RETRACTED ARTICLE: The value of subcutaneous tissue closure and drain in obese women undergo elective caesarean section: a randomized controlled trial
摘要
to compare the efficacy and safety of subcutaneous suturereapproximation alone versus suture plus subcutaneous drain or non-closure forthe prevention of wound complications in obese women undergoing electivecesarean delivery (CD).
MethodsThis randomized controlled open label trial was conducted on 352obese women candidates for elective CD. Participants were randomized into 4groups: group I (n = 89) were allocated forinterrupted closure of subcutaneous tissue with insertion of subrectus drain,group II (n = 88) were allocated forinterrupted closure of subcutaneous tissue, group III (n = 88) were allocated for insertion of subrectus drain, groupIV (n = 87) were allocated for non-closure ofsubcutaneous tissue without insertion of subrectus drain The primary outcomeparameter was the development of wound complications including seroma, infectionand dehiscence. Secondary outcome included postoperative pain assessed by VAS,postoperative fever, time of hospital stay and duration of surgery.
ResultsThere were significant differences between the 4 groups regardingthe mean duration of surgery (48.67 ± 2.84, 46.56 ± 4.80, 45.95 ± 4.29, and41.59 ± 5.08 in combined, sutures only, drain only and none groups,respectively, P < 0.001).
Assessment of outcome parameters revealed significant differencesbetween the 4 groups regarding postoperative pain (2.93 ± 1.95, 3.62 ± 2.26,3.83 ± 2.16, and 3.99 ± 2.032, P = 0.006),postoperative fever (3/68 (3.5%),5/86 (5.8%),3/68 (3.5%),, and 12/86 (14%),P = 0.017) wound infection (4/68(4.7%),7/86 (8.1%),4/68 (4.7%),, and 13/86 (15.1%), P = 0.035) and wound dehiscence (4/68 (4.7%),6/86 (7%),8/68(9.3%),, and 16/86 (18.6%), P = 0.011) andhighly statistical significant differences regarding wound seroma (4/68(4.7%),13/86 (15.1%),6/68 (7%),, and 21/86 (24.4%), P < 0.001) and redressing(10/68 (11.6%),17/86 (19.8%),19/68(22.1%), and 32/86 (37.2%), P < 0.001) 08in combined, sutures only, drain only and none groups, respectively.
ConclusionThe additional use of a subcutaneous drain along with a standardsubcutaneous suture reapproximation technique is effective for the prevention ofwound complications named seroma, redressing, dehiscence and infection in obesewomen undergoing CD.
Trial RegistrationNCT04177381 Date of registration: 21/11/2019.