Subcision With PRP and Microneedling Versus Subcision With Saline and Micro-needling in Treatment of Posttraumatic Scars

Subcision With Platelet-Rich Plasma and Microneedling Versus Subcision With Saline and Micro-needling in Treatment of Posttraumatic Scars: Randomized Clinical Trial

Compare different minimally invasive approaches to reach optimum improvement by comparing the efficacy and safety of both combined subcision with platelet-rich plasma and microneedling versus combined subcision with saline and microneedling in the treatment of post-traumatic scars.

Study Overview

• Status: Completed
• Conditions: Post-Traumatic Scar
• Intervention / Treatment: Other: subcision ,PRP or saline and microneedling

Detailed Description

The scars at the level of the skin represent a normal and inevitable process of healing traumatic or surgical lesions, but except for the appearance of the skin, they also have a profound psychological impact . Thus, people with scars try to integrate them into their sense of self to gain psychological acceptance .

Many treatment options have been developed for the management of traumatic scars .Surgical intervention is an invasive technique, surgery has a high risk of inducing new scar formation .

Non-surgical approaches for the treatment of traumatic scars include topical treatments and minimally invasive approached as subcision,microneedling and laser.

Autologous platelet-rich plasma is plasma with a higher concentration of platelets than normally found, it can enhance wound healing which has been demonstrated in controlled studies for soft and hard tissues . The application of autologous platelet-rich plasma to surgical wounds has been shown to accelerate tissue repair and reduce postoperative pain .

Subcision is a procedure in which a needle is inserted under the skin and passed in multiple directions . Although subcision is adequate as a stand-alone treatment, improved results are achieved when it is combined with other modalities.

Microneedling is a percutaneous collagen induction therapy that causes skin resurfacing. It involves using fine needles to create controlled microdermal injuries starting a complex cascade of growth factors that end in collagen remodeling .

Because of the different treatment options available for this common problem, the current work aimed to combine and compare different minimally invasive approaches to reach optimum improvement.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with posttraumatic scars
• Age more than 12 years

Exclusion Criteria:

• Patients with platelet or blood clotting disorders, and chronic liver or autoimmune diseases.
• Patients with chronic debilitating diseases, uncontrolled systemic infection, or keloid tendency or with unrealistic expectations.
• Pregnant females.
• Patients who did not complete the treatment sessions or the follow-up period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: combined subcision with platelet-rich plasma and microneedling group	Other: subcision ,PRP or saline and microneedling; minimally invasive procedures
Active Comparator: combined subcision with saline and microneedling group	Other: subcision ,PRP or saline and microneedling; minimally invasive procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scar severity grading	Scar severity grading will be evaluated by blinded dermatologist	after 1 month of treatment completion.

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): March 30, 2024

Study Registration Dates

• First Submitted: November 12, 2023
• First Submitted That Met QC Criteria: November 12, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Post traumatic scars treatment

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No