scholarly journals A novel self-assembling peptide for hemostasis during endoscopic submucosal dissection: a randomized controlled trial

Endoscopy ◽  
2020 ◽  
Vol 53 (01) ◽  
pp. 27-35
Author(s):  
Sharmila Subramaniam ◽  
Kesavan Kandiah ◽  
Fergus Chedgy ◽  
Carole Fogg ◽  
Sreedhari Thayalasekaran ◽  
...  
Keyword(s):  
Wound Healing ◽  
Randomized Controlled Trial ◽  
Endoscopic Submucosal Dissection ◽  
Controlled Trial ◽  
Control Group ◽  
Bleeding Rate ◽  
Delayed Bleeding ◽  
Randomized Controlled ◽  
Heat Therapy ◽  
Interventional Group

Abstract Background Endoscopic submucosal dissection (ESD) is associated with a risk of bleeding. Bleeding is usually treated with diathermy, although this does carry a risk of mucosal thermal injury. Purastat is a topical hemostat that may be effective in controlling bleeding during ESD, thereby reducing the use of heat therapy. The aim of this study was to assess the reduction in heat therapy used in the interventional group (Purastat) compared with the control group. The secondary aims were to compare the procedure length, time for hemostasis, delayed bleeding rate, adverse events, and wound healing between the groups. Methods This was a single-center randomized controlled trial of 101 patients undergoing ESD. Participants were randomized to a control group where diathermy was used to control bleeding or an interventional group where Purastat could be used. Follow-up endoscopy was performed at 4 weeks to assess wound healing. Results There was a significant reduction in the use of heat therapy for intraprocedural hemostasis in the interventional group compared with controls (49.3 % vs. 99.6 %, P < 0.001). There were no significant differences in the procedure length, time for hemostasis, and delayed bleeding rate between the groups. Complete wound healing at 4 weeks was noted in 48.8 % of patients in the interventional group compared with 25.0 % of controls (P = 0.02). Conclusions This study has demonstrated that Purastat is an effective hemostat that can reduce the need for heat therapy for bleeding during ESD. It may also have a role in improving post-resection wound healing.

scholarly journals Antioxidant dressing therapy versus standard wound care in chronic wounds (REOX study): Study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Inés María Comino-Sanz ◽  
María Dolores López-Franco ◽  
Begoña Castro ◽  
Pedro Luis Pancorbo-Hidalgo
Keyword(s):  
Wound Healing ◽  
Randomized Controlled Trial ◽  
Wound Dressing ◽  
Chronic Wounds ◽  
Chronic Wound ◽  
Controlled Trial ◽  
Healing Process ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled

Abstract Background: A wound that does not heal in the orderly stages of the healing process or does not heal within three months is considered a chronic wound. Wound healing is impaired when the wound remains in the inflammatory stage for too long. A range of factors can delay the healing process: imbalance between proteases and protease inhibitors in the wound bed; bacterial colonization and the presence of biofilm; and oxidative stress.Recently, wound management has improved significantly. A new antioxidant dressing has been developed, which combines an absorbent matrix obtained from Locust Bean Gum (LBG) galactomannan and a hydration solution with curcumin and N-acetylcysteine (NAC). This dressing combines the advantages of moist healing in exudate management and free radical neutralization, achieving wound reactivation.The primary aim of this study is to compare the effect of antioxidant dressing on chronic wound healing with the use of standard wound dressing in patients with hard-to-heal wounds.Methods: We will conduct a multicentre, single blinded, randomized, controlled trial with parallel groups. Participants will be selected from three primary public health-care centres, located in Andalucía (southern Spain). Patients will be randomized into an intervention group (antioxidant dressing) or control group (standard wound dressing). Assessment will be carried out in weeks 2, 4, 6 and 8. Follow-up will be of 8 weeks or complete healing, if it happens earlier.Discussion: The findings from this study should provide scientific evidence on the efficacy of the antioxidant dressing as an alternative for the treatment of chronic wounds. This study fills some of the gaps in the existing knowledge about patients with hard-to-heal wounds.Trial registration: ClinicalTrials.gov, NCT03934671. Registered on 2 May 2019.

Objective Improvement After Frenotomy for Posterior Tongue-Tie: A Prospective Randomized Trial

2021 ◽  
pp. 019459982110397
Author(s):  
Bobak A. Ghaheri ◽  
Douglas Lincoln ◽  
Tuyet Nhi T. Mai ◽  
Jess C. Mace
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Bottle Feeding ◽  
Control Group ◽  
Feeding System ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial ◽  
Patient Reported ◽  
Interventional Group ◽  
Posterior Tongue

Objective Infants with posterior tongue-tie (PTT) can have substantial difficulty with breastfeeding and bottle-feeding. This study aimed to address the dearth in investigational objective data surrounding PTT release to better quantify the postoperative impacts of frenotomy for ankyloglossia. Study Design Prospective randomized, controlled trial. Setting Private practice clinic. Methods In a prospective, randomized controlled trial, infants 3 to 16 weeks of age with PTT undergoing frenotomy were examined using a bottle-feeding system capable of objectively measuring tongue function. Validated patient-reported outcome measures were also obtained simultaneously. Results Forty-seven infants with PTT were enrolled into an observational/control arm (n = 23) or interventional/surgical treatment arm (n = 24). The total cohort consisted of 29 (61.7%) male infants with a median age of 39 days. At the day 10 time point, the interventional arm demonstrated statistically significant improvement in 11 objectively obtained feeding metrics, indicating faster tongue speed, more rhythmic and coordinated sucking motions, and a tongue more capable of adapting to varying feeding demands. Significant improvement in breastfeeding self-efficacy was reported in the interventional group while poor self-confidence persisted in the observational group. Infant reflux symptoms improved in the interventional group while not in the control group. Nipple pain also persisted in the control group but improved in the surgical cohort. Conclusions When measured 10 days after frenotomy for PTT, infants improve feeding parameters using an objective bottle-feeding system. Similar improvements are seen with patient-reported outcomes when PTT is released. Posterior tongue-tie is a valid clinical concern, and surgical release can improve infant and maternal symptoms.

Endoscopic tissue shielding to prevent bleeding after endoscopic submucosal dissection: a prospective multicenter randomized controlled trial

Endoscopy ◽  
2019 ◽  
Vol 51 (07) ◽  
pp. 619-627 ◽  
Author(s):  
Yosuke Kataoka ◽  
Yosuke Tsuji ◽  
Kingo Hirasawa ◽  
Kengo Takimoto ◽  
Tomonori Wada ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Endoscopic Submucosal Dissection ◽  
Fibrin Glue ◽  
Controlled Trial ◽  
Polyglycolic Acid ◽  
Control Group ◽  
Randomized Controlled ◽  
Submucosal Dissection ◽  
Significant Difference ◽  
Multicenter Randomized Controlled Trial

Abstract Background Bleeding after endoscopic submucosal dissection (ESD) is a severe adverse event. Recent reports have described the efficacy of the endoscopic shielding method with polyglycolic acid (PGA) sheets and fibrin glue for the prevention of adverse events after ESD. The aim of the present study was to investigate whether the PGA shielding method provides additional benefit in preventing post-ESD bleeding compared with standard care. Methods This was a prospective, multicenter, randomized controlled trial. Patients at high risk of post-ESD bleeding were enrolled in the study. Before ESD, patients were randomized to either the PGA group or the control group. After completing ESD in the PGA group, PGA sheets were placed onto the ulcer floor and adhered with fibrin glue. The primary end point was the post-ESD bleeding rate. Results 140 eligible patients were enrolled from September 2014 to September 2016, and 137 were included in the intention-to-treat analysis (67 in the PGA group and 70 in the control group). Post-ESD bleeding occurred in three patients (4.5 %) in the PGA group and in four patients (5.7 %) in the control group; there was no significant difference between the two groups (P > 0.99). Post-ESD bleeding tended to occur later in the control group than in the PGA group (median 12.5 days [range 8 – 14] vs. 2 days [range 0 – 7], respectively). Conclusion The PGA shielding method did not demonstrate a significant effect on the prevention of post-ESD bleeding.

Tualang honey versus steroid impregnated nasal dressing following endoscopic sinus surgery: a randomized controlled trial

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Guhan Kumarasamy ◽  
Ramiza Ramza Ramli ◽  
Harvinder Singh ◽  
Baharudin Abdullah
Keyword(s):  
Wound Healing ◽  
Randomized Controlled Trial ◽  
Surgical Outcomes ◽  
Endoscopic Sinus Surgery ◽  
Controlled Trial ◽  
Sinus Surgery ◽  
Control Group ◽  
Randomized Controlled ◽  
Sinonasal Outcome Test ◽  
Tualang Honey

AbstractObjectivesRecurrence rate of nasal polyps is high following endoscopic sinus surgery. To improve the surgical outcome, steroid impregnated nasal dressing is used postoperatively We aimed to compare the effect of Tualang honey impregnated nasal dressing with steroid impregnated nasal dressing on wound healing and surgical outcomes in post endoscopic sinus surgery patients.MethodsA prospective, randomized, controlled trial was carried out at two tertiary hospitals. 32 patients diagnosed with chronic rhinosinusitis and had underwent endoscopic sinus surgery were enrolled. The study group received 2 mL of Tualang honey nasal dressing and the control group received nasal dressing with 2 mL of triamcinolone 20 mg/mL as positive control. A 2 cm nasal dressing was placed longitudinally into the middle meatuses of both nasal cavities. Postoperative healing assessments of edema, crusting, secretions, scarring and symptoms were performed at postoperative day 7, 14, 28 and at 3 months using Sinonasal Outcome Test 22 questionnaire and modified Lund-Kennedy scoring system.ResultsThere were no significant differences noted in the scores of Sinonasal Outcome Test 22 and modified Lund-Kennedy at Day 7, 14 and 28 (p>0.05) for both groups. At 3rd month, patients in the triamcinolone group had lesser symptoms and better endoscopic findings (p<0.05).ConclusionTualang honey is not as effective as steroid in achieving good wound healing and surgical outcomes in post endoscopic sinus surgery patients. Thus, it is not suitable as a substitute for steroid to reduce symptoms and prevent recurrence of disease.

scholarly journals Antioxidant dressing therapy versus standard wound care in chronic wounds (REOX study): Study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Inés María Comino-Sanz ◽  
María Dolores López-Franco ◽  
Begoña Castro ◽  
Pedro Luis Pancorbo-Hidalgo
Keyword(s):  
Wound Healing ◽  
Randomized Controlled Trial ◽  
Wound Dressing ◽  
Chronic Wounds ◽  
Chronic Wound ◽  
Controlled Trial ◽  
Healing Process ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled

Abstract Background: A wound that does not heal in the orderly stages of the healing process or does not heal within three months is considered a chronic wound. Wound healing is impaired when the wound remains in the inflammatory stage for too long. A range of factors can delay the healing process: imbalance between proteases and protease inhibitors in the wound bed; bacterial colonization and the presence of biofilm; and oxidative stress.Recently, wound management has improved significantly. A new antioxidant dressing has been developed, which combines an absorbent matrix obtained from Locust Bean Gum (LBG) galactomannan and a hydration solution with curcumin and N-acetylcysteine (NAC). This dressing combines the advantages of moist healing in exudate management and free radical neutralization, achieving wound reactivation.The primary aim of this study is to compare the effect of antioxidant dressing on chronic wound healing with the use of standard wound dressing in patients with hard-to-heal wounds.Methods: We will conduct a multicentre, open, randomized, controlled trial with parallel groups. Participants will be selected from three primary public health-care centres, located in Andalucía (southern Spain). Patients will be randomized into an intervention group (antioxidant dressing) or control group (standard wound dressing). Assessment will be carried out in weeks 2, 4, 6 and 8. The follow-up of patients will be prolonged until week 8 or complete healing.Discussion: The findings from this study should provide scientific evidence on the efficacy of 20 the antioxidant dressing as an alternative for the treatment of chronic wounds. This study fills 21 some of the gaps in the existing knowledge about patients with hard-to-heal wounds.

Evaluation of a collaborative protocolized approach by community pharmacies and general medical practitioners for an Australian minor ailments scheme: study protocol for a cluster-randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Sarah Dineen-Griffin ◽  
Victoria Garcia Cardenas ◽  
Kylie Williams ◽  
Shalom Isaac Benrimoj
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Care ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Community Pharmacies ◽  
Randomized Controlled ◽  
Minor Ailments ◽  
Cluster Randomized

BACKGROUND Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MAS) promote efficiencies within the healthcare system. The cost savings and health outcomes demonstrated in the UK and Canada opens up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. OBJECTIVE This trial is evaluating the clinical, economic and humanistic impact of an Australian minor ailments service (AMAS), compared with usual pharmacy care in a cluster-randomized controlled trial in Western Sydney, Australia. METHODS The cluster-randomized controlled trial design has an intervention and a control group, comparing individuals receiving a structured intervention with those receiving usual care for specific common ailments. Participants will be community pharmacies, general practices and patients located in Western Sydney Primary Health Network region. 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients seeking, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments (reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhoea and low back pain). Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The co-primary outcomes are rates of appropriate use of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, time to resolution of symptoms, health services resource utilization and EQ VAS. Differences in the primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost analysis compared with usual care. RESULTS The study began in July 2018. At the time of submission, 30 community pharmacies have been recruited. Pharmacists from the 15 intervention pharmacies have been trained. 27 general practices have consented. Pharmacy patient recruitment began in August 2018 and is ongoing and monthly targets are being met. Recruitment will be completed March 31st, 2019. CONCLUSIONS This study may demonstrate the utilization and efficacy of a protocolized intervention to manage minor ailments in the community, and will assess the clinical, economic and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and self-medication may contribute greater efficiency of healthcare resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a MAS national service, with protocolized care for common ailments using a robust framework for management and referral. CLINICALTRIAL Registered with Australian New Zealand Clinical Trials Registry (ANZCTR) and allocated the ACTRN: ACTRN12618000286246. Registered on 23 February 2018.

Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Community Pharmacies ◽  
Web Based ◽  
Randomized Controlled ◽  
Tailored Interventions ◽  
Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

scholarly journals Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

2019 ◽  
Vol 10 (2) ◽  
pp. 70
Author(s):  
Samah Nasser Abd El-Aziz El-Shora ◽  
Amina Mohamed Rashad El-Nemer
Keyword(s):  
Randomized Controlled Trial ◽  
Cesarean Section ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cost Effective ◽  
Control Group ◽  
Induced Hypotension ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

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