RETRACTED ARTICLE: The value of subcutaneous tissue closure and drain in obese women undergo elective caesarean section: a randomized controlled trial

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OBJECTIVE: to compare the efficacy and safety of subcutaneous suture reapproximation alone versus suture plus subcutaneous drain or non-closure for the prevention of wound complications in obese women undergoing elective cesarean delivery (CD). METHODS: This randomized controlled open label trial was conducted on 352 obese women candidates for elective CD. Participants were randomized into 4 groups: group I (n = 89) were allocated for interrupted closure of subcutaneous tissue with insertion of subrectus drain, group II (n = 88) were allocated for interrupted closure of subcutaneous tissue, group III (n = 88) were allocated for insertion of subrectus drain, group IV (n = 87) were allocated for non-closure of subcutaneous tissue without insertion of subrectus drain The primary outcome parameter was the development of wound complications including seroma, infection and dehiscence. Secondary outcome included postoperative pain assessed by VAS, postoperative fever, time of hospital stay and duration of surgery. RESULTS: There were significant differences between the 4 groups regarding the mean duration of surgery (48.67 ± 2.84, 46.56 ± 4.80, 45.95 ± 4.29, and 41.59 ± 5.08 in combined, sutures only, drain only and none groups, respectively, P < 0.001). Assessment of outcome parameters revealed significant differences between 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) and highly 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) 08 in combined, sutures only, drain only and none groups, respectively. CONCLUSION: The additional use of a subcutaneous drain along with a standard subcutaneous suture reapproximation technique is effective for the prevention of wound complications named seroma, redressing, dehiscence and infection in obese women undergoing CD. TRIAL REGISTRATION: NCT04177381 Date of registration: 21/11/2019.

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