None listed
Conditions
Brief summary
After approval from Ethical committee of our hospital, 60 patients presenting in the Department of Plastic Surgery through outpatient department of Jinnah hospital, fulfilling the selection criteria will be included in the study. An informed consent will be obtained from them. Patients will be divided randomly in two groups by random number table; Group A, for micro needling with prp and group B, for micro needling with vitamin C. All the patients will be photographed and baseline assessment will be done before initiation of treatment by filling the proforma attached. All patients will receive a topical local anesthetics 5% EMLA cream for about 45min before procedure.PRP is obtained from patient’s own blood and activated by adding calcium gluconate as 1 ml in 9ml PRP. In both groups patients, micro needling is done in vertical, horizontal and both diagonal directions for 4 times at a depth of 1.5mm, then PRP is injected in group A patients while vitamin C is injected in group B patients and micro needling is repeated again as above. Ice packs will be applied over treated areas in both groups and strict photo protective measures are advised during course of treatment for all the patients. A total of 3 similar sessions will be done at intervals of 4 weeks each. The scars will be assessed by 4 weeks after the end of these treatment sessions using Goodman and baron grading score . Photographs of pre and post treatment faces will be taken under consistent background, position and lighting for comparison. Effect modifiers like age, gender and duration of scar will be addressed through stratification. Data will be entered in the proforma .
Interventions
topical local anesthetic (5% EMLA cream) is applied over scars 45 mins before procedure. Autologous PRP is prepared during this time interval ( of EMLA application) before starting microneedling, All the procedures will performed by primary researcher. Micro needling is done on each scarred skin in vertical, horizontal and both diagonal directions for 4 times (standard application) at a depth of 1.5mm, then PRP is injected at 0.1 ml/cm2 (approximate dose) in group A patients while vitamin C(500m
topical local anesthetic (5% EMLA cream) is applied over scars 45 mins before procedure. Autologous PRP is prepared during this time interval ( of EMLA application) before starting microneedling, All the procedures will performed by primary researcher. Micro needling is done on each scarred skin in vertical, horizontal and both diagonal directions for 4 times (standard application) at a depth of 1.5mm, then PRP is injected at 0.1 ml/cm2 (approximate dose) in group A patients while vitamin C(500mg) 0.1 ml/cm2 is injected over the scarred areas in group B patients and micro needling is repeated again as above. PRP is made by taking 20ml of blood through venous puncture, first soft spin is at 1500 resolutions/min(RPM) for 10 minutes and then second hard spin is at 2500RPM for 10 minutes. from this 20ml we get 4.5ml of PRP Ice packs will be applied over treated areas in both groups and strict photo protective measures are advised during course of treatment for all the patients. Total of 3 sessions 4 weeks apart are done in all the cases. time duration of each session is one hour and thirty minutes primary researcher is post graduate resident in plastic surgery department of Jinnah burn and reconstructive surgery center. PRP is injected at 0.1 ml/cm2 in group A patients while vitamin C 0.1 ml/cm2 is injected over the scarred areas in group B patients both before and after microneedling.. strength of vitamin C injection used is 500mg a total of 4.5ml of prp is obtained from 20ml of blood.
Sponsors
Sania Ahmad
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
10 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Age above 10 years to 50 year/either sex 2. Goodman and baron II, III,IV scars. 3. Atrophic Scars more than 1 year 4. Post burn, trauma, surgery and acne atrophic scars over face
Exclusion criteria
1. Presence of active skin infections like acne, warts, herpes and bacterial infections (determined by history and clinical examination). 2. Keloid scarring/tendency (determined by history and clinical examination). 3. History of bleeding disorder and anticoagulant therapy determined on PT > 10 – 13 sec and INR > 0.9 - 1.2 sec 4. Oral steroid therapy determined on history. 5. Pregnant/lactating women or planning pregnancy will be determined on history
Outcome results
None listed