Grand Rounds Paper of the week 1. Subcuticular sutures versus staples for skin closure after open...
-
Upload
timothy-gallagher -
Category
Documents
-
view
217 -
download
2
Transcript of Grand Rounds Paper of the week 1. Subcuticular sutures versus staples for skin closure after open...
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, 2013
2
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
12
Results-2Types of diseases and surgical procedures in patients undergoing
upper gastrointestinal surgery Subcuticular sutures (n=385) Staples (n=417)
Diseases
Gastric cancer 375 (97.4%) 403 (96.6%)
Gastric submucosal tumour 6 (1.6%) 9 (2.2%)
Other 4 (1.0%) 5 (1.2%)
Procedures
Total gastrectomy 149 (38.7%) 143 (34.3%)
Distal gastrectomy 186 (48.3%) 219 (52.5%)
Proximal gastrectomy 19 (4.9%) 16 (3.8%)
Exploratory laparotomy 4 (1.0%) 4 (1.0%)
Other 27 (7.0%) 35 (8.4%)13
Results-3Types of diseases and surgical procedures in patients undergoing
lower gastrointestinal surgery
Subcuticular sutures (n=177) Staples (n=101)
Diseases
Colon cancer 98 (55.4%) 51 (50.5%)
Rectal cancer 71 (40.1%) 48 (47.5%)
Anal cancer 2 (1.1%) 1 (1.0%)
Other 6 (3.4%) 1 (1.0%)
Procedures
Right hemicolectomy 41 (23.2%) 28 (27.7%)
Left hemicolectomy 44 (24.9%) 8 (7.9%)
Low anterior resection 61 (34.5%) 38 (37.6%)
Abdominoperineal resecti 11 (6.2%) 10 (9.9%)
Partial resection of colon 9 (5.1%) 10 (9.9%)
Other 11 (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 (0.4-1.0) 0.12
Component outcomes
Surgical site infection (superficial incisional) 36 (6.4%) 36 (7.0%) 0.9 (0.5-1.5) 0.81
Non-surgical-site infection 11 (2.0%) 23 (4.5%) 0.4 (0.1-0.9) 0.02
Wound separation 3 (0.5%) 8 (1.6%) 0.3 (0.0-1.4) 0.13
Seroma 5 (0.9%) 12 (2.3%) 0.3 (0.1-1.1) 0.09
Haematoma 1 (0.2%) 2 (0.4%) 0.4 (0.0-8.9) 0.61
Other 2 (0.4%) 1 (0.2%) 1.8 (0.0-1.3) 115
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 (0.2-0.9) 0.03
Component outcomes
Surgical site infection (superficial incisional) 13 (7.4%) 16 (15.8%) 0.4 (0.1-0.9) 0.03
Non-surgical-site infection 5 (2.8%) 4 (4.0%) 0.7 (0.1-3.6) 0.73
Wound separation 2 (1.1%) 2 (2.0%) 0.5 (0.0-7.9) 0.62
Seroma 2 (1.1%) 1 (1.0%) 1.1 (0.0-1.4) 1
Haematoma 1 (0.6%) 1 (1.0%) 0.5 (0.0-4.3) 1
Other 0 (0.0%) 0 (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 (0.4-1.3) 0.38
Component outcomes
Surgical site infection (superficial incisional) 23 (6.0%) 20 (4.8%) 1.2 (0.6-2.4) 0.53
Non-surgical-site infection 6 (1.6%) 19 (4.6%) 0.3 (0.1-0.8) 0.01
Wound separation 1 (0.3%) 6 (1.5%) 0.1 (0.0-1.4) 0.13
Seroma 3 (0.8%) 11 (2.7%) 0.2 (0.0-1.1) 0.06
Haematoma 0 (0.0%) 1 (0.2%) .. ..
Other 2 (0.5%) 1 (0.2%) 2.1 (0.1-1.1) 0.6117
Results-7Secondary outcomes in the modified intention-to-treat population
Hypertrophic scar formation n Odds ratio (95% CI) p
All patients 0.7 (0.5-0.9) 0.04
Subcuticular sutures 558 93 (16.7%)
Staples 514 111 (21.6%)
Upper gastrointestinal 0.6 (0.4-0.9) 0.02
Subcuticular sutures 382 66 (17.3%)
Staples 413 98 (23.7%)
Lower gastrointestinal 1.2 (0.5-2.7) 0.72
Subcuticular sutures 176 27 (15.3%)
Staples 101 13 (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
Suture Staples
Wound complication
Overall
Upper
Lower
Scar formation
Overall
Upper
Lower 22
Future??
Upper GI
Lower GI
23
Thank you
24