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

Mahidol University

Status and phase: Active, not recruiting; Phase 2

Conditions: Patients With Keloid Scar

Treatments: Biological: Combined Intra-operative platelet-rich plasma with corticosteroid injection; Drug: Intra-operative corticosteroid injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06965088

MURA2024/502

Details and patient eligibility

About

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.

Enrollment: 212 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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212 participants in 2 patient groups

Intra-operative corticosteroid injection

Active Comparator group

Description:

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.

Treatment:

Drug: Intra-operative corticosteroid injection

Combined Intra-operative platelet-rich plasma with corticosteroid injection

Experimental group

Description:

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

Treatment:

Biological: Combined Intra-operative platelet-rich plasma with corticosteroid injection