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NCT Number: NCT06965088

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Bangkok, 10140, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. Recurrence rate of keloid

    Time frame: Within 12 months after end of the intervention

    Vancouver scar scale

Secondary outcomes

  1. Itching at scar

    Time frame: Within 12 months after end of the intervention

    Patient reported outcome using a questionnaire interview

  2. Pain at scar

    Time frame: Within 12 months after end of the intervention

    Patient reported outcome using a questionnaire interview

  3. Skin atrophy

    Time frame: Within 12 months after end of the intervention

    Clinical examination

  4. Skin telangiectasia

    Time frame: Within 12 months after end of the intervention

    Clinical examination

Sponsors and collaborators

Lead sponsor

Ramathibodi Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 11, 2025
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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