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Both mesh and suture repair are used for the treatment of umbilical hernias, but for smaller umbilical hernias (diameter 1–4 cm) there is little evidence whether mesh repair would be beneficial. In this study we aimed to investigate whether use of a mesh was better in reducing recurrence compared with suture repair for smaller umbilical hernias. We did a randomised, double-blind, controlled multicentre trial in 12 hospitals (nine in the Netherlands, two in Germany, and one in Italy). Eligible participants were adults aged at least 18 years with a primary umbilical hernia of diameter 1–4 cm, and were randomly assigned (1:1) intraoperatively to either suture repair or mesh repair. In the first 3 years of the inclusion period, blocked randomisation (of non-specified size) was achieved by an envelope randomisation system; after this time computer-generated randomisation was introduced. Patients, investigators, and analysts were masked to the allocated treatment, and participants were stratified by hernia size (1–2 cm and >2–4 cm). At study initiation, all surgeons were invited to training sessions to ensure they used the same standardised techniques for suture repair or mesh repair. Patients underwent physical examinations at 2 weeks, and 3, 12, and 24–30 months after the operation. The primary outcome was the rate of recurrences of the umbilical hernia after 24 months assessed in the modified intention-to-treat population by physical examination and, in case of any doubt, abdominal ultrasound. This trial is registered with ClinicalTrials.gov, number NCT00789230. Between June 21, 2006, and April 16, 2014, we randomly assigned 300 patients, 150 to mesh repair and 150 to suture repair. The median follow-up was 25·1 months (IQR 15·5–33·4). After a maximum follow-up of 30 months, there were fewer recurrences in the mesh group than in the suture group (six [4%] in 146 patients vs 17 [12%] in 138 patients; 2-year actuarial estimates of recurrence 3·6% [95% CI 1·4–9·4] vs 11·4% (6·8–18·9); p=0·01, hazard ratio 0·31, 95% CI 0·12–0·80, corresponding to a number needed to treat of 12·8). The most common postoperative complications were seroma (one [<1%] in the suture group vs five [3%] in the mesh group), haematoma (two [1%] vs three [2%]), and wound infection (one [<1%] vs three [2%]). There were no anaesthetic complications or postoperative deaths. This is the first study showing high level evidence for mesh repair in patients with small hernias of diameter 1–4 cm. Hence we suggest mesh repair should be used for operations on all patients with an umbilical hernia of this size. Department of Surgery, Erasmus University Medical Center, Rotterdam, Netherlands.

Objective Timely and complete surgical wound healing substantially affects the patient’s performance and satisfaction with surgery outcomes. Sutures and staples are two common wound closure methods in total knee arthroplasty; however, their role in reducing the rate of surgical wound infections and dehiscence in diabetic patients is unclear. Therefore, this study was conducted to investigate the rate of infection and post-closure dehiscence in wounds closed with either nylon sutures or skin staples in diabetic patients undergoing total knee arthroplasty (TKA). Methods This is a single-blind randomized clinical trial including 70 diabetic mellitus patients undergoing TKA. Patients were selected using a restricted random sampling method and haphazardly assigned to study groups using the permuted block randomization technique, including the suture-closed ( n  = 35) and staple-closed ( n  = 35) groups. The follow-up was 2 to 8 weeks after the surgery, evaluation of wound infection and dehiscence was performed. Results The present study showed that there was no significant correlation between wound infection rate (P-value = 0.254) and wound dehiscence (P-value = 0.324) with the method of wound closure (i.e., sutures or staples). However, surgical wound dehiscence revealed a significant correlation with body mass index (BMI) (P-value = 0.044), Glycosylated hemoglobin (HbA1c) (P-Value = 0.001), and fasting blood glucose (FBS) (P-Value = 0.012) in diabetic mellitus patients. Conclusion The use of the staple technique compared to suture had no difference in the rate of wound opening and infection, but from a clinical point of view, the prevalence of wound opening after TKA in patients with the suture method was higher than that of staples. Further research is needed to confirm these findings and the long-term efficacy of each method. Clinical trial registration The present study was registered at the Iranian Registry of Clinical Trails (No. IRCT20230928059543N1, Trial Id:74754, approved on 12/01/2024, https://irct.behdasht.gov.ir/user/trial/74754/view ) and conducted according to Consolidated Standards of Reporting Trials (CONSORT) guidelines.

PurposeIncisional hernia (IH) has an incidence of 10–23%, which can increase to 38% in specific risk groups. The objective of this study is to report the results at 3 years of follow-up of the use of the reinforced tension line (RTL) technique compared with primary suture only (PSO) closure in the prevention of IH in high-risk patients undergoing laparotomy. MethodsOpen randomized controlled clinical trial. Included were patients older than 18 years who underwent midline laparotomy, emergency or scheduled, who were considered high risk, and who completed 3-year follow-up. The patients were randomized 1:1 to the RTL technique or to PSO. The objective was to report the incidence of IH and the complications associated with the closure method. Intention-to-treat analysis and Cox regression were performed. ResultsA total of 124 patients were randomized; 51 patients from the RTL group and 53 patients from the PSO group finished the 3-year follow-up. The incidence of IH was higher in the PSO group (15/53, 28.3%) than the RTL group (5/51, 9.8%) (p = 0.016, OR 0.35, 95% CI 0.14–0.88, number needed to treat 5.4, log-rank test p = 0.017). The groups were similar in the rates of surgical site infection, hematoma, seroma, and postoperative pain during follow-up.ConclusionsThe RTL technique is useful in the prevention of IH when compared with PSO in high-risk midline laparotomy patients, and it is not associated with a higher percentage of complications.Trial registrationLocal Committee CI-HRAEB-2013-020. March 13, 2013.Clinical trialsNCT02136628, retrospectively registered.

Worldwide, mastectomy for breast cancer is one of the most frequently performed surgical procedures. As one of the main complications of mastectomy, seroma is associated with pain, infections and a prolonged hospital stay. We performed a prospective multicenter randomized trial to assess the efficacy and esthetic outcomes associated with quilting the skin flap. Eighty-seven patients were included. The proportion of patients with seroma on postoperative day 15 was significantly lower in the quilting group (12 out of 39 (30.8%)) than in a control group with conventional wound closure (21 out of 40 (52.5%); P  = 0.05). The mean breast seroma volume was significantly lower in the quilting group (130.2 mL) than in the control group (236.8 mL; P  = 0.02). There were no differences in the esthetic outcomes. The pain level on day 1 was similar in the quilting and control groups (mean visual analog scale score: 2.5 vs. 2.1, respectively; P  = 0.3). Quilting the skin flap was associated with a lower prevalence of seroma and a lower seroma volume, and did not worsen the esthetic outcomes or pain levels. This technique is technically straightforward and should be offered to all patients scheduled for mastectomy.

Background Incisional hernia following abdominal surgery is a frequent complication of midline laparotomy. This complication is strongly associated with the technique and material used for suture. While a monofilament absorbable suture is recommended to prevent incisional hernia, it can lead to suture loosening or surgical-knot breakage. Although barbed sutures can be an alternative suture material in abdominal fascial closure, evidence for its safety and effectiveness is lacking. Therefore, we designed a prospective randomized trial to evaluate the safety and efficacy of absorbable barbed sutures for midline fascia closure in minimally invasive surgery for colorectal and gastric cancers in comparison with conventional absorbable monofilament sutures. Methods A total of 312 patients who underwent minimally invasive surgery for colorectal and gastric cancers will be randomly allocated to either the absorbable barbed or monofilament suture group for abdominal fascia closure in a 1:1 ratio. The primary outcome is incisional hernia rate within 3 years after surgery, as verified by physical examination and computed tomography. Postoperative complications, including surgical site infection, postoperative pain, and quality of life, will be compared between two groups as secondary outcomes. The investigator will examine the patients until discharge and at 6, 12, 18, 24, and 36 months postoperatively. Discussion This is the first randomized controlled trial to compare absorbable barbed sutures with monofilament sutures for midline fascia closure in minimally invasive surgery. If absorbable barbed sutures demonstrate superior results to those of monofilament sutures, this type of suture material may be recommended as an alternative option for abdominal fascia closure. Trial registration KCT0007069. Registered on January 30, 2023

Background Subcuticular suture has proven to reduce superficial incisional SSI (si-SSI) in clean surgery. However, question remains regarding clean-contaminated procedures. The aim of this study is to assess if subcuticular suture is superior to staples in reducing si-SSI incidence in elective HBP surgery. Methods Single-centre, open-label, parallel, pragmatic randomized clinical trial conducted at a referral tertiary Hospital between January 2020 and April 2022. Patients eligible for elective HBP surgery were randomly assigned (1:1) to subcuticular suture or surgical staples wound closure using a minimisation method based on previously confirmed risk factors. The primary endpoint was the incidence of si-SSI. Considered secondary endpoints were major postoperative morbidity in both groups, additional wound complications, median hospital length of stay and need for re-hospitalisation. Results Of the 379 patients, 346 patients were randomly assigned to receive skin closure with staples (n = 173) or subcuticular suture (n = 173). After further exclusion of 11 participants, 167 and 168 patients, respectively in the control and the experimental group received their allocated intervention. For the primary endpoint, no significant differences in si-SSI rate were found: 17 (9.82%) staples group vs. 8 (4.62%) in subcuticular suture group (p = 0.062). Subset analysis confirmed absence of significant differences. As for secondary endpoints, overall wound complications did not differ significantly between two procedures: 19 (10.98%) vs. 10 (6.35%) (p = 0.127). There were no treatment related adverse events. However, occurrence of si-SSI contributed to major postoperative morbidity in both groups (p < 0.001 and p = 0.018) and to a substantially prolonged postoperative hospitalization (p = 0.015). Conclusions Subcuticular suture might offer a relative benefit for skin closure reducing incidence of si-SSI after elective HBP surgery, although this was found not to be clinically relevant. Yet, this should not be interpreted as equivalence among both treatments. Therefore, wound closure strategy should not be based only on these grounds. Trial registration number : ISRCTN Registry number ISRCTN37315612 (registration date: 14/01/2020).

Background Wound infection is a common complication following caesarean section. Factors influencing the risk of infection may include the suture material for skin closure, and closure of the subcutaneous fascia. We assessed the effect of skin closure with absorbable versus non-absorbable suture, and closure versus non-closure of the subcutaneous fascia on risk of wound infection following Caesarean section. Methods Women undergoing caesarean birth at an Adelaide maternity hospital were eligible for recruitment to a randomised trial using a 2 × 2 factorial design. Women were randomised to either closure or non-closure of the subcutaneous fascia and to subcuticular skin closure with an absorbable or non-absorbable suture. Participants were randomised to each of the two interventions into one of 4 possible groups: Group 1 - non-absorbable skin suture and non-closure of the subcutaneous fascia; Group 2 - absorbable skin suture and non-closure of the subcutaneous fascia; Group 3 - non-absorbable skin suture and closure of the subcutaneous fascia; and Group 4 - absorbable skin suture and closure of the subcutaneous fascia. The primary outcomes were reported wound infection and wound haematoma or seroma within the first 30 days after birth. Results A total of 851 women were recruited and randomised, with 849 women included in the analyses (Group 1: 216 women; Group 2: 212 women; Group 3: 212 women; Group 4: 211 women). In women who underwent fascia closure, there was a statistically significant increase in risk of wound infection within 30 days post-operatively for those who had skin closure with an absorbable suture (Group 4), compared with women who had skin closure with a non-absorbable suture (Group 3) (adjusted RR 2.17; 95% CI 1.05, 4.45; p  = 0.035). There was no significant difference in risk of wound infection for absorbable vs non-absorbable sutures in women who did not undergo fascia closure. Conclusion The combination of subcutaneous fascia closure and skin closure with an absorbable suture may be associated with an increased risk of reported wound infection after caesarean section. Trial registration Prospectively registered with the Australian and New Zealand Clinical Trials Registry, number ACTRN12608000143325 , on the 20th March, 2008.

Background Surgical site infections (SSI) remain one of the most common complications in conventional abdominal surgery with an incidence between 4% and 19% (Sandini et al., Medicine (Baltimore) 95:e4057, 2016) in the literature. It is unclear whether the use of coated suture material for skin closure reduces the risk of SSI. In line with in-vitro results, we hypothesize that the use of antibacterial skin sutures (triclosan-coated poliglecaprone 25) reduces the rate of SSI after open abdominal surgery. Methods/design To prevent SSI, triclosan-coated poliglecaprone 25 sutures will be tested against un-coated suture material for skin closure after elective open abdominal surgery of 364 patients. The study is planned as a single-center, prospective randomized controlled trial. Patients will be followed for 30 days after surgery to detect and document wound complications. The rate of SSI after 30 days will be analyzed in both groups. Discussion If we can confirm the proposed hypothesis in our study, this could be a promising and feasible approach to lower SSI after open abdominal surgery. By lowering the rate of SSI this might offer a cost-saving and morbidity-reducing procedure. Trial registration German Clinical Trials Register, DRKS00010047 . Registered on 05.01.2017.

Background Different anastomotic techniques have been evaluated during a laparoscopic Roux-en-Y gastric bypass (RYGB); however, no techniques have proven to be better than any other regarding complications and the percentage of weight loss (excess weight loss (%EWL)), and there are few controlled prospective studies to compare them. Methods A randomized, prospective study was conducted in 238 patients undergoing RYGB for morbid obesity between July 2008 and September 2012 to compare the early and late postoperative complications between the two surgical techniques: gastrojejunal hand-sutured anastomosis (HSA) and circular-stapled anastomosis (CSA). Minimum follow-up was 24 months. Results The two groups of patients were similar for demographic data and preoperative comorbidities. There were no significant differences between the surgical techniques regarding %EWL at 3, 12, and 24 months. The patients with CSA had a greater frequency of postoperative gastrointestinal bleeding (GIB) (4.2 vs. 0 %, p  = 0.024) and surgical wound infection (11.1 vs. 3.4 %, p  = 0.025) than the patients with HSA, with no significant differences in the other early complications. There were no significant differences in either group for late complications (gastrojejunal anastomosis (GJA) stricture, marginal ulcer, GJA perforation, bowel obstruction, and eventration). No significant differences were observed in operative time, rate of reoperation and postoperative length of hospital stay. Conclusions HSA and CSA were techniques with similar safety and effectiveness in our study. HSA had a lower rate of bleeding complications and surgical wound infection, although it does require greater experience in laparoscopic hand suturing.

IntroductionPostoperative wound seroma is common after mastectomy. This complication is associated with significant impact on patient outcomes and healthcare costs. The optimal closure approach for seroma prevention remains unknown but some evidence suggests that quilting suture of the dead space could lower the incidence of seroma. The aim of this trial is to compare seroma formation using quilting suture versus conventional closure with drainage in patients undergoing mastectomy.Methods and analysisThis is a multicentre, superiority, randomised controlled trial in women undergoing mastectomy with or without axillary involvement. Exclusion criteria include indication of bilateral mastectomy or immediate reconstruction and any physical or psychiatric condition that could impair patient's ability to cooperate with postoperative data collection or that do not allow an informed consent. 320 participants will be randomised in a 1:1 ratio to receive either quilting suture or conventional wound closure with drain. The primary outcome is seroma requiring either aspiration or surgical intervention within 21 days following mastectomy. Secondary outcomes include seroma regardless of whether or not it requires an intervention, surgical site infection, pain score, cosmetic result, patient's quality of life, costs and cost-effectiveness. The primary analysis will be an intention-to treat analysis performed with a χ2 test (or Fisher's exact test).Ethics and disseminationWritten informed consent will be obtained from all participants. This study was approved by Tours Research ethics committee (CPP TOURS—Region Centre—Ouest 1, 2014-R20, 16 December 2014). Study findings will be published in peer-reviewed journals and presented at relevant national and international breast cancer conferences.Trial registration numberNCT02263651.