Subcuticular interrupted versus continuous skin suturing in elective cesarean section in obese women: a randomized controlled trial

Abstract

Objective: To compare the interrupted subcuticular skin closure with continuous one in obese women undergoing cesarean delivery.

Materials and methods: A randomized controlled study conducted on 169 obese women with term uncomplicated singleton pregnancy who underwent elective cesarean delivery. They were randomized to either skin closure through continuous subcuticular sutures using vicryl 3/0 or interrupted subcuticular suturing using vicryl 3/0. The primary outcome parameter was occurrence of wound infection. Secondary outcomes included other skin complications, postoperative pain, operative duration and hospital stay

Results: There was a statistically higher number of cases with wound hematoma (20 vs. 10, p?=?.04), infection (30 vs. 15, p?=?.008) and those who needed reclosure of wound (8 vs. 0, p?=?.004) in the continuous when compared to women in the interrupted subcuticular group, respectively. Healing with secondary intension was significantly higher in women in the continuous subcuticular group (52 vs. 26, respectively, p?<?.001). The number of cases with wound seroma and keloid formation was not statistically different between the two groups (25 vs. 19, p?=?.272 and 12 vs. 5, p?=?.069 in the continuous vs. interrupted groups, respectively). The duration of CS was longer in those who underwent interrupted closure when compared to continuous ones. However, that was statistically insignificant (40.95?+?6.376 vs. 37.05?+?6.455, p?=?0.14).

Conclusions: Most surgical wound complications were reduced if skin closure with continuous subcuticular sutures is replaced with interrupted one.     

Intrauterine cleaning after placental delivery at cesarean section: a randomized controlled trial

Objective: The objective of this study is to evaluate whether omission of intrauterine cleaning increases intraoperative and postoperative complications among women who deliver via cesarean section.

Methods: We randomized 206 women undergoing primary elective cesarean deliveries to intrauterine cleaning or omission of cleaning. Postpartum endomyometritis rates across groups were the primary outcome. We also examined secondary outcomes. To detect a 20% difference in infection rate between the cleaned and the non-cleaned groups (two-tailed [alpha]?=?0.05, [beta]?=?0.2), 103 women were required per group. Analysis was by intention-to-treat.

Results: Two hundred and six were randomized as follows: 103 to intrauterine cleaning and 103 to omission of cleaning after placental delivery. There were no statistically significant differences in the rate of endomyometritis between the two groups (2.0% versus 2.9%, RR =0.60; 95% CI 0.40–1.32). There were no statistically significant differences in postpartum hemorrhage rates (5.8% versus 7.7%, RR 0.75; 95% CI 0.6–1.2), hospital readmission rates (2.9 versus 3.8%, RR 0.75; 95% CI 0.5–1.6), time to return of gastrointestinal function, need for repeat surgery, or quantitated blood loss between the two groups.

Conclusions: Our randomized controlled trial provides evidence suggesting that omission of intrauterine cleaning during cesarean deliveries in women at low risk of infection does not increase intraoperative or postoperative complications.     

Optimal skin antiseptic agents for prevention of surgical site infection in cesarean section: a meta-analysis with trial sequential analysis

Purpose: The best choice of antiseptic agent for skin preparation at cesarean section remains controversial. We performed this meta-analysis to assess whether chlorhexidine (CH)-based skin antisepsis was more effective than povidone iodine (PI)-based antisepsis for the prevention of surgical site infection (SSI) after cesarean section.

Methods: PubMed, EMBASE, and the Cochrane Library were systematically searched to identify English publications that compared chlorhexidine gluconate (CH) as a skin preparation agent with PI in cesarean section. The primary outcome was SSI rate. Review Manager 5.3 was used to analyze the collected data and trial sequential analysis (TSA) Software 0.9 (Cochrane Collaboration, Oxford, UK) beta was applied to estimate whether the overall pooled outcome was conclusive.

Results: Six articles involving 4385 participants were included in this study. The outcomes showed that CH-based skin antisepsis, compared with PI-based antisepsis, was not associated with a decreased overall rate of SSI (risk ratio [RR], 0.74; 95% confidence interval [CI], 0.54–1.02; p?=?.07). TSA indicated that the current available evidence was inconclusive. There were no differences in adverse skin reactions in the two groups.

Conclusions: This study provides evidence that CH-based antisepsis for skin preparation does not show an additional advantage in reducing risk of SSI after cesarean section. However, additional high-quality, randomized clinical trials are needed to confirm these findings.     

Pain management after cesarean: a randomized controlled trial of oxycodone versus intravenous piritramide

Purpose

Primary objective was to assess whether oral analgesia with oxycodone offers superior pain relief after cesareans than patient controlled analgesia (PCA). Secondary outcomes were additional pain medication, time to first mobilization, therapeutic side effects, postoperative restrictions, overall satisfaction and costs.

Materials and methods

Randomized controlled trial at a University Hospital conduct between July 2009 and November 2009. Of the 1,112 patients, 257 met the inclusion criteria and 239 agreed to participate. Patients were randomly assigned to either receive intravenous piritramide PCA (2?mg piritramide/ml 0.9?% saline) or oral oxycodone (20?mg). Pain was assessed on a visual analog pain scale (VAS) at 2, 12, 24, 32, 40, 48 and 72?h after cesarean.

Results

No differences in VAS scores were observed within the general study population. Pain scores of oxycodone versus PCA were comparable at 24?h. Patients randomized to PCA demonstrated increased demand for rescue medication 48?h after cesarean (p?=?0.057). In the PCA group, patients with previous cesarean had increased operative times, a trend towards increased VAS scores after 48?h (p?=?0.081) and increased VAS scores in comparison to patients who did not have cesarean before (p?=?0.044). For this subgroup, no difference was seen in the oxycodone patients (p?=?0.883).

Conclusion

General satisfaction with both treatment regimes was high. The results support the potential use of oral pain regimes and emphasis the importance of a multimodal approach to treat post-cesarean pain. Oral oxycodone is a not expensive, convenient and comparable analgesic to PCA devices with opioids after cesarean. Trial registration at clinicaltrials.gov identifier: NCT 01115101.     

Staples vs subcuticular sutures for skin closure at cesarean delivery: a metaanalysis of randomized controlled trials

Recently published randomized trials examining skin closure technique on postcesarean wound complications have produced conflicting results. We performed a metaanalysis of trials comparing staples and subcuticular sutures for skin closure at cesarean section (CS). Pooled outcome measures were calculated using random effects models. Primary outcomes were rates of wound dehiscence (separation) and a composite wound complication rate. Secondary outcomes were patient satisfaction, operating time, and postoperative pain. A total of 877 women from 5 trials were included. Both wound separation (pooled odds ratio, 4.01; P < .0001) and composite wound complication (pooled odds ratio, 2.11; P = .003) rates were higher with staples. The use of staples reduced operating time (weighted mean difference, -5.05 minutes; P = .021). Data on postoperative pain and patient satisfaction were insufficient for metaanalysis. Our findings suggest a possible benefit with subcuticular sutures compared to skin staples for skin closure at CS. However, the optimal skin closure technique at CS demands further study.     

Effect of skin coverage method following subcuticular suturing on wound infection rates at cesarean delivery*

Objective: The objective of this study was to determine whether the use of cyanoacrylate skin glue following subcuticular skin closure was associated with a decrease in wound outcomes in comparison with subcuticular closure plus Steri-strips at cesarean delivery.

Methods: This was a retrospective cohort study of patients undergoing cesarean delivery at a single center over a two-year period. The primary outcome of wound infection and secondary outcomes of wound separation and composite wound complication rate were assessed throughout the six-week postpartum period.

Results: Of 660 women who met inclusion criteria, 35 (5.3%) experienced a wound infection and 90 (13.6%) experienced a wound separation. The composite wound complication rate was 16.4% (n?=?108). Of the 515 cases with a skin coverage method noted, use of skin glue was associated with a marginal decrease in wound infections (p?=?0.057), as well as a significantly reduced incidence of wound separation (p?=?0.03) and composite wound complications (p?=?0.006).

Conclusion: Cyanoacrylate skin glue may be superior to Steri-strips for wound separation and composite wound complication rates when utilized with subcuticular suture at the time of cesarean delivery and may yield some benefit for prevention of wound infection.     

Barbed sutures versus conventional sutures for uterine closure at cesarean section; a randomized controlled trial

Introduction: The aim of this randomized control trial was to compare the operative data and the early postoperative outcomes of cesarean sections in which the uterine incision was closed with a barbed suture (STRATAFIX? Spiral PDO Knotless Tissue Control Device, SXPD2B405, Ethicon Inc.) with those of cesarean sections in which the uterine incision was closed with a conventional smooth suture (VICRYL^?; Ethicon Inc.).

Materials and methods: One hundred pregnant patients were randomized in a 1:1 ratio to the Stratafix group or the Vicryl group. The uterine incision was closed by two layers of sutures in both groups. In the Vicryl group, the first layer was continuous and the second layer was interrupted. In the Stratafix group, both layers were continuous.

Results: The uterine closure time was significantly lower in the Stratafix group (224?±?46 versus 343?±?75?s, p?p value?=?.009). The mean blood loss during closure of uterine incision and mean hospital stay were lower in the Stratafix group but these differences failed to reach statistical significance.

Conclusion: The use of barbed suture for uterine incision closure at cesarean section is associated with shorter uterine closure time and similar early perioperative complications compared with conventional smooth suture. The difference between both groups in the technique of suturing the second layer of the uterine incision may be the cause of the reduction in the uterine closure time and the need for additional sutures to achieve hemostasis during suturing the uterine incision with a barbed suture. Further, well designed randomized controlled trials should be conducted to investigate the association between the type of suture (barbed or conventional smooth) and remote complications of cesarean section (infertility, pelvic pain, abnormal placentation and rupture uterus).     

Chlorhexidine gluconate versus povidone iodine at cesarean delivery: a randomized controlled trial

Background/Aims: To compare the prevalence of positive bacterial cultures at the cesarean delivery (CD) incision site in patients with pre-operative application of chlorhexidine gluconate (CG) versus povidone iodine (PI).

Methods: Women undergoing a scheduled CD at ≥36 gestational weeks were randomly assigned to receive CG or PI. A swab of the incision site was performed at 3?min after disinfectant application and at 18 post-operative hours, and the prevalence of cultures with any detected bacterial growth was compared for the two groups.

Results: Of the 60 participants, 33 (55.0%) were in the PI group. There were no differences detected at 3?min, with 9.1% positive in the PI group versus 0% positive in the CG group (p?=?0.2499). However, at 18?h, women in the PI group were seven times more likely than women in the CG group to have a positive culture (16/33 [48.5%] versus 3/27 [11.1%], OR?=?7.53 [95% CI 1.67–38.83], p?=?0.0023). Multivariate logistic regression demonstrated similar results: OR?=?7.33 (95% CI 1.77–30.35), p?=?0.0060.

Conclusion: The prevalence of positive bacterial cultures obtained at the site of the skin incision 18?h after CD was higher in the PI versus the CG group.     

The modified Misgav-Ladach versus the Pfannenstiel-Kerr technique for cesarean section: a randomized trial

BACKGROUND: Modifications to the classic cesarean section technique described by Pfannenstiel and Kerr have been proposed in the last few years. The objective of this trial was to compare intraoperative and short-term postoperative outcomes between the Pfannenstiel-Kerr and the modified Misgav-Ladach (MML) techniques for cesarean section. METHODS: This prospective randomized trial involved 162 patients undergoing transverse lower uterine segment cesarean section. Patients were allocated to one of the two arms: 88 to the MML technique and 74 to the Pfannenstiel-Kerr technique. Main outcome measures were defined as the duration of surgery, analgesic requirements, and bowel restitution by the second postoperative day. Additional outcomes evaluated were febrile morbidity, postoperative antibiotic use, postpartum endometritis, and wound complications. Student's t, Mann-Whitney, and Chi-square tests were used for statistical analysis of the results, and a p < 0.05 was considered as the probability level reflecting significant differences. RESULTS: No differences between groups were noted in the incidence of analgesic requirements, bowel restitution by the second postoperative day, febrile morbidity, antibiotic requirements, endometritis, or wound complications. The MML technique took on average 12 min less to complete (p = 0.001). CONCLUSION: The MML technique is faster to perform and similar in terms of febrile morbidity, time to bowel restitution, or need for postoperative medications. It is likely to be more cost-effective.     

Serum procalcitonin levels in incisional surgical site infections requiring a secondary suture after cesarean sections

Abstract

Purpose: Surgical site infections (SSIs) after cesarean section cause maternal morbidity and economic and emotional burdens on society. Our aim is to measure procalcitonin (PCT) levels in patients who developed incisional SSIs after cesarean section while also comparing PCT concentrations between patients who underwent a secondary suture and who did not require a secondary suture.

Methods: Ninety-four patients who developed incisional SSI after cesarean section were enrolled in our study. At the time of admission, serum PCT, C-reactive protein (CRP), and white blood cell (WBC) counts were measured. The study population was grouped into two, based on the need of a secondary suture and the patients baseline blood tests were compared.

Results: The mean serum CRP level was not significant among the groups; however, the median serum PCT level was significantly higher in patients who required a secondary suture (0.21 vs. 0.05?ng/ml, p?≤?.0001). Serum PCT levels were positively correlated with the length of hospital stay (r?=?0.72, p?=?.0001). Area under the curve (AUC) for PCT in predicting the need of a secondary suture was 0.85 (95% CI: 0.772–0.922) and the cutoff point was 0.142?ng/ml with a sensitivity of 75% and specificity of 97.8% (p?=?.0001).

Conclusion: Serum PCT is a promising marker for both diagnosing and predicting the severity of SSIs after cesarean sections.

Trial registration: ClinicalTrials.gov identifier: NCT03223233.     

Oronasopharyngeal suction versus no suction in normal and term infants delivered by elective cesarean section: a prospective randomized controlled trial

BACKGROUND/AIM: There are controversies about the routine use of oronasopharyngeal suction (ONPS) in healthy infants. This study aimed to compare the effects of oronasopharyngeal suction with those of no suction in normal, term infants delivered by cesarean section. METHODS: 140 term, healthy newborns of uncomplicated pregnancies were prospectively randomized to one of two groups according to the use of ONPS procedure. Differences in oxygen saturation levels, heart rates, and Apgar scores were determined. RESULTS: The mean SaO(2) values through the 2nd and 6th min of life were significantly higher in the no suction group (p < 0.001). The maximum time to reach SaO(2) of > or =92% (6 vs. 11 min) and > or =86% (5 vs. 8 min) saturation were shorter in the no suction group than in the ONPS group. The mean heart rates were consistently and significantly lower in the no suction group during the first 6 min except the second one. All neonates without suction had an Apgar score of 10 at the 5th min, while the mean +/- SD for ONPS group was 9.34 +/- 0.48 (p < 0.001). CONCLUSION: Although findings remained on statistical level and did not lead to clinically adverse outcomes, there is no statistical or physiological basis for oronasopharyngeal suction as a systematic procedure in healthy, term infants delivered by cesarean section.     

A randomized, controlled trial to compare ketorolac tromethamine versus placebo after cesarean section to reduce pain and narcotic usage

Objective

The purpose of this study was to determine whether postcesarean section administration of ketorolac tromethamine reduces pain and narcotic usage.

Study design

A double-blinded randomized, placebo-controlled trial of ketorolac tromethamine was performed. Patients were randomly assigned to receive either ketorolac tromethamine or placebo. Patient-controlled analgesia (PCA) was used for pain control. Visual analog scales (VAS) were administered postoperatively to assess pain levels. Morphine equivalents and attempts were recorded.

Results

There were 22 patients in each arm of the study. There was no significant difference between patient demographics, blood loss, and type of anesthesia. Pain scores were significantly different at 2, 3, 4, 6, 12, and 24 hours by analysis of variance (ANOVA) (P = .033). There was a significant decrease in pain medication usage (P = .008) in the study group.

Conclusion

Ketorolac tromethamine is efficacious in reducing postoperative pain and narcotics usage after cesarean section.     

High-concentration supplemental perioperative oxygen to reduce the incidence of postcesarean surgical site infection: a randomized controlled trial

OBJECTIVE: Most postcesarean infections are caused by anaerobic bacteria. Oxidative killing, an important defense against surgical infections, depends on the oxygen level in contaminated tissue. Among patients undergoing colorectal surgery, perioperative supplemental oxygen decreased infection rates by 50%. We tested the hypothesis that high-concentration inspired oxygen decreases the incidence of surgical site infection in women undergoing cesarean delivery. METHODS: Using a double blind technique, 143 women undergoing cesarean delivery under regional anesthesia after the onset of labor were randomly assigned to receive low- or high-concentration inspired oxygen via nonrebreathing mask during the operation and for 2 hours after. Surgical site infection was defined clinically as administration of antibiotics for postpartum endometritis or wound infection during the initial hospital stay or within 14 days of surgery. Interim statistical analysis was performed after 25% of the planned sample size (143 of 550) accrued using intention-to-treat principle. The stopping rule P value for futility was P>.11 with two planned interim analyses. RESULTS: Postcesarean infection occurred in 17 (25%, 95% confidence interval [CI] 15-35%) of 69 women assigned to high-concentration oxygen compared with 10 (14%, 95% CI 6-22%) of 74 women assigned to low-concentration inspired oxygen (relative risk 1.8, 95% CI 0.9-3.7, P=.13). The P value exceeded the P value for futility, suggesting these differences were unlikely to reach statistical significance with continued recruitment. CONCLUSION: High-concentration perioperative oxygen delivered through a nonrebreathing mask did not decrease the risk of postcesarean surgical site infection.     

Effect of intra-operative glove changing during cesarean section on post-operative complications: a randomized controlled trial

Purpose

To compare the rates of wound-related complications among women undergoing a cesarean section when the surgical team used intra-operative glove changing versus usual care.

Methods

All women undergoing a cesarean section at a single, county hospital were randomized to usual care or intra-operative glove changing prior to abdominal closure. Participants were randomized at the time of decision for cesarean section; surgeons were not blinded to the randomization arm. The primary outcome was any wound-related complication, including wound hematoma, seroma, skin separation of at least 1 cm, wound infection, or other incisional abnormality requiring treatment within 8 weeks of surgery. To detect a reduction in the primary outcome from 17% in the control group to 9% in the intervention group with 80% power, a total of 554 women (277 per group) were required. Secondary outcomes included other infectious complications including endometritis and other superficial or deep soft tissue infections.

Results

From August 2015 to November 2016, 277 women were randomized to usual care and 276 women were randomized to intra-operative glove changing. The two groups were well balanced in terms of demographic data, comorbid conditions and surgical characteristics. Intra-operative glove changing led to a significant decrease in composite wound complications from 13.6% in the control group to 6.4% in the intervention group (p?=?0.008).

Conclusion

Intra-operative glove changing prior to abdominal closure during cesarean section significantly reduced the incidence of post-operative wound complications.

     

Manual removal versus spontaneous delivery of the placenta at cesarean section in developing countries: a randomized controlled trial and review of literature

Purpose: Cesarean section (CS) rates have increased; this is especially concerning in developing countries. The mode of placental delivery contributes to morbidity associated with CS and determines blood loss during CS. We aimed to compare manual removal versus spontaneous delivery of the placenta at CS.

Methods: In a randomized controlled trial, 574 women admitted for primary or repeat elective CS were randomized into two groups. In group A, the placenta was manually removed, whereas in group B, the placenta was left for spontaneous delivery. Blood loss, operative and postoperative data were recorded.

Results: Blood loss was 875.2?±?524.2?ml in group A versus 731.8?±?426.7?ml in group B (p?=?.001), with a significant drop in postoperative HB (p?=?.015) and HCT (p?=?.031). In group A, odds ratios for blood loss (>1000?ml), HB drop (>?4g/dl), postpartum hemorrhage and blood transfusion were 2.581, 2.850, 2.614 and 1.665, respectively. However, the total operative time (p?=?.326), duration of hospital stay (p?=?.916) and intensive care unit (ICU) admission (p?=?.453) were not statistically different between the two groups.

Conclusions: Manual removal of the placenta at CS is associated with a higher risk of blood loss, postpartum hemorrhage and blood transfusion, with no decrease in operative time.