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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Tanta, Egypte
- Tanta University Hospitals
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Global Aesthetic Improvement Scale (GAIS) score
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 32889/01/19
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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