Does application of honey improve surgical outcome in pilonidal cyst excision with secondary intention healing? A prospective randomized placebo-controlled clinical trial.

BACKGROUND: Pilonidal sinus disease (PSD) is a common chronic inflammatory debilitating illness caused by ingrowth of hair into the skin. Excision and healing by secondary intention is one of the acceptable managements. The post-operative wound care needs frequent and time-consuming follow-ups. Honey is considered to be a traditional remedy for wound healing. The current study aimed at finding if application of honey could improve surgical outcome in pilonidal cyst excision with secondary intention healing. METHODS: This study was designed as a randomized placebo-controlled parallel assignment interventional (clinical trial) study conducted at the surgical ward of Shahid Beheshti Hospital affiliated to the Yasuj University of Medical sciences, Yasuj, Iran, and was consisted of the 48 patients who underwent surgical resection for PSD with secondary intention healing (24 patients in intervention and placebo-controlled groups). The main element of honey medicinal gel was the unheated natural honey of Dena Biosphere Reserve within the Zagros Mountains. Patients' wounds were visited by a surgeon and a nurse on the days 7, 15, 30, 45, 60, and 90 post-operation. The surgical outcomes including the time to complete wound healing, pain intensity, odor, discharge at the site of surgery, use of analgesics, the time of to return to the daily activities, and occurring of any side effects including infection, erythema, and bleeding were all recorded. RESULTS: In intervention group, there was significantly lower wound healing time, the lower time to return to the daily activities, lower mean wound volume at the days of 30, 45, 60, and 90 of the follow-up, higher mean post-operative pain level at the days of 15, 30, 45, 60, and 90 of the follow-up, and more usage of analgesics at the days of 15, 30, 45, and 60 of the follow-up. There was no significant difference between intervention and placebo-controlled groups according to the foul smell and fluid discharge at the site of the operation. There were no side effects and complications in both groups of the study. CONCLUSIONS: Application of honey after resection surgery with secondary wound healing is associated with a better surgical outcome and could eventually decrease healing time and reduce duration of return to normal activities, but could increase post-operation pain and analgesic consumption, and no effect on foul smell and discharge. TRIAL REGISTRATION: The project was found to be in accordance to the ethical principles and the national norms and standards for conducting research in Iran with the approval ID and date of IR.YUMS.REC.1399.088 and 2020.05.30 respectively, and is the result of a residency dissertation to get the specialty in general surgery, which has been registered with the research project number 960508 in the Vice Chancellor for Research and Technology Development of Yasuj University of Medical Sciences, Yasuj, Iran, URL: https://ethics. RESEARCH: ac.ir/EthicsProposalViewEn.php?id=144742.

Green tea intake and its effect on laboratory parameters and disease symptoms in hospitalised patients with Covid 19: a structured protocol for a randomized controlled trial.

OBJECTIVES: The current randomized controlled trial (RCT) will be conducted to assess the effect of green tea intake on disease symptoms and laboratory parameters including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and complete blood count (CBC) in patients with mild-to-moderate Covid-19 infection. TRIAL DESIGN: Randomized, double-blinded, parallel (1:1 ratio) clinical trial exploratory study PARTICIPANTS: We will recruit patients with COVID-19 infection admitted to Yasuj Shahid Jalil Hospital in Yasuj City, Kohgiluyeh and Boyer-Ahmad Province, Iran. Participants' inclusion criteria are as follows: Inclusion Criteria Patients aged ≥18 years COVID-19 diagnosis according to real-time polymerase chain reaction (RT-PCR) Exclusion Criteria Pregnancy or lactation Disseminated intravascular coagulation or any other types of coagulopathy Severe congestive kidney failure Having a history of participating in a clinical trial during the last 30 days INTERVENTION AND COMPARATOR: Intervention: Two capsules containing 450 mg green tea extract along with routine treatment for COVID-19 patients in the intervention group. Two capsules containing placebo plus routine treatment for patients with COVID-19 infection. Capsules will be taken twice a day, after lunch and dinner, for 14 days. MAIN OUTCOMES: Changes in disease symptoms and laboratory parameters including CRP, ESR, and CBC after 14 days of the intervention compared to control group. RANDOMISATION: Eligible patients will be randomly assigned into the intervention or control group in a 1:1 ratio. Randomization will be performed based on 8 permuted blocks with block sizes of 10, and patients in the intervention and control groups will be matched according to sex and age categories. Randomization will be done using computer-generated random numbers ( Randomization.com ) BLINDING (MASKING): The appearance of placebo and green tea capsules will be similar in terms of shape and color, and they will be packed in the same bags that will be prepared by the company. Also, the researcher and all participants will not be aware of the divisions until the end of the study. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): The total sample was determined based on CRP MCID in which high CRP levels were considered >2.6 mg/L. Accordingly, a total sample size of 37 patients for each intervention group was required. TRIAL STATUS: The protocol is Version 1.0, on June 5, 2021. Recruitment will start on July 11, 2021, which is anticipated to be completed by September 21, 2021. TRIAL REGISTRATION: IRCT20150711023153N3 ( https://www.irct.ir/trial/55948 ) retrospectively registered on June 4, 2021 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting was eliminated; this Letter serves as a summary of the key elements of the full protocol.

Growth Indices of Exclusively Breastfed Until 6 Months Age and Formula-Fed Infants in Southwest of Iran.

BACKGROUND: Formula milk is prepared as a nutritional substitution for human breast milk, but because of biologic and constituent differences, it might cause obesity and growth disorders in infants. In this study, we compared the growth pattern of formula-fed and breastfed infants living in Yasuj, southwest of Iran. METHODS: Infants 7-14 months of age in southwest of Iran were classified as exclusively breastfed (n = 200) and formula-fed (n = 200) in their first 6 months of life. Growth velocity and Z-scores of weight for age, length for age, weight for length, and head circumference were estimated using WHO Anthro Plus software (2010) and SPSS Version 19 (SPSS Inc., Chicago, IL, USA) using World Health Organization reference for growth data. RESULTS: The study showed that Z-score of length for age and head circumference for age at the birth were significantly lower in formula-fed group than exclusively breastfed group (P < 0.05), but the Z-score of weight for length did not differ significantly. At the sixth month of age, Z-score of weight for length was significantly higher in formula-fed group (P < 0.05), but Z-score of length for age had no significant difference and Z-score of head circumference was higher in exclusively breastfed group yet (P < 0.05). Growth velocity, prevalence of obesity, wasting, underweight, and stunting did not differ between two groups. CONCLUSIONS: Our findings suggest that formula feeding can lead to greater weight gain and may help the catch up of length, but evidences are not convincing enough to suggest the formula as an obesogenic feeding in the studied area. To make a conclusion, we suggest comparing the privileged and unprivileged areas and controlling for confounding variables including family hygiene and infant feeding practices between formula-fed and breastfed infants.