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

NCT06965088 | Active Not Recruiting Phase 2

• 1 other identifier: MURA2024/502
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Patients With Keloid Scar

Keywords

Keloid; Steroid; Triamcinolone; Platelet rich plasma; PRP

Outcome Measures

Primary Outcomes (1)

• Recurrence rate of keloid

  Vancouver scar scale

  Within 12 months after end of the intervention

Secondary Outcomes (4)

• Itching at scar

  Within 12 months after end of the intervention

• Pain at scar

  Within 12 months after end of the intervention

• Skin atrophy

  Within 12 months after end of the intervention

• Skin telangiectasia

  Within 12 months after end of the intervention

Study Arms (2)

Intra-operative corticosteroid injection

ACTIVE COMPARATOR

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

Combined Intra-operative platelet-rich plasma with corticosteroid injection

EXPERIMENTAL

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

Interventions

Combined Intra-operative platelet-rich plasma with corticosteroid injection BIOLOGICAL

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

Combined Intra-operative platelet-rich plasma with corticosteroid injection

Intra-operative corticosteroid injection DRUG

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.

Intra-operative corticosteroid injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ramathibodi Hospital: lead

Study Sites (1)

Department of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University

Bangkok, Bangkok, 10140, Thailand

Location

MeSH Terms

Conditions

Keloid

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chanokchon Kongkergkiat, M.D.

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 11, 2025
• Study Start: April 28, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 11, 2025

Record last verified: 2025-05

Locations

TH (1)