Poly-L-Lactic Acid Threads Versus Platelet-Rich Plasma for Post-Traumatic Atrophic Scars (PLLA-PRP PTAS)
A Comparative Study of Poly-L-Lactic Acid Threads Versus Platelet-Rich Plasma, Both Combined With Subcision, in the Treatment of Post-Traumatic Atrophic Scars
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Post-traumatic atrophic scars result from abnormal healing following skin injury and may cause significant cosmetic and functional impairment. Subcision releases the fibrous bands tethering the scar to deeper tissues and may improve the response to additional treatments. PLLA threads are biodegradable materials that can stimulate collagen production, while PRP contains concentrated platelets and growth factors that may enhance tissue repair and remodeling.
This comparative study was conducted at the Dermatology and Venereology Department, Tanta University Hospital. Patients diagnosed with post-traumatic atrophic scars for at least one year and who had not received treatment during the preceding six months were enrolled. Patients with keloids, immunosuppression, coagulative or thrombophilic disorders, or chronic diseases were excluded.
Participants were divided into two equal treatment groups. Group A received a single session of subcision followed by insertion of poly-L-lactic acid threads. Group B received subcision combined with PRP injection for four sessions at one-month intervals. Clinical photographs were obtained before treatment and three months after treatment. Clinical improvement was assessed by two blinded dermatologists using the Global Aesthetic Improvement Scale, while patient satisfaction and treatment-related complaints or adverse effects were also recorded.
Skin biopsies were obtained from six patients before treatment and three months after treatment and evaluated using hematoxylin and eosin and trichrome staining to assess histopathological changes. All patients were followed for three months.
The study was approved by the Research Ethics Committee of the Faculty of Medicine, Tanta University, with approval number 32889/01/19, and informed consent was obtained from all participants.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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-
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Tanta, Ägypten
- Tanta University Hospitals
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Patients with post-traumatic atrophic scars. Scar duration of at least 1 year. No treatment received during the previous 6 months.
Exclusion Criteria:
- Keloids Immunosuppression Coagulative disorders Thrombophilic disorders Any chronic diseases
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: subcision and PLLA threads
subcision and PLLA threads' insertion at the same session
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subcision and PLLA threads' insertion at the same session
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Aktiver Komparator: PRP and subcision (PRP-S) injection
PRP and subcision (PRP-S) injection monthly for four sessions
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PRP and subcision (PRP-S) injection monthly for four sessions
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Global Aesthetic Improvement Scale (GAIS) score
Zeitfenster: 3 months after treatment
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Clinical improvement of post-traumatic atrophic scars was assessed using the Global Aesthetic Improvement Scale by two dermatologists blinded to the treatment group.
The scale was graded from 1 to 4: Grade 1 = mild/no improvement (0-25%), Grade 2 = moderate improvement (26-50%), Grade 3 = marked improvement (51-75%), and Grade 4 = excellent improvement (>75%).
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3 months after treatment
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 32889/01/19
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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