Skip to content

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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06965088
Enrollment
212
Registered
2025-05-11
Start date
2025-04-28
Completion date
2026-09-30
Last updated
2025-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients With Keloid Scar

Keywords

Keloid, Steroid, Triamcinolone, Platelet rich plasma, PRP

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.

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.

Sponsors

Ramathibodi Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Recurrence rate of keloidWithin 12 months after end of the interventionVancouver scar scale

Secondary

MeasureTime frameDescription
Itching at scarWithin 12 months after end of the interventionPatient reported outcome using a questionnaire interview
Pain at scarWithin 12 months after end of the interventionPatient reported outcome using a questionnaire interview
Skin atrophyWithin 12 months after end of the interventionClinical examination
Skin telangiectasiaWithin 12 months after end of the interventionClinical examination

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026