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Clinical Trials/NCT06135480
NCT06135480CompletedNot Applicable

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

Assiut University2 sites in 1 country36 target enrollmentStarted: November 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
36
Locations
2
Primary Endpoint
Scar severity grading

Study Overview

Brief Summary

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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
12 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Scar severity grading

Time Frame: after 1 month of treatment completion.

Scar severity grading will be evaluated by blinded dermatologist

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Howida Omar Twisy

principal investigator

Assiut University

Study Sites (2)

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