6 research outputs found
Epidemiological Profile of Cleft Lip and Palate Patients Attending Tertiary Care Hospital and Medical Research Centre, Belgaum, Karnataka-A Hospital Based Study
Abstract: Cleft Lip and/or Palate (CL±P) is the most common congenital malformation of the face and it
A multi-centric, single-blinded, randomized, parallel-group study to evaluate the effectiveness of nasoalveolar moulding treatment in non-syndromic patients with complete unilateral cleft lip, alveolus and palate (NAMUC study): a study protocol for a randomized controlled trial.
BACKGROUND
Cleft lip and palate (CLP) are among the most common congenital anomaly that affects up to 33,000 newborns in India every year. Nasoalveolar moulding (NAM) is a non-surgical treatment performed between 0 and 6Â months of age to reduce the cleft and improve nasal aesthetics prior to lip surgery. The NAM treatment has been a controversial treatment option with 51% of the cleft teams in Europe, 37% of teams in the USA and 25 of cleft teams in India adopting this methodology. This treatment adds to the already existing high burden of care for these patients. Furthermore, the supporting evidence for this technique is limited with no high-quality long-term clinical trials available on the effectiveness of this treatment.
METHOD
The NAMUC study is an investigator-initiated, multi-centre, single-blinded randomized controlled trial with a parallel group design. The study will compare the effectiveness of NAM treatment provided prior to lip surgery against the no-treatment control group in 274 patients with non-syndromic unilateral complete cleft lip and palate. The primary endpoint of the trial is the nasolabial aesthetics measured using the Asher McDade index at 5Â years of age. The secondary outcomes include dentofacial development, speech, hearing, cost-effectiveness, quality of life, patient perception, feeding and intangible benefits. Randomization will be carried out via central online system and stratified based on cleft width, birth weight and clinical trial site.
DISCUSSION
We expect the results from this study on the effectiveness of treatment with NAM appliance in the long term along with the cost-effectiveness evaluation can eliminate the dilemma and differences in clinical care across the globe.
TRIAL REGISTRATION
ClinicalTrials.gov CTRI/2022/11/047426 (Clinical Trials Registry India). Registered on 18 November 2022. The first patient was recruited on 11 December 2022. CTR India does not pick up on Google search with just the trial number. The following steps have to be carried out to pick up. How to search: ( https://ctri.nic.in/Clinicaltrials/advsearch.php -use the search boxes by entering the following details: Interventional trial > November 2022 > NAMUC)
A comparison of efficacy of autologous platelet-rich plasma and conventional sutures in anchoring split skin graft on wounds
Context: Split thickness skin grafting (STSG) restores cutaneous cover over wounds thus protecting the underlying surface from contamination, fluid loss and stimulates healing. Autologous platelet rich plasma (PRP) provides a large number of platelets and high concentration of growth factors which promote overall uptake of STSG. Aims: The aim of this study was to assess the immediate, subsequent adhesion and final take of STSG with application of PRP over recipient site. Methods and Material: 1 year Randomised Control Trial where 80 wounds of various aetiologies were randomised into intervention group (n=40) which received PRP before placing STSG on recipient site and control group (n=40) in which the graft was fixed in place with sutures alone. Immediate graft adhesion and subsequent graft uptake were compared between the two groups and statistical analysis was done with: SPSS Version 20. Results: Irrespective of aetiology, and size, among a total of 80 wounds 87.5% grafts had adhered by 1st minute of application in the intervention group compared to nil in control group (p0.05) Conclusions: Application of topical PRP facilitates STSG uptake. It decreases operative time by decreasing mobility of graft over the wound bed. Thus, use of PRP improves outcome of split thickness skin graft in wounds of various aetiologies and we recommend use of the same at recipient site of STSG.
CTRI/2021/06/03440