Comparison of Leukosan SkinLink with surgical suture for traumatic laceration repair: A randomized controlled trial.
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SUBMITTER: Kim H
PROVIDER: S-EPMC6023685 | biostudies-literature | 2018 Jun
REPOSITORIES: biostudies-literature
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Comparison of Leukosan SkinLink with surgical suture for traumatic laceration repair: A randomized controlled trial.
Kim Hyeongtae H Kim Wonhee W Kang Gu Hyun GH Jang Yong Soo YS Choi Hyun Young HY Kim Jae Guk JG Kim In Young IY Kim Minji M
Medicine 20180601 25
<h4>Background</h4>Leukosan SkinLink (LS), which combines non-woven textile strips and tissue adhesive, offers the advantage of atraumatic treatment while effectively shortening the procedure time. We hypothesized that wound closure would be faster with LS than with surgical suture (SS) and the wound infection and dehiscence would be similar.<h4>Methods</h4>A prospective, open label, single-center, randomized controlled trial was performed. Between November 2014 and April 2016, 49 patients with ...[more]
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Project description:ObjectiveTo compare the risk of cesarean wound disruption or infection after closure with surgical staples compared with subcuticular suture.MethodsWomen with viable pregnancies at 24 weeks of gestation or greater undergoing scheduled or unscheduled cesarean delivery were randomized to wound closure with surgical staples or absorbable suture. Staples were removed at postoperative days 3-4 for low transverse incisions and days 7-10 for vertical incisions. Standardized wound evaluations were performed at discharge (days 3-4) and 4-6 weeks postoperatively. The primary outcome was a composite of wound disruption or infection within 4-6 weeks. Secondary outcomes included operative time, highest pain score on analog scale, cosmesis score, and patient scar satisfaction score. Analyses were by intent to treat.ResultsOf 398 patients, 198 were randomized to staples and 200 to suture (but four received staples). Baseline characteristics including body mass index, prior cesarean delivery, labor, and type of skin incision were similar by group. The primary outcome incidence at hospital discharge was 7.1% for staples and 0.5% for suture (P<.001, relative risk 14.1, 95% confidence interval [CI] 1.9-106). Of 350 (87.9%) with follow-up at 4-6 weeks, the cumulative risk of the primary outcome at 4-6 weeks was 14.5% for staples and 5.9% for suture (P=.008, relative risk 2.5, 95% CI 1.2-5.0). Operative time was longer with suture closure (median time of 58 versus 48 minutes; P<.001). Pain scores at 72-96 hours and at 6 weeks, cosmesis score, and patient satisfaction score did not differ by group.ConclusionStaples closure compared with suture is associated with significantly increased composite wound morbidity after cesarean delivery.Clinical trial registration: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01008449.Level of evidence: I.
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Project description:BackgroundIntracranial hemorrhage occurs in over 60% of severe head injuries in one of three types: extradural (EDH); subdural (SDH); and intraparenchymal (TICH). Prompt surgical removal of significant SDH and EDH is established and widely accepted. However, TICH is more common and is found in more than 40% of severe head injuries. It is associated with a worse outcome but the role for surgical removal remains undefined. Surgical practice in the treatment of TICHs differs widely around the world. The aim of early surgery in TICH removal is to prevent secondary brain injury. There have been trials of surgery for spontaneous ICH (including the STICH II trial), but none so far of surgery for TICH.Methods/designThe UK National Institutes of Health Research has funded STITCH(Trauma) to determine whether a policy of early surgery in patients with TICH improves outcome compared to a policy of initial conservative treatment. It will include a health economics component and carry out a subgroup analysis of patients undergoing invasive monitoring. This is an international multicenter pragmatic randomized controlled trial.Patients are eligible if: they are within 48 h of injury; they have evidence of TICH on CT scan with a confluent volume of attenuation significantly raised above that of the background white and grey matter that has a total volume >10 mL; and their treating neurosurgeon is in equipoise.Patients will be ineligible if they have: a significant surface hematoma (EDH or SDH) requiring surgery; a hemorrhage/contusion located in the cerebellum; three or more separate hematomas fulfilling inclusion criteria; or severe pre-existing physical or mental disability or severe co-morbidity which would lead to poor outcome even if the patient made a full recovery from the head injury.Patients will be randomized via an independent service. Patients randomized to surgery receive surgery within 12 h. Both groups will be monitored according to standard neurosurgical practice. All patients have a CT scan at 5 days (+/-2 days) to assess changes in hematoma size. Follow-up is by postal questionnaire at 6 and 12 months. The recruitment target is 840 patients.Trial registrationCurrent Controlled Trials ISRCTN19321911.
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Project description:To assess the efficacy of oral ketamine versus oral midazolam for sedation during laceration repair at a pediatric emergency department.Children between 1 and 10 years requiring laceration repair were randomly assigned to 2 groups, treated either with oral midazolam (0.7?mg/kg) or with oral ketamine (5?mg/kg).Main outcomes measured were level of pain during local anesthesia, as assessed by the parent on a 10-cm visual analog scale (VAS) and the number of children who required intravenous sedation. Secondary outcomes included VAS by physician, pain assessment by child, maximal sedation depth assessed by the University of Michigan Sedation Scale, time until University of Michigan Sedation Scale 2 or more, general satisfaction of a parent and treating physician, length of procedure, total sedation time, and the incidence of any adverse events.Sixty-eight children were recruited of which 33 were girls. Average age was 5.08?±?2.14 years. Thirty-seven children were treated with ketamine and 31 with midazolam. Parent-assessed VAS in ketamine treated patients was 5.07?±?0.75 compared with 3.68?±?0.7 in midazolam treated patients [mean difference = 1.39 95% confidence interval (CI) -0.47 to 3.26]. Twelve (32%) of the children treated with ketamine required the addition of IV sedation compared to only 2 children (6%) of the children treated with midazolam [odds ratio (adjusted for age and gender) 6.1, 95% CI: 1.2 to 30.5]. The rest of the measured variables were similar between the groups, with no statistical significance.No difference in the level of pain was found between ketamine and midazolam treated patients. Compared with oral midazolam (0.7?mg/kg), oral ketamine (5?mg/kg) was associated with higher rates of sedation failure, and thus is not recommended as a single agent for oral sedation in children requiring laceration repair.
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Project description:BackgroundTo compare the early clinical outcomes and Magnetic Resonance Imaging (MRI) results of Delta Medical's PEEK (polyether ether ketone) suture anchor with those of Smith & Nephew's PEEK suture anchor in patients with arthroscopic rotator cuff repair.MethodsA total of 106 patients in four different medical centers were randomly allocated into two groups: Delta Medical's PEEK suture anchor (53 patients); Smith & Nephew's PEEK suture anchor (53 patients). The MRI results and early clinical outcomes were evaluated at 3 and 6 months postoperatively. The University of California at Los Angeles (UCLA) shoulder rating scale and the visual analog scale (VAS) score for pain and range of motion were evaluated. MRI were performed at 3 and 6 months postoperatively to examine the integrity of the repaired rotator cuff tendon based on the Sugaya classification.ResultsSignificant improvements in pain relief, shoulder function, and functional scores were observed in both groups after surgery regardless of the suture anchor applied (P<0.001). No differences observed in the functional scores and range of motion. The assessments of UCLA scores at 3 and 6 months produced no statistical differences (P=0.885 and 0.340, respectively). The mean VAS scores in group 1 did not reveal statistical differences at 3 and 6 months after surgery compared to group 2. No significant differences in the range of motion were found at each follow-up time-point and no shifting or breakage of the anchors occurred between the two groups (P>0.01). No major intra- or post-operative complications, such as infection, and vessel or nerve injury.ConclusionsPain relief and shoulder function were improved after complete rotator cuff repair in both groups, regardless of the suture anchor applied. The difference in functional scores and range of motion were not significant in groups 1 and 2. Delta Medical's PEEK suture anchor had a non-inferiority effect compared to Smith & Nephew's PEEK suture anchor. Delta Medical's PEEK suture anchor was suitable for arthroscopic rotator cuff repair.Trial registrationChinese Clinical Trial Registry, identifier: ChiCTR2100051716.
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Project description:BackgroundAdjustable sutures increase the success rate of strabismus surgery. However, the optimal timing of postoperative suture adjustment remains controversial. This trial was aimed at comparing the surgical outcomes and pain scores of early or 2 - 4 h and delayed or 24 h postoperative suture adjustment in adult patients undergoing strabismus surgery.MethodsAn open-label, prospective, randomized, comparative interventional study was performed in consecutive adult patients scheduled for eye muscle surgery. Patients were randomized into two groups: the early group, with suture adjustment 2 - 4 h postoperatively, and the delayed group, with suture adjustment 24 h postoperatively. Subjective pain scores during the adjustment were also analyzed. The angles of misalignment at 1 and 3 months and the success rate at 3 months postoperatively were compared.ResultsForty-five (90%) patients completed the follow-up, including 23 (92%) in the early adjustment group and 22 (88%) in the delayed adjustment group, with a mean (standard deviation) age of 25.6 (9.5) years and a male-to-female ratio of 46.7:53.3. Thirty patients (66.7%) had exotropia, and 15 (33.3%) patients had esotropia. Both groups had comparable baseline characteristics (all P > 0.05). The mean pain scores during adjustment did not differ significantly between groups (P > 0.05). The postoperative angles of alignment were comparable between the groups before suture adjustment and at the 1- and 3-month follow-ups (all P > 0.05). The success rate in the early adjustment group was slightly higher (87.0% versus 63.6%), but the difference was not statistically significant (P > 0.05). The success rate was comparable between the groups in patients with esotropia or exotropia (both P > 0.05).ConclusionsAlthough the early adjustment group had a slightly higher success rate, the difference was not significant. Both groups had comparable subjective pain scores during adjustment, final motor alignment, or success rate. Future clinical trials should be performed different time intervals for postoperative suture adjustment, and subjective and objective outcomes, such as diplopia and stereopsis, should be compared between patients with a first strabismus surgery and those who underwent reoperation. This could better resolve the persistent controversy related to the optimal time for suture adjustment.
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Project description:OBJECTIVE:This study used a randomized controlled trial (RCT) to evaluate whether mattress suture of pancreatic parenchyma and the seromuscular layer of jejunum (modified Blumgart method) during pancreaticojejunostomy (PJ) decreases the incidence of clinically relevant postoperative pancreatic fistula (POPF) after pancreaticoduodenectomy (PD). BACKGROUND:Several studies reported that mattress suture of Blumgart anastomosis in PJ could reduce POPF rate. This, however, is the first RCT. METHODS:Between June, 2013 and May, 2017, 224 patients scheduled for PD were enrolled in this study in Wakayama Medical University Hospital. Enrolled patients were randomized to either interrupted suture or modified Blumgart mattress suture. The primary endpoint was the incidence of grade B/C POPF based on the International Study Group on Pancreatic Fistula criteria. This RCT was registered with ClinicalTrials.gov (NCT01898780). RESULTS:Patients were randomized to either interrupted suture (103 patients) or modified Blumgart mattress suture (107 patients) and were analyzed by intention-to-treat. Grade B/C POPF occurred in 7 patients (6.8%) in the interrupted suture group and 11 (10.3%) in the mattress suture group (P = 0.367). Mortality within 90 days was 0 in both groups. There were no significant differences in all postoperative complications between the interrupted suture group and the modified Blumgart mattress suture group. CONCLUSIONS:Mattress suture of pancreatic parenchyma and the jejunal seromuscular layer during PJ (modified Blumgart technique) did not reduce clinically relevant POPF compared with interrupted suture.
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Project description:BackgroundInflammatory reaction can produce several complications after cardiac surgery. Many attempts have been made to reduce these complications; perioperative corticosteroid therapy is one of the simplest methods.ObjectivesWe conducted a randomized study to evaluate the efficacy of single dose methylprednisolone, prescribed after surgery, for reducing the complications. Repair of Tetralogy of Fallot was chosen as a homogenous large group for the study.Patients and methodsOne hundred children who underwent total repair of Tetralogy of Fallot were enrolled in this study. After the surgery, all patients were transferred to pediatric ICU and were randomized (in a double-blind fashion) in 2 groups (A and B); a single dose of methylprednisolone (30 mg/kg of body weight) was injected to participants of group "A" just at the time of ICU entrance. Group "B" received no drug. Then, clinical outcomes and laboratory data were compared between the two groups.ResultsThe only significant differences were lower incidence of bacteremia and higher incidence of hyperglycemia in the group who were used methylprednisolone.ConclusionsUsing a single postsurgical dose of methylprednisolone does not significantly alter the clinical outcome after repairing Tetralogy of Fallot.
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