Clinical trial NCT06681194: Silver Nitrate vs. Triamcinolone for Treatment of Hypergranulation Tissue
Official title: A Comparative Study of Silver Nitrate, Triamcinolone, and Their Successive Combined Use on Hypergranulation Tissue in Traumatic Wounds: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Wound Healing
Granulation Tissue
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial aims to compare the efficacy of silver nitrate, triamcinolone, and a successive use of both treatments in managing hypergranulation tissue in traumatic wounds. Conducted over a four-year period at UPMC Mercy, the study will involve patients presenting with hypergranulation tissue. Participants will be randomly assigned to receive either topical silver nitrate, topical triamcinolone, or a combination of the two in succession. The study will assess treatment outcomes based on the reduction or resolution of hypergranulation tissue, with the goal of identifying the most effective therapeutic approach. This research will provide valuable insights into optimizing treatment strategies for hypergranulation tissue in traumatic wounds.


Eligibility criteria: Inclusion Criteria:

* Patients must be 18 years or older.
* Patients must be admitted to the institution with non-infected, traumatic wounds exhibiting hypergranulation tissue.
* Patients must provide consent to participate in the study.
* Eligible wounds include superficial or partial-thickness wounds.
* Wounds will be categorized based on size and depth, with variations controlled for in the statistical analysis.

Exclusion Criteria:

* Patients with known allergies or contraindications to silver nitrate or triamcinolone.
* Patients with wounds that do not exhibit hypergranulation tissue.
* Patients with wounds not primarily due to traumatic injury (e.g., surgical wounds, pressure ulcers).
* Full-thickness, infected, or complex wounds will be excluded, as these may require different management strategies.

Primary outcomes:
measure: Reduction in Hypergranulation Tissue Size
timeFrame: From enrollment to 1 year after resolution of hypergranulation
measure: Vancouver Scar Scale (VSS)
timeFrame: From enrollment to 1 year after resolution of hypergranulation
measure: Time to healing
timeFrame: From enrollment to 1 year after resolution of hypergranulation
measure: Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: From enrollment to 1 year after resolution of hypergranulation
Secondary outcomes:
measure: Cutometry
timeFrame: From enrollment to 1 year after resolution of hypergranulation
measure: Scar color
timeFrame: From enrollment to 1 year after resolution of hypergranulation
measure: Treatment satisfaction
timeFrame: From enrollment to 1 year after resolution of hypergranulation
measure: Complications
timeFrame: From enrollment to 1 year after resolution of hypergranulation
measure: Numeric Rating Scale (NRS)
timeFrame: From enrollment to 1 year after resolution of hypergranulation
measure: Durometry
timeFrame: From enrollment to 1 year after resolution of hypergranulation
measure: Elastometry
timeFrame: From enrollment to 1 year after resolution of hypergranulation
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Mercy Hospital
state: Pennsylvania
Study officials:
affiliation: Department of Plastic Surgery, University of Pittsburgh Medical Center
name: Francesco M Egro, MD, MSc, MRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moio M, Mataro I, Accardo G, Canta L, Schonauer F. Treatment of hypergranulation tissue with intralesional injection of corticosteroids: preliminary results. J Plast Reconstr Aesthet Surg. 2014 Jun;67(6):e167-8. doi: 10.1016/j.bjps.2014.03.017. Epub 2014 Mar 26. No abstract available.
citation: Baumann ME, DeBruler DM, Blackstone BN, Coffey RA, Boyce ST, Supp DM, Bailey JK, Powell HM. Direct comparison of reproducibility and reliability in quantitative assessments of burn scar properties. Burns. 2021 Mar;47(2):466-478. doi: 10.1016/j.burns.2020.07.018. Epub 2020 Aug 2.
citation: McShane DB, Bellet JS. Treatment of hypergranulation tissue with high potency topical corticosteroids in children. Pediatr Dermatol. 2012 Sep-Oct;29(5):675-8. doi: 10.1111/j.1525-1470.2012.01724.x. Epub 2012 May 21.
citation: Linneman PK, Litt J. Hypertrophic Granulation Wounds Treated With Silver Nitrate Sticks or With Topical Steroid: Rate of Wound Closure. J Burn Care Res. 2022 Mar 23;43(2):403-407. doi: 10.1093/jbcr/irab196.
citation: Maynell KB, West W 3rd, Marek J, Wright B, Bodnar M, Le NK, Whalen K, Taylor L, Troy J, Smith D Jr, Laun J. Utilization of Topical Polysporin and Triamcinolone for the Treatment of Hypergranulation Tissue. J Burn Care Res. 2024 May 6;45(3):669-674. doi: 10.1093/jbcr/irad205.