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The goal of this clinical trial is to determine whether the application of brief topical cryotherapy immediately before intralesional corticosteroid injections can reduce pain and injection resistance during routine treatment of keloid and hypertrophic scars in adult patients.
The main questions it aims to answer are:
Does topical cryotherapy applied before intralesional triamcinolone injection impact pain perceptions for participants with keloids or hypertrophic scars?
Does topical cryotherapy affect provider-assessed injection resistance compared with standard injection alone?
Researchers will split the keloid/hypertrophic scar into two halves. One half will be treated with cryotherapy followed by steroid injection, while the other half will be treated with steroid injection alone to evaluate differences in pain perception and injection resistance.
Participants will rate pain after each injection using a 10-point numeric pain scale. Clinicians will rate the resistance after each injection using a 10-point numeric scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryotherapy + Steroids vs Steroids alone | Experimental | A provider will divide the identified keloid into two halves. The division will be marked down the center using a sterile skin marker under standard aseptic conditions. The provider will then administer the intervention; one half of the keloid will receive cryoanesthesia with liquid nitrogen spray (~10 seconds). Within the next 60 seconds, standard intralesional triamcinolone (10-40 mg/mL) will be injected in that half using an identical needle gauge, depth, and volume planned for clinical care. The other half will receive standard intralesional triamcinolone only with an identical injection technique and dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryotherapy with liquid nitrogen | Device | liquid nitrogen spray (~10 seconds) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient pain perceptions | Pain perception during intralesional corticosteroid injection will be assessed using a patient-reported numeric rating scale (0 = No pain, 10 = Very severe pain). | Immediately following intralesional corticosteroid injection (same visit) |
| Provider-reported resistance of injection | Dermatology providers will rate resistance of the intralesional corticosteroid injection using a 10-point numeric scale (0 = No resistance to 10 = Very strong resistance). | Immediately following intralesional corticosteroid injection (same visit) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sonal Choudhary, MD | Contact | 7867182737 | choudharys@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sonal Choudhary | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15213-3427 | United States |
De-identified individual participant data will not be shared to protect participants' privacy; only aggregate results will be reported.
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| ID | Term |
|---|---|
| D007627 | Keloid |
| D017439 | Cicatrix, Hypertrophic |
| ID | Term |
|---|---|
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002921 | Cicatrix |
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| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Intralesional Triamcinolone 10 mg/ml | Drug | Intralesional triamcinolone |
|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |