Comparison of Recurrence Rate of Keloid After Excision Between Intra-operative Steroid Injection and Steroid With Platelet-rich Plasma Injection Combination Therapy

Keloid scars are benign skin lesions characterized by excessive collagen deposition, and their treatment remains challenging due to a high recurrence rate even after surgical excision. Combination therapies have been shown to be more effective than monotherapy. A common approach for treating recurrent keloids is surgical excision followed by intralesional corticosteroid injection; however, recurrence rates remain substantial. This study was conducted to evaluate the recurrence rate of keloid scars following surgical excision combined with intralesional corticosteroid and platelet-rich plasma (PRP) injection, compared to corticosteroid injection alone administered intraoperatively.

Study Overview

• Status: Active, not recruiting
• Conditions: Patients With Keloid Scar
• Intervention / Treatment: Drug: Intra-operative corticosteroid injection; Biological: Combined Intra-operative platelet-rich plasma with corticosteroid injection

• Study Type: Interventional
• Enrollment (Estimated): 212
• Phase: Phase 2

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10140
    • Department of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Aged 18 years or older
• Having keloid scars less than 10 centimeters in length
• Undergoing complete keloid excision (extralesional excision)
• Undergoing surgery under local anesthesia

Exclusion Criteria:

• Patients currently receiving immunosuppressive drugs or systemic steroids
• Patients with chronic diseases under active treatment, such as tuberculosis
• Pregnant or breastfeeding women
• Patients likely to have poor treatment adherence, such as those with cancer, epilepsy, or psychiatric disorders
• Patients with vascular diseases or hematologic/coagulation abnormalities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intra-operative corticosteroid injection; Intra-operative corticosteroid injection alone was administered around the surgical wound using triamcinolone acetonide (40 mg/ml). The injection was performed into the intradermal layer using a 30G needle, immediately after keloid excision and wound closure. The medication was injected along the wound edges following the suture line, at a dosage of 0.1 ml per 1 centimeter of wound length.	Drug: Intra-operative corticosteroid injection; Intra-operative corticosteroid injection alone was administered around the surgical wound using triamcinolone acetonide (40 mg/ml). The injection was performed into the intradermal layer using a 30G needle, immediately after keloid excision and wound closure. The medication was injected along the wound edges following the suture line, at a dosage of 0.1 ml per 1 centimeter of wound length.
Experimental: Combined Intra-operative platelet-rich plasma with corticosteroid injection; Combined Intra-operative platelet-rich plasma with corticosteroid injection was administered around the surgical wound. Each patient had 10 ml of blood collected into a RegenKit A-PRP tube. The blood-filled tube was then placed into a RegenLab PRP centrifuge and spun for approximately 5 minutes to obtain platelet-rich plasma (PRP), yielding around 5 ml of injectable PRP. Once prepared, the PRP was stored in the collection tube and used within 4 hours from the time of blood draw to the time of injection. After the keloid excision and wound closure were completed, the PRP was aseptically aspirated from the tube using a sterile needle and injected into the intradermal layer along the wound edges using a 30G needle. The injection was performed in a sterile manner, with a dosage of 0.5 ml of PRP per 1 centimeter of wound length. For corticosteroid administration, triamcinolone acetonide (40 mg/ml) was used. The medication was injected into the intradermal layer using a 30G needle along the	Biological: Combined Intra-operative platelet-rich plasma with corticosteroid injection; Combined Intra-operative platelet-rich plasma with corticosteroid injection was administered around the surgical wound. Each patient had 10 ml of blood collected into a RegenKit A-PRP tube. The blood-filled tube was then placed into a RegenLab PRP centrifuge and spun for approximately 5 minutes to obtain platelet-rich plasma (PRP), yielding around 5 ml of injectable PRP. Once prepared, the PRP was stored in the collection tube and used within 4 hours from the time of blood draw to the time of injection. After the keloid excision and wound closure were completed, the PRP was aseptically aspirated from the tube using a sterile needle and injected into the intradermal layer along the wound edges using a 30G needle. The injection was performed in a sterile manner, with a dosage of 0.5 ml of PRP per 1 centimeter of wound length. For corticosteroid administration, triamcinolone acetonide (40 mg/ml) was used. The medication was injected into the intradermal layer using a 30G needle along the

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence rate of keloid	Vancouver scar scale	Within 12 months after end of the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Itching at scar	Patient reported outcome using a questionnaire interview	Within 12 months after end of the intervention
Pain at scar	Patient reported outcome using a questionnaire interview	Within 12 months after end of the intervention
Skin atrophy	Clinical examination	Within 12 months after end of the intervention
Skin telangiectasia	Clinical examination	Within 12 months after end of the intervention

Collaborators and Investigators

• Sponsor: Ramathibodi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: May 1, 2025
• First Submitted That Met QC Criteria: May 1, 2025
• First Posted (Actual): May 11, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2025
• Last Update Submitted That Met QC Criteria: May 1, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Triamcinolone; Steroid; Keloid; Platelet rich plasma; PRP
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Connective Tissue Diseases; Cicatrix; Fibrosis; Collagen Diseases; Recurrence; Keloid
• Other Study ID Numbers: MURA2024/502

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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