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Single‐ vs multiple‐layer wound closure for flank incisions: results of a prospective, randomised, double‐blinded multicentre study
Author(s) -
Kriegmair Maximilian C.,
Younsi Nina,
Hiller Kiriaki,
Leitsmann Conrad,
Kowalewski Karl F.,
Siegel Fabian,
Rothamel Martin,
Ritter Manuel,
Bolenz Christian,
Kriegmair Martin,
Trojan Lutz,
Michel Maurice S.
Publication year - 2021
Publication title -
bju international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.773
H-Index - 148
eISSN - 1464-410X
pISSN - 1464-4096
DOI - 10.1111/bju.15148
Subject(s) - medicine , flank , surgery , confidence interval , odds ratio , visual analogue scale , incidence (geometry) , randomized controlled trial , prospective cohort study , anesthesia , physics , optics , anatomy
Objective To compare the incidence of postoperative flank bulges between patients with multiple‐layer closure and single superficial‐layer closure after retroperitoneal surgery via open flank incision in the SIngle versus MUltiple‐LAyer wound Closure for flank incision (SIMULAC) trial. Patients and Methods The study was a randomised controlled, patient‐ and assessor‐blinded, multicentre trial. Between May 2015 and February 2017, 225 patients undergoing flank incisions were randomised 1:1 to a multiple‐layer closure (SIMULAC‐I) or a single superficial‐layer closure (SIMULAC‐II) group. The primary outcome was the occurrence of a flank bulge 6 months after surgery. Results Overall, 177 patients (90 in SIMULAC‐I, 87 in SIMULAC‐II) were eligible for final assessment. The cumulative incidence of a flank bulge was significantly higher in the SIMULAC‐II group (51.7%) compared to the SIMULAC‐I group [34.4%; odds ratio (OR) 2.04, 95% confidence interval (CI) 1.11–3.73; P = 0.02]. Rate of severe postoperative complications (4.4% SIMULAC‐I vs 10.3% SIMULAC‐II; P = 0.21) or hernia (6.7% SIMULAC‐I vs 10.3% SIMULAC‐II; P = 0.59) was similar between the groups. There was no difference in pain (visual analogue scale) and the requirement for pain medication at 6 months postoperatively. Quality of life assessed with the European Quality of Life 5 Dimensions Questionnaire was higher in the SIMULAC‐I group compared to the SIMULAC‐II group at 6 months postoperatively, with a (median range) score of 80 (30–100) vs 75 (5–100) ( P = 0.012). Conclusion The overall risk of a flank bulge after flank incision is high. Multiple‐layer closure after flank incision should be performed as a standard procedure.