The value of honey dressings in pilonidal cyst healing: a prospective randomized single-center trial.

BACKGROUND: Honey is described as a wound healing agent. Many virtues have been attributed to it, in particular, antibacterial properties. The aim of our study was to evaluate its value in healing of wounds after wide excision on pilonidal cyst healing. METHODS: A prospective randomized trial was conducted from March 2016 to February 2022 which included patients with a persistent non healed wound which required packing 6 weeks after pilonidal cyst excision. Patients were randomly allocated to simple alginate wick dressings or the same design plus honey. RESULTS: Fifty patients were included in each arm. There were 57 men and 43 women. The median age was 22 years (range 19-28 years). The mean healing time was 61 (± 44) days in the wick + honey group compared to 78 (± 55) days in the simple alginate wick group (p = 0.094). There was no significant difference between the two groups in terms of time off work and time without physical activity The VQ-Dermato quality of life score was equivalent in both groups. CONCLUSIONS: Tolerability for honey dressings is good and is equivalent to that of alginate dressings in cavity wound care. This trial did not reach a significant difference in its primary endpoint but it shows the value of honey in this indication, although its use requires further study. TRIAL REGISTRATION NUMBER: CLINICAL TRIALS: NCT02485860 and EUDRACT: 2015-A00452-47 (10/03/2015).

Evaluation of a treatment pathway for the management of uncomplicated diverticulitis.

INTRODUCTION: Recent clinical practice recommendations have radically modified the management of colonic diverticulitis. The goal of our study was to evaluate a treatment pathway for uncomplicated diverticulitis and to analyze the outcome (patient compliance, treatment failure and complications). PATIENTS AND METHODS: All patients who presented to the emergency department with the diagnosis of uncomplicated diverticulitis were prospectively included in this study. The treatment pathway included an outpatient clinical re-assessment by a gastrointestinal surgeon. In case of symptomatic treatment failure, oral antibiotics were prescribed. If developed clinical signs of severity developed, the patient was referred to the emergency department for new laboratory and imaging workup. RESULTS: Eighty-seven patients were included. The mean interval before re-assessment was 2.8 days. Fifty-nine patients (67.8%) had symptomatic treatment upon discharge from the emergency department and were reassessed as outpatients by the surgical team. Patient evolution was satisfactory for 45 (76.3%); 10 (16.9%) required oral antibiotics. One (1.7%) patient developed complicated diverticulitis. Thirty-four (39.1%) patients did not comply with the current recommendations. CONCLUSION: In our experience, uncomplicated diverticulitis can be treated effectively in an ambulatory setting followed by early re-assessment by a surgeon.

[Screening and management of endometriosis by primary care physicians]. / Repérage et prise en charge de l'endométriose en soins primaires par les médecins généralistes.

OBJECTIVE: Analyze knowledge and practices of general practitioners concerning the screening and treatment of endometriosis in primary care. METHODS: Observational study carried out with general practitioners in a healthcare area using an anonymous online questionnaire about symptoms, screening and their management of endometriosis. Responses were analyzed according to the general practitioners' sex, age and practice in gynecology. RESULTS: Sixty-nine general practitioners (69/458 ; 15.1%) responded. Women (18.4% vs. 9.7% : P=0.02), between 40 and 59 years old (26.5% vs. 0 ; P<0.01), with additional training in gynecology (27.2% vs. 3.0%; P<0.01) had significant activity in gynecology. Typical symptoms of endometriosis were experienced by 76.8% general practitioners, but only 36% "often" or "always" referred to endometriosis when faced with these symptoms. Additional training in gynecology, mostly carried out by women, between 40 and 59 years old, had a positive impact on the evocation of endometriosis in the face of these symptoms. If endometriosis was suspected, 72.5% GPs immediately ordered pelvic ultrasound and 85.5% for analgesics, but 42% referred the woman to a gynecologist. CONCLUSION: The general practitioner has a key role in the screening and initial management of endometriosis in primary care. The practice and continuing education of general practitioners in gynecology has a significant impact in improving the screening and initial management of endometriosis.

Comparison of patient-led, fibromyalgia-orientated physical activity and a non-specific, standardised 6-month physical activity program on quality of life in individuals with fibromyalgia: a protocol for a randomised controlled trial.

BACKGROUND: Exercise has been shown to significantly improve pain and function in individuals with fibromyalgia. Research into the effectiveness of exercise is often based on standardised exercise programmes that are chosen by the investigating clinical research team. However, such programmes may not necessarily be appealing to the participating patients. Furthermore, in addition to being taught exercises, patients with chronic conditions like fibromyalgia also need to learn to manage their condition themselves and so be actively involved in their treatment. The primary aim of this study is to compare the effects of two, 6-month physical activity programs on quality of life in patients with fibromyalgia. One group followed a patient-led, fibromyalgia-orientated programme (experimental) whilst the control group followed a standard, general exercise programme. METHODS: This protocol is an open-label, two-centre, randomised, controlled superiority trial. Two treatment arms will be compared: an experimental group (patient-led, fibromyalgia-orientated exercise) and a control group (general exercise program). The control group will participate in the exercise programme currently provided in our centre, which involves general, group exercise for patients with various pathologies. The experimental group will be taught the principles of exercise specifically for fibromyalgia during a one-to-one coaching session. They will then be guided in the choice of one or several types of exercise that they enjoy. They will be instructed to perform the exercise according to the recommendations for exercise in fibromyalgia with regard to intensity, duration and frequency. The protocol will last for 6 months; participants will then be followed-up for a further 6 months. They will also be encouraged to continue exercising after the end of the protocol. Outcomes will be evaluated at baseline, 6 and 12 months. The primary outcome will be quality of life (Fibromyalgia Impact Questionnaire) and the secondary outcomes will include measures of pain (including a visual analogue scale and the neuropathic characteristics of the pain), depression (Hospital Anxiety and Depression Scale), kinesiophobia (Tampa scale of kinesiophobia) and adherence (Polar OH1 heart rate monitor). DISCUSSION: The results of this study will show if patient-led, fibromyalgia-orientated exercise is more effective than a general exercise programme on fibromyalgia-related outcomes, including quality of life, and on adherence to continued exercise. TRIAL REGISTRATION: ClinicalTrials.gov NCT03895086 . Registration no. 2018-A02881-54. Registered on 29 March 2019.

Tolerance and effect of sodium thiosulfate in calcific tendinitis of the rotator cuff.

BACKGROUND: Calcific tendinitis of the rotator cuff is one of the most common causes of shoulder pain. Ultrasound-guided percutaneous lavage of calcific tendinopathy is performed when conservative treatments have failed. Sodium thiosulfate (STS) has recently been used with success in the treatment of tumoral calcinosis. The goal of this phase II study was to assess the tolerance and the feasibility of STS lavage of calcific tendinopathy. METHODS: We included patient with type hard calcifications. Patients were treated with puncture and lavage followed by injection of STS in the calcification. VAS pain at rest and during activities, ultrasound, and X-ray were evaluated at 1 week and 1 and 3 months. RESULTS: Seventeen patients were included. Baseline VAS at rest and during daily activities was a mean 40.2 ± 25.9 and 65.5 ± 21.6 respectively. All patients underwent the entire procedure with no adverse event. Calcium backflow could be obtained in 15 patients (88.2%). Five patients (30%) had more than 50% decrease of their calcific deposit size at 1 month and 8 (47%) patients at 3 months. VAS pain during activities and at rest decreased significantly at 3 months (p = 0.0004; p = 0.001). Efficacy would be demonstrated if 60% of the patients had more than 50% decrease size of their calcification CONCLUSION: Overall, STS was well tolerated with no side effect occurring during the procedure and the follow-up. However, no significant effect on calcium disappearance could be demonstrated compared with what is expected without STS. New studies using larger volume and repeated injections of STS are now needed. CLINICAL TRIAL REGISTRATION NUMBER: NCT02538939Key Points• Lavage of calcific tendinopathy of the rotator cuff with sodium thiosulfate is feasible• No adverse events have been observed after or in the 3 months after the procedure• We could not demonstrate that sodium thiosulfate increases the chance of calcium disappearance• New studies using larger volume and repeated injections of STS are needed to further explore the interest of sodium thiosulfate in the treatment of calcific tendinopathy.

Cefazolin tissue concentrations with a prophylactic dose administered before sleeve gastrectomy in obese patients: a single centre study in 116 patients.

BACKGROUND: In obese patients undergoing sleeve gastrectomy, the blood and fatty-tissue concentrations of cefazolin required for adequate antibiotic prophylaxis are uncertain. METHODS: This was a single centre prospective study in obese (Group A: 40≤ BMI ≤50 kg m-2) and severely obese (Group B: 50< BMI ≤65 kg m-2) patients undergoing bariatric surgery. Blood and fatty-tissue samples were collected after a cefazolin 4 g i.v. injection. The primary aim was to compare cefazolin concentrations in subcutaneous fatty tissue with a targeted tissue concentration of 4 µg g-1 according to Staphylococcus aureus resistance breakpoint. RESULTS: One hundred and sixteen patients were included: 79 in Group A and 37 in Group B. At the beginning of the surgery, cefazolin concentration in subcutaneous fatty tissue was 12.2 (5.4) µg g-1 in Group A and 12 (6.1) µg g-1 in Group B (P=0.7). At the end, cefazolin concentrations in subcutaneous fatty tissue were 9.0 (4.9) and 7.8 (4.2) µg g-1 in Groups A and B, respectively (P=0.2). The plasma concentration of free cefazolin during surgery was higher in Group A than in Group B (P<0.0001). Fatty-tissue concentrations of 95% and 83% patients in Groups A and B, respectively, were above S. aureus resistance breakpoint. CONCLUSIONS: After a 4 g dose, the concentrations of cefazolin in fatty tissue were above the 4 µg g-1 tissue concentration target, providing adequate antibiotic tissue concentrations during bariatric surgery. As cefazolin concentration in fatty tissue is a surrogate endpoint, the results should be considered in conjunction with the results on free cefazolin concentrations in subcutaneous tissue. CLINICAL TRIAL REGISTRATION: NCT01537380.

Evaluation of S100B blood level as a biomarker to avoid computed tomography in patients with mild head trauma under antithrombotic medication.

PURPOSE: The goal of this prospective study was to analyze the potential of S100B protein as a negative predictive marker for intracranial hemorrhage (ICH) after mild head trauma (MHT) in patient under antithrombotic medication. METHODS: Patients under antithrombotic medication who had MHT were consecutively included in this study. S100B blood levels were determined from samples drawn within 6hours after injury and were analyzed with the results of head CT performed within the 24hours after injury. Sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) of S100B levels for the detection of ICH, with a cut-off set at 0.105µg/L, were calculated. RESULTS: A total of 308 patients (151 men and 157 women) with a mean age of 79.1±10.5years (SD) were included in the analysis. CT was positive for the presence of ICH in 33 patients (10.7%; 95% CI: 7.5-14.7%). In the study population, S100B showed a sensitivity of 84.8% (95%CI: 68.1-94.9%), a specificity of 30.2% (95% CI: 24.8-36.0%), a NPV of 94.3% (95% CI: 87.2-98.1%), and a PPV of 12.7% (95% CI: 8.6-17.9%) for the diagnosis of ICH. CONCLUSION: The results of this study suggest that a S100B serum level<0.105µg/L has a high NPV for ICH after mild head trauma in patients under antithrombotic medication.

Impact of high-dose chemotherapy followed by auto-SCT for positive interim [18F] FDG-PET diffuse large B-cell lymphoma patients.

[(18)F] fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) is increasingly used for response assessment in diffuse large B-cell lymphoma (DLBCL). A positive interim FDG-PET was shown to be associated with an unfavorable outcome in high-grade non-Hodgkin's lymphomas. For positive interim FDG-PET patients, the question of increasing the intensity of treatment using high-dose chemotherapy followed by auto-SCT (HDC-ASCT) remains unanswered. We retrospectively analyzed the prognostic value of FDG-PET in 42 DLBCL patients who were systematically evaluated at time of diagnosis, before and after HDC-ASCT. Of note, HDC-ASCT was part of the initial treatment strategy, while FDG-PET results did not influence the treatment approach. Results and outcome were analyzed according to FDG-PET results before and after HDC-ASCT. Patients were classified into three groups according to FDG-PET results before and after HDC-ASCT: those who were negative before and after (-/-; n=25), positive before and negative after (+/-; n=9) or positive before and after (+/+; n=8). The median follow-up was 34.5 (range, 19-74) months. The median EFS was significantly lower for the +/+ group (27.4 months) as compared with other groups (median not reached; P=0.0001). More importantly, there was no difference in term of EFS between the -/- group compared with the +/- group. These results suggest that HDC-ASCT can significantly improve the bad prognosis, otherwise indicated by a positive interim FDG-PET.

Colon capsule endoscopy vs. colonoscopy in patients at average or increased risk of colorectal cancer.

BACKGROUND: Colon capsule endoscopy (CCE) is a new, non-invasive technology. AIM: To conduct a prospective, multicentre trial to compare CCE and colonoscopy in asymptomatic subjects enrolled in screening or surveillance programmes for the detection of colorectal neoplasia. METHODS: Patients underwent CCE on day one and colonoscopy (gold standard) on day two. CCE and colonoscopy were performed by independent endoscopists. RESULTS: A total of 545 patients were recruited. CCE was safe and well-tolerated. Colon cleanliness was excellent or good in 52% of cases at CCE. Five patients with cancer were detected by colonoscopy, of whom two were missed by CCE. CCE accuracy for the detection of polyps ≥ 6 mm was 39% (95% CI 30-48) for sensitivity, 88% (95% CI 85-91) for specificity, 47% (95% CI 37-57) for positive predictive value and 85% (95% CI 82-88) for negative predictive value. CCE accuracy was better for the detection of advanced adenoma, in patients with good or excellent cleanliness and after re-interpretation of the CCE videos by an independent expert panel. CONCLUSIONS: Although well-tolerated, CCE cannot replace colonoscopy as a first line investigation for screening and surveillance of patients at risk of cancer. Further studies should pay attention to colonic preparation (Clinicaltrial.gov number NCT00436514).

Human herpes virus 6 infection is a hallmark of cord blood transplant in adults and may participate to delayed engraftment: a comparison with matched unrelated donors as stem cell source.

Occurrence of CMV, EBV and human herpes virus 6 (HHV6) infections and immune reconstitution were compared in 15 adult patients receiving a cord blood transplantation (CBT) and 40 patients who received an allogeneic transplantation from a matched unrelated donor (MUD). Herpes virus DNA quantifications in the blood (459 samples) were performed before and then monthly up to 9 months after transplant and the main lymphocytes populations were counted at 3, 6 and 9 months. Incidence of HHV6 infection was significantly higher in the CBT group (80 vs 42.5%; P<0.0001), with higher viral load (P<0.0001). In multivariate analysis, the use of a CBT and a myeloablative conditioning regimen were found to increase the risk of HHV6 infection (odds ratio (OR)=5.4, P=0.02 and OR=3.5, P=0.04, respectively). Incidences of CMV were similar between the two groups whereas MUD increased the risk of EBV infection, in univariate analysis only. HHV6 reactivation translated toward delayed neutrophils and plts engraftment in the two groups. MUD and CBT do not share the same immune reconstitution patterns, notably for B and CD8 lymphocytes and NK cells. There is a strong and specific relationship between HHV6 infection and the use of cord blood cells.

Cytomegalovirus: its potential role in the development of cutaneous T-cell lymphoma.

To investigate the potential role of CMV in cutaneous T-cell lymphoma (CTCL), we studied cytomegalovirus (CMV) seroprevalence in parapsoriasis (PP), mycosis fungoides (MF) and Sézary syndrome (SS) compared with healthy control patients. In cases where CMV seropositivity was observed, CMV PCR analyses were performed on skin biopsies. CMV seroprevalence was 37.1% in the control group, 50.68% in the PP + MF + SS group (P = 0.08), 56.2% in the MF + SS group (P = 0.07), 40% in the PP group (P = 0.9), 66.67% in the MF group (P = 0.009), 42.86% in the SS group (P = 0.9). CMV PCR in initial skin biopsies were all negative. However, PCR CMV was positive in two SS skin biopsies realized at an advanced stage. Our results show that latent CMV infection may play a role in the susceptibility of MF in predisposed subjects by inducing T-cell proliferation and resistance to apoptosis. Concerning SS, an immunosuppressive state may be responsible for CMV reactivation that in turn may interfere with evolution of the disease.