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

Phase 2

Active, not recruiting

• Conditions: Patients With Keloid Scar
• Interventions: Drug: Intra-operative corticosteroid injection; Biological: Combined Intra-operative platelet-rich plasma with corticosteroid injection

• Registration Number: NCT06965088
• Lead Sponsor: Ramathibodi Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-28
• Status Verified: 2025-05
• Study First Submitted: 2025-05-01
• Study First Submitted QC: 2025-05-01
• Last Update Submitted: 2025-05-01
• Study First Posted: 2025-05-11
• Last Update Posted: 2025-05-11
• Primary Completion: 2026-06-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 212

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intra-operative corticosteroid injection	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.
Combined Intra-operative platelet-rich plasma with corticosteroid injection	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

Primary Outcome Measures

Name	Time	Method
Recurrence rate of keloid	Within 12 months after end of the intervention	Vancouver scar scale

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand