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Book
Effectiveness of 3-Day Prophylactic Negative Pressure Wound Therapy on Closed Abdominal Incisions in the Prevention of Wound Complications: A Randomized Controlled Trial
Objective
To determine the impact of negative pressure wound therapy of closed abdominal incisions on wound complications.
Background
Surgical wound complications including surgical site infection complicating open abdominal operations are a burden on the economy. The outcomes of SSI include prolonged hospital stays, adjuvant treatment delay, and incisional hernias leading to a decrease in the quality of life. Prophylactic negative pressure wound therapy has recently been tried with promising results.
Methods
A randomized controlled trial involving 140 patients post-laparotomy with primary wound closure was divided into 2 groups (70 patients each). For the first group, NPWT dressings were applied for the first 3 days and then conventional dressings for 4 days after. For the second group, conventional dressings were applied for 7 days. Patients were followed up for SSI, seroma, wound dehiscence, and hospital stay.
Results
pNPWT was associated with a significantly lower rate of SSI development compared with gauze dressings (3/70 vs. 17/70) (
p
= 0.001). It also had a significant effect on lowering the incidence of seroma (0/70 vs. 7/70) (
p
= 0.007) and delayed wound healing (0/70 vs. 8/70) (
p
= 0.006) and on decreasing days of hospital stay (2.2 ± 0.6 vs. 3.5 ± 1.8) (
p
<0.00001). No significant difference was observed with regard to hematoma (0/70 vs. 1/70) (
p
= 0.5) or wound dehiscence (0/70 vs. 2/70) (
p
= 0.5). No burst abdomens or NPWT complications were recorded in our study.
Conclusion
Three-day NPWT applied to primarily closed incisions is effective in reducing the incidence of SSI, seroma, and delayed wound healing in abdominal operations compared to conventional gauze dressings.
Journal Article
Risk of infection and wound dehiscence after use of prophylactic antibiotics in episiotomy or second degree tear (REPAIR study): single centre, double blind, placebo controlled randomised trial
AbstractObjectiveTo evaluate the effect of prophylactic antibiotics on the risk of wound complications after episiotomy or second degree tear.DesignSingle centre, double blind, placebo controlled randomised trial.SettingOne university hospital in the Capital Region of Denmark. Participants were enrolled between March and December 2023. All initial clinical consultations were conducted between March 2023 and January 2024, and all long term follow-up consultations were conducted between March and November 2024. This article reports only data from the first consultation.Participants442 women with episiotomies or second degree tears were consecutively recruited at delivery. Exclusion criteria included treatment allergy (or risk of cross reactivity with related antibiotics), antibiotic use within 24 hours of delivery, non-Danish speakers, caesarean section, or episiotomy extension.InterventionA computer generated program randomised participants to either three doses of amoxicillin (500 mg) with clavulanic acid (125 mg) or placebo starting within six hours post partum and repeated at eight hour intervals. Follow-up was conducted four to 14 days post partum. Physicians, the steering committee, and participants were blinded.Main outcome measuresWound complications (primary outcome) and clinically relevant wound complications (secondary outcome).ResultsThe study ended as planned, in December 2024. 433 women completed follow-up and were included in the primary analysis. No significant difference was observed in overall wound complications (antibiotic 47/218, 22%; placebo 62/215, 29%; P=0.10), with a risk difference of −7.2% (95% confidence interval (CI) −15.4% to 0.8%) and a relative risk of 0.75 (0.54 to 1.04). For clinically relevant wound complications, significantly fewer events occurred in the treatment group (19/218, 9% v 36/215, 17%; P=0.01), with a risk difference of −8.0% (95% CI −14.3% to −1.8%) and a relative risk of 0.52 (0.31 to 0.88). For clinically relevant wound complications, the number needed to treat was 12 (95% CI 7 to 56). Exploratory outcomes show that the treatment group reported better self-evaluated health, received fewer additional antibiotic treatments, and had smaller average wound dehiscence among patients with dehiscence. No serious adverse reactions occurred.ConclusionAlthough no significant effect was seen for overall wound complications, prophylactic antibiotics significantly reduced the risk of clinically relevant wound complications in women with episiotomies and second degree tears and should be considered in postpartum care.Trial registrationClinical Trials Information System (euclinicaltrials.eu) 2022-501930-49-00 and ClinicalTrials.gov NCT05830162.
Journal Article
England's hidden reverse : a secret history of the esoteric underground : Coil, Current 93, Nurse With Wound
Based on several years' worth of exclusive interviews and unprecedented access to all three bands' personal archives, 'England's Hidden Reverse' is the first, definitive, biography of Nurse With Wound, Coil and Current 93.
Book
Comparison of surgical wound infection and dehiscence following the use of two methods of nylon sutures and skin staples in staples in diabetic mellitus patients undergoing total knee arthroplasty surgery: a randomized clinical trial study
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.
Journal Article
Negative Pressure Wound Therapy for the Prevention of Surgical Site Infections Using Fascia Closure After EVAR—A Randomized Trial
Background
Surgical site infections (SSI) in the groin after vascular surgery are common. The aim of the study was to evaluate the effect of negative pressure wound therapy (NPWT) on SSI incidence when applied on closed inguinal incisions after endovascular aneurysm repair (EVAR).
Methods
A multicenter randomized controlled trial (RCT). Between November 2013 and December 2020, 377 incisions (336 bilateral and 41 unilateral) from elective EVAR procedures with the primary intent of fascia closure were randomized and included, receiving either NPWT or a standard dressing. In bilateral incisions, each incision randomly received the opposite dressing of the other side, thereby becoming each other’s control. The primary endpoint was SSI incidence at 90 days postoperatively, analyzed on an intention-to-treat basis. Uni and bilaterally operated incisions were analyzed separately, and their respective p-values combined using Fisher’s method for combining
P
-values. Study protocol (NCT01913132).
Results
The SSI incidence at 90 days postoperatively in bilateral incisions was 1.8% (n = 3/168) in the NPWT and 4.8% (n = 8/168) in the standard dressing group, and in unilateral incisions 13.3% (n = 2/15) and 11.5% (n = 3/26), respectively (combined
p
= 0.49). In all SSIs, bacteria were isolated from incisional wound cultures. No additional SSIs were diagnosed between 90 days and 1 year follow-up.
Conclusions
No evidence of difference in SSI incidence was seen in these low-risk inguinal incisions when comparing NPWT with standard dressings after EVAR with the primary intent of fascia closure.
Clinical Trials:
NCT01913132.
Journal Article
Incisional negative pressure wound therapy for the prevention of surgical site complications in Paediatric patients with non‐idiopathic scoliosis: A randomized clinical trial
Surgical wound complications are adverse events with important repercussions for the health of patients and health system. Surgical site infections and wound dehiscences are among the most important surgical wound complications, with a high incidence in paediatric patients undergoing surgery for non‐idiopathic scoliosis. Incisional negative pressure wound therapy for surgical incisions is used as a preventive measure against surgical wound complications in adults; however, there has been scant evidence for using it in children. The purpose of this study is to evaluate the cost‐effectiveness of incisional negative pressure wound therapy in preventing surgical wound complications in paediatric patients undergoing surgery to treat non‐idiopathic scoliosis. Randomized clinical trial. Children younger than 18 years of age undergoing surgery for non‐idiopathic scoliosis were randomly assigned into two groups to receive one of two different types of dressings for the first 7 days after surgery. One group were treated with a postoperative hydrofibre and hydrocolloid dressing with silver for wounds (control group), and the other group received a single‐use incisional negative pressure wound therapy system (intervention group). The wounds were assessed after removal of the dressings at 7 days after surgery and again at 30, 90, and 180 days after surgery. Surgical wound complications, sociodemographic variables, variables related to the procedure and postoperative period, economic costs of treatment of surgical wound complications, and time to healing of the surgical wound were recorded. Per protocol and per intention to treat analysis was made. The per protocol incidence of surgical wound complications was 7.7% in the intervention group versus 38.5% in the control group (p = 0.009; Fisher exact test. RR = 0.20 IC95%: 0.05–0.83). Surgical wound dehiscence, surgical site infections, seroma, and fibrin were the most common surgical wound complications. The type of surgery, duration of surgery, and patients' age were associated with a higher risk for surgical wound complications. Postoperative hydrofibre and hydrocolloid dressing with silver for wounds were found to be associated with a longer time to healing. Initial costs for dressings in the group receiving incisional negative pressure wound therapy were higher, but the total postoperative costs were higher for those receiving postoperative hydrofibre and hydrocolloid dressing with silver for wounds. It was found that for each US $1.00 of extra costs for using incisional negative pressure wound therapy, there was a benefit of US$ 12.93 in relation to the cost of complications prevented. Incisional negative pressure wound therapy is cost‐effective in the prevention of surgical wound complications in children undergoing surgery for non‐idiopathic scoliosis.
Journal Article
Comparison of silver-embedded occlusive dressings and negative pressure wound therapy following total joint arthroplasty in high BMI patients: a randomized controlled trial
IntroductionHigh body mass index (BMI) and wound drainage following total joint arthroplasty (TJA) can lead to wound healing complications and periprosthetic joint infection. Silver-embedded occlusive dressings and negative pressure wound therapy (NPWT) have been shown to reduce these complications. The purpose of this prospective trial was to compare the effect of silver-embedded dressings and NPWT on wound complications in patients with BMI ≥ 35 m/kg2 undergoing TJA.MethodsWe conducted a randomized control trial of patients who had a BMI > 35 m/kg2 and were undergoing primary TJA between October 2017 and February 2020. Patients who underwent revision surgery, or those with an active infection, previous scar, history of wound healing complications, post-traumatic degenerative joint disease with hardware, or inflammatory arthritis were excluded. Patients were randomized to receive either a silver-embedded occlusive dressing (control) or NPWT. Frequency distributions, means, and standard deviations were used to describe patient demographics, postoperative complications, 90-day readmissions, and reoperations. T-test and chi-squared tests were used to test for significant differences between continuous and categorical variables, respectively.ResultsTwo hundred-thirty patients with 3-month follow-up were included. One-hundred-fifteen patients received the control and 115 patients received NPWT. There were six patients (5.2%) in the control group with wound complications (drainage: n = 5, non-healing wound: n = 1) and two patients (1.7%) in the NPWT with complications (drainage: n = 2). There were no 90-day readmissions in the control group versus two (1.8%) 90-day readmissions in the NPWT group. Finally, three patients (2.6%) in the control group underwent reoperations (irrigation and debridement [I&D], I&D with modular implant exchange, and implant revision), while none in the NPWT group had undergone reoperation. The two groups showed insignificant differences in wound complications (p = 0.28), 90-day readmissions (p = 0.50), and reoperations (p = 0.25).ConclusionPatients with BMI ≥ 35 m/kg2 undergoing TJA have no statistical difference in early wound complications, readmissions, or reoperations when treated with either silver-embedded dressings or NPWT.
Journal Article
The MESH-RTL Project for prevention of abdominal wound dehiscence (AWD) in high-risk patients: noninferiority, randomized controlled trial
PurposeTo compare reinforced tension line (RTL) and mesh techniques in the onlay position for preventing abdominal wound dehiscence (AWD) in a noninferiority clinical trial.MethodsPatients > 18 years old who underwent midline laparotomy and who were considered at high risk on the modified Rotterdam risk scale were included. The outcomes analyzed were the incidence of AWD and surgical site occurrence (SSO).Results239 patients were included: 121 mesh group and 118 RTL group. Five (4.1%) of the 121 patients in the mesh group and 7 (5.9%) of the 118 patients in the RTL group presented with AWD (p = 0.56, RR = 0.69, 95% CI = 0.22–2.13) in the per-protocol analysis. The median time of presentation was 6 days. The 95% CI (−0.0567, 0.0231) for the difference in incidence between the two groups was entirely within the predefined noninferiority margin of 5%. The incidence of complications did not significantly differ between the two groups: the mesh group (27, 22.3%) and the RTL group (16, 12.8%) (p = 0.09, RR (95% CI) = 1.64 (0.93–2.89)).ConclusionThe use of the RTL technique for preventing AWD was not inferior to the use of mesh in the onlay position, nor did it increase the risk of complications. This study was registered on clinicaltrials.gov: Mesh-RTL Project (NCT04134455).
Journal Article