incidence of wound complications after open gastrointestinal operations in patients undergoing skin closure with subcuticular sutures versus staples.
sutured versus stapled groups (8.4% vs 11.5%) was not significant, subgroup analysis of lower gastrointestinal operations demonstrated that sutured closure led to half the rates of overall complications (10.2% vs 19.8%, p=0.0301) and superficial surgical site infections (7.4% vs 15.8%, p=0.0399) compared with stapled closure. Investigators also found that sutured closure reduced wound complication risk in male patients with operative time greater than 220 min, and postoperative anticoagulant therapy. Finally, patients undergoing sutured skin closure after upper gastrointestinal surgery had a lower rate of hypertrophic scar formation (17.3% vs 23.7%, p=0.0282). As the study failed to demonstrate a 5% decrease in overall wound complications, the authors do not advocate that subcuticular sutures be adopted as the standard for open gastrointestinal surgery.
Commentary Tsujinaka and colleagues present a timely prospective trial examining the effect of skin closure method on wound complications in cleancontaminated operations. In our era of heightened cost-consciousness, potentially preventable complications like wound infections are heavily scrutinised. Surgical site infections are expensive, costing private insurance payers an additional US$17 324 and more than doubling the cost of a colectomy, while increasing the length of stay.2 6 Although the study did find a decrease in wound infections for sutured closure in lower gastrointestinal operations, the authors conclude that the lack of a significant difference in the overall group precludes a recommendation for clean–contaminated cases. Meta-analyses examining the effect of sutured versus stapled skin closure on wound infections in clean cases, such as saphenous vein graft harvesting and hip arthroplasty, are also equivocal.7 8 The authors did not discuss the inter-institution variability of wound complication rates. While the methods of skin closure were standardised, the use of prophylactic antibiotics, skin preparation and timing of staple removal were left to the discretion of the individual institution. Such factors may indeed affect wound complication rate. Another confounding factor that may have contributed to the higher rate of wound infection in lower gastrointestinal operations is the presence of an ostomy.6 Competing interests None.
Methods This multicentre unblinded randomised controlled trial included patients, aged ≥20 years and with adequate organ function, undergoing elective open gastrointestinal operations. Exclusion criteria included emergent operations, prior midline laparotomy, corticosteroid therapy, concomitant infections and comorbidities such as insulin-dependent diabetes. A computerised program randomised patients to skin closure with subcuticular sutures or staples. Surgeons used standardised interrupted suturing and stapling techniques. The primary endpoint was occurrence of wound complications in the first 30 postoperative days. In addition to superficial surgical site infections, wound complications also included abscess from a stitch or metal allergy, and seroma or haematoma. The secondary endpoint was a hypertrophic scar identified at the 6-month postoperative visit. The investigators used Fisher’s exact test for primary and secondary outcomes, and adjusted for potential confounders in their post hoc analysis.
Findings Of 1072 patients, 558 underwent skin closure with sutures and 514 with staples. While the difference in overall wound complication rate in the
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Evid Based Med June 2014 | volume 19 | number 3 |
References 1. Smith RL, Bohl JK, McElearney ST, et al. Wound infection after elective colorectal resection. Ann Surg 2004;239:599–605; discussion 605–7. 2. Wick EC, Hirose K, Shore AD, et al. Surgical site infections and cost in obese patients undergoing colorectal surgery. Arch Surg 2011;146:1068–72. 3. Itani KM, Wilson SE, Awad SS, et al. Ertapenem versus cefotetan prophylaxis in elective colorectal surgery. N Engl J Med 2006;355:2640–51. 4. Figueroa D, Jauk VC, Szychowski JM, et al. Surgical staples compared with subcuticular suture for skin closure after cesarean delivery: a randomized controlled trial. Obstet Gynecol 2013;121:33–8. 5. Johnson RG, Cohn WE, Thurer RL, et al. Cutaneous closure after cardiac operations: a controlled, randomized, prospective comparison of intradermal versus staple closures. Ann Surg 1997;226:606–12. 6. Mahmoud NN, Turpin RS, Yang G, et al. Impact of surgical site infections on length of stay and costs in selected colorectal procedures. Surg Infect (Larchmt) 2009;10:539–44. 7. Biancari F, Tiozzo V. Staples versus sutures for closing leg wounds after vein graft harvesting for coronary artery bypass surgery. Cochrane Database Syst Rev 2010;5: CD008057. 8. Smith TO, Sexton D, Mann C, et al. Sutures versus staples for skin closure in orthopaedic surgery: meta-analysis. BMJ 2010;340:c1199.
Study shows insufficient decrease in wound complications with sutured versus stapled skin closure in gastrointestinal operations 10.1136/eb-2013-101626
Hong Vo, Cindy Kin Department of Surgery, Stanford University Medical Center, Stanford, California, USA Correspondence to: Dr Cindy Kin, Department of Surgery, Stanford University Medical Center, 300 Pasteur Drive, H3680 Stanford, CA 94305, USA; [email protected]
Commentary on: Tsujinaka T, Yamamoto K, Fujita J, et al. Subcuticular sutures versus staples for skin closure after open gastrointestinal surgery: a phase 3, multicentre, open-label, randomised controlled trial. Lancet 2013;382:1105–12.
Context Postoperative wound complications can occur in 9–26% of gastrointestinal operations.1–3 Skin closure with subcuticular sutures in clean operations, such as caesarean sections, are associated with decreased wound complications and increased patient satisfaction when compared with skin closure using staples.4 5 Whether these results are applicable to clean–contaminated operations is unknown. Tsujinaka and colleagues examined the incidence of wound complications after open gastrointestinal operations in patients undergoing skin closure with subcuticular sutures versus staples.
sutured versus stapled groups (8.4% vs 11.5%) was not significant, subgroup analysis of lower gastrointestinal operations demonstrated that sutured closure led to half the rates of overall complications (10.2% vs 19.8%, p=0.0301) and superficial surgical site infections (7.4% vs 15.8%, p=0.0399) compared with stapled closure. Investigators also found that sutured closure reduced wound complication risk in male patients with operative time greater than 220 min, and postoperative anticoagulant therapy. Finally, patients undergoing sutured skin closure after upper gastrointestinal surgery had a lower rate of hypertrophic scar formation (17.3% vs 23.7%, p=0.0282). As the study failed to demonstrate a 5% decrease in overall wound complications, the authors do not advocate that subcuticular sutures be adopted as the standard for open gastrointestinal surgery.
Commentary Tsujinaka and colleagues present a timely prospective trial examining the effect of skin closure method on wound complications in cleancontaminated operations. In our era of heightened cost-consciousness, potentially preventable complications like wound infections are heavily scrutinised. Surgical site infections are expensive, costing private insurance payers an additional US$17 324 and more than doubling the cost of a colectomy, while increasing the length of stay.2 6 Although the study did find a decrease in wound infections for sutured closure in lower gastrointestinal operations, the authors conclude that the lack of a significant difference in the overall group precludes a recommendation for clean–contaminated cases. Meta-analyses examining the effect of sutured versus stapled skin closure on wound infections in clean cases, such as saphenous vein graft harvesting and hip arthroplasty, are also equivocal.7 8 The authors did not discuss the inter-institution variability of wound complication rates. While the methods of skin closure were standardised, the use of prophylactic antibiotics, skin preparation and timing of staple removal were left to the discretion of the individual institution. Such factors may indeed affect wound complication rate. Another confounding factor that may have contributed to the higher rate of wound infection in lower gastrointestinal operations is the presence of an ostomy.6 Competing interests None.
Methods This multicentre unblinded randomised controlled trial included patients, aged ≥20 years and with adequate organ function, undergoing elective open gastrointestinal operations. Exclusion criteria included emergent operations, prior midline laparotomy, corticosteroid therapy, concomitant infections and comorbidities such as insulin-dependent diabetes. A computerised program randomised patients to skin closure with subcuticular sutures or staples. Surgeons used standardised interrupted suturing and stapling techniques. The primary endpoint was occurrence of wound complications in the first 30 postoperative days. In addition to superficial surgical site infections, wound complications also included abscess from a stitch or metal allergy, and seroma or haematoma. The secondary endpoint was a hypertrophic scar identified at the 6-month postoperative visit. The investigators used Fisher’s exact test for primary and secondary outcomes, and adjusted for potential confounders in their post hoc analysis.
Findings Of 1072 patients, 558 underwent skin closure with sutures and 514 with staples. While the difference in overall wound complication rate in the
100
Evid Based Med June 2014 | volume 19 | number 3 |
References 1. Smith RL, Bohl JK, McElearney ST, et al. Wound infection after elective colorectal resection. Ann Surg 2004;239:599–605; discussion 605–7. 2. Wick EC, Hirose K, Shore AD, et al. Surgical site infections and cost in obese patients undergoing colorectal surgery. Arch Surg 2011;146:1068–72. 3. Itani KM, Wilson SE, Awad SS, et al. Ertapenem versus cefotetan prophylaxis in elective colorectal surgery. N Engl J Med 2006;355:2640–51. 4. Figueroa D, Jauk VC, Szychowski JM, et al. Surgical staples compared with subcuticular suture for skin closure after cesarean delivery: a randomized controlled trial. Obstet Gynecol 2013;121:33–8. 5. Johnson RG, Cohn WE, Thurer RL, et al. Cutaneous closure after cardiac operations: a controlled, randomized, prospective comparison of intradermal versus staple closures. Ann Surg 1997;226:606–12. 6. Mahmoud NN, Turpin RS, Yang G, et al. Impact of surgical site infections on length of stay and costs in selected colorectal procedures. Surg Infect (Larchmt) 2009;10:539–44. 7. Biancari F, Tiozzo V. Staples versus sutures for closing leg wounds after vein graft harvesting for coronary artery bypass surgery. Cochrane Database Syst Rev 2010;5: CD008057. 8. Smith TO, Sexton D, Mann C, et al. Sutures versus staples for skin closure in orthopaedic surgery: meta-analysis. BMJ 2010;340:c1199.
