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Active, not recruitingNCT06965088Updated May 11, 2025

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

A Phase 2 interventional study of Combined Intra-operative platelet-rich plasma with corticosteroid injection and Intra-operative corticosteroid injection in Patients With Keloid Scar, sponsored by Ramathibodi Hospital. Active, not recruiting at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-11.

Sponsored by Ramathibodi Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
212
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Patients With Keloid Scar

Keywords

  • Keloid
  • Steroid
  • Triamcinolone
  • Platelet rich plasma
  • PRP
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
212 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • BiologicalCombined 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

  • DrugIntra-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.

05

What researchers measure

Primary outcomes

  1. Recurrence rate of keloid

    Vancouver scar scale

    Time frame: Within 12 months after end of the intervention

Secondary outcomes

  1. Itching at scar

    Patient reported outcome using a questionnaire interview

    Time frame: Within 12 months after end of the intervention

  2. Pain at scar

    Patient reported outcome using a questionnaire interview

    Time frame: Within 12 months after end of the intervention

  3. Skin atrophy

    Clinical examination

    Time frame: Within 12 months after end of the intervention

  4. Skin telangiectasia

    Clinical examination

    Time frame: Within 12 months after end of the intervention

06

Study locations

1 site
  • Department of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University
    Bangkok, 10140, Thailand
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06965088
Lead sponsor
Ramathibodi Hospital
Responsible party
Chanokchon Kongkergkiat (Chanokchon Kongkergkiat, M.D., Ramathibodi Hospital) — Principal investigator
First posted
May 11, 2025
Start date
Apr 28, 2025
Primary completion
Jun 30, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
May 11, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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