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NCT04781348
Efficacy of Platelet Rich Plasma Injection Plus Fat Grafting as Compared to Fat Grafting Alone on Burn Scar by Using Vancouver Scar Scale
Phase 4 trial testing Platelet Rich Plasma plus fat grafting in Burn in 64 participants. Completed in 31 December 2021.
15 October 2021
Quick facts
| Lead sponsor | Dow University of Health Sciences |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 64 |
| Start date | 1 March 2021 |
| Primary completion | 15 October 2021 |
| Estimated completion | 31 December 2021 |
| Sites | 1 location across Pakistan |
Drugs / interventions tested
- Platelet Rich Plasma plus fat grafting
Conditions studied
- Burn — all drugs for Burn →
Sponsor
Dow University of Health Sciences
Who can join
Adults 18 to 60, any sex, with Burn. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: - Burn injuries always leave behind some permanent marks on the body of a victim. For the treatment of these scars, digital photography along with scar scales instrument are an important instrument for the patient's evaluation and finally for the follow-up of scars. Clinical evaluation of the patient after the use of Platelet concentration that it is a beneficial treatment which affects both on hard and soft tissues healing because of having growth factors deposited in PRP. Therefore, it can be used as an alternative to surgery which promotes safe and natural healing in such patients. Objectives: - 1\. To determine the efficacy of Platelet Rich Plasma plus fat grafting as compared to fat grafting alone on the Vancouver scar scale. Methodology: - An experimental controlled comparison trial study will be done on burn patients, admitted for recovery at the Plastic surgery department, Civil Hospital Karachi after the approval of the scientific committee and Institutional review board of Dow University of Health Sciences, Karachi. The study participants fulfilling the inclusion criteria giving consent will be randomly divided into two groups, one group will receive only fat grafting whereas another group will receive Platelet Rich Plasma plus fat grafting. The sample size of the study will be 52(26 in each group). Both the groups will be followed initially for 15 days of two visits then monthly two visits and finally after 6 months. Assessment of scar with Vancouver Scars Scale (VSS) will be done. The association of the PRP plus fat cells group and control group will be done by applying Chi-square statistical test. P-Value will be set for statistical significance level at \<0.05.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04781348
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Other Dow University of Health Sciences trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04781348 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Dow University of Health Sciences
- Last refreshed: 21 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04781348.
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