Wound HealingPhase 2/3NCT06681194
Silver Nitrate vs. Triamcinolone for Treatment of Hypergranulation Tissue
A Phase 2/3 study testing Silver Nitrate, triamcinolone and Silver nitrate + triamcinolone in people with Wound Healing and Granulation Tissue, run by Francesco Egro at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Healing, Granulation Tissue
- What is being tested?
- Silver Nitrate, triamcinolone and Silver nitrate + triamcinolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to 3 Feb 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of Silver Nitrate, Triamcinolone, and Their Successive Combined Use on Hypergranulation Tissue in Traumatic Wounds: A Randomized Control Trial
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.
- Conditions
- Wound Healing, Granulation Tissue
- Being tested
- Silver Nitrate, triamcinolone, Silver nitrate + triamcinolone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver NitrateDrug
See "Silver nitrate only" study arm
triamcinoloneDrug
See "Triamcinolone only" study arm
Silver nitrate + triamcinoloneDrug
See "Combination group" study arm
| Study group | Role | What they receive |
|---|---|---|
| Triamcinolone only | Active comparator | Patients in the triamcinolone group receive triamcinolone 0.5% applied topically to the hypergranulation tissue during their inpatient stay. Upon discharge, patients continue with the same triamcinolone 0.5% treatment, applying it once daily to affected areas in the outpatient setting. Treatment continues until either resolution of hypergranulation tissue (typically within 3-4 weeks) or until 8 weeks have passed without resolution, at which point the patient is considered a treatment failure if open areas persist. Standard wound care practices including appropriate dressings and antibiotics are maintained throughout the treatment period. Receives: Drug: triamcinolone |
| Silver nitrate only | Active comparator | During the inpatient phase, patients in this group receive treatment with silver nitrate sticks applied directly to the hypergranulation tissue. Upon discharge, patients transition to using 0.5% silver nitrate solution for outpatient care, which is applied once daily to the affected areas. The switch to solution form for outpatient treatment is made because it is less painful and easier to apply, particularly on difficult-to-access areas of the body. Treatment continues until either resolution of hypergranulation tissue (typically occurring within 3-4 weeks) or until 8 weeks have passed without resolution, at which point the patient is considered a treatment failure if open areas persist. Throughout the treatment period, standard wound care practices including appropriate dressings and antibiotics are maintained. Receives: Drug: Silver Nitrate |
| Combination group | Experimental | The combination group receives treatment with silver nitrate sticks applied directly to the hypergranulation tissue during their inpatient stay. Upon discharge, patients switch from silver nitrate to triamcinolone 0.5%, which they apply once daily to affected areas in the outpatient setting. This treatment continues until either resolution of hypergranulation tissue (typically within 3-4 weeks) or until 8 weeks have passed without resolution, at which point the patient is considered a treatment failure if open areas persist. Standard wound care practices including appropriate dressings and antibiotics are maintained throughout. This combination approach aims to leverage both the initial cauterizing and antimicrobial effects of silver nitrate with the subsequent anti-inflammatory benefits of triamcinolone. Receives: Drug: Silver nitrate + triamcinolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Hypergranulation Tissue Size
The investigators will report the changes in hypergranulation tissue size, assessing the change from baseline to follow-up. This will include measuring the hypergranulation size and tracking the percentage reduction over time for participants, with photographic documentation taken at baseline, resolution, and up to one year post-resolution to visually compare size changes. The outcome will evaluate the efficacy of each treatment through clinical observation and standardized wound assessment tools, ensuring that volume is documented as a distinct entry to comply with reporting requirements.
Measured: From enrollment to 1 year after resolution of hypergranulation
Vancouver Scar Scale (VSS)
The scale measures scar characteristics based on color, pliability, height, and area. The VSS consists of three components: 1) Color (0-3), 2) Pliability (0-3), and 3) Height (0-3), with a total area score calculated based on the size of the scar. The overall score ranges from 0 to 13, where 0 indicates normal skin and higher scores represent worse scar quality. Specifically, higher values in color, pliability, and height indicate more severe scarring, while the area score provides an additional measure of size. The individual scores for color, pliability, and height can be summed to compute the total score, with the area score added to provide a comprehensive assessment of scar severity.
Measured: From enrollment to 1 year after resolution of hypergranulation
Time to healing
This outcome records the duration required for the wound to reach significant improvement or closure, helping to assess the treatment's efficiency.
Measured: From enrollment to 1 year after resolution of hypergranulation
Patient and Observer Scar Assessment Scale (POSAS)
The scale measures the quality of scars from both patient and observer perspectives. The scale includes two main components: the Patient Scale and the Observer Scale. Each component consists of 6 items rated on a scale from 1 to 10, where 1 represents "no scar" and 10 represents "the worst scar imaginable," allowing for a total score range of 6 to 60 for each scale. Higher scores indicate worse outcomes, reflecting greater scar severity and patient distress. To compute a total score, the subscale scores can be summed, providing an overall assessment of scar quality from both perspectives.
Measured: From enrollment to 1 year after resolution of hypergranulation
Secondary outcomes (7)
Cutometry
This outcome assesses the structural integrity of the skin post-treatment, measured using a cutometer. The cutometer evaluates skin firmness and elasticity by applying a vacuum to the skin and measuring the degree of deformation. This assessment provides quantitative data on how well the skin maintains its structure after hypergranulation treatment, allowing for a comparison of improvements over time.
Measured: From enrollment to 1 year after resolution of hypergranulation
Scar color
Using colorimetry, this outcome measures changes in skin/scar color, providing insights into the effects of the treatments on skin appearance.
Measured: From enrollment to 1 year after resolution of hypergranulation
Treatment satisfaction
The satisfaction scale for evaluating hypergranulation treatment uses a numeric scale from 1 to 10, where respondents indicate their level of satisfaction with the treatment. A score of 1 represents "Very Dissatisfied," indicating complete unhappiness with the treatment, while a score of 10 signifies "Completely Satisfied," reflecting total contentment with the treatment and its outcomes. This scale allows patients to provide a clear, quantifiable assessment of their treatment experience, which can inform improvements in care and patient outcomes.
Measured: From enrollment to 1 year after resolution of hypergranulation
Complications
This outcome will report the number of participants experiencing any complications related to hypergranulation treatment, including infection, skin sloughing, and delayed wound healing. By tracking these complications, the investigators will evaluate the safety profile of each treatment method. Specifically, the investigators will document the incidence of each complication, providing a clear metric for assessing the overall safety and tolerability of the treatments used. This information will be crucial for understanding the risks associated with each approach and guiding future treatment decisions.
Measured: From enrollment to 1 year after resolution of hypergranulation
Numeric Rating Scale (NRS)
The Numeric Rating Scale (NRS) for pain is a subjective measure used to assess a patient's level of pain on a scale from 0 to 10. Patients are asked to rate their pain by selecting a number that best represents their current pain level. This scale allows healthcare providers to quickly gauge the severity of pain and monitor changes over time, facilitating appropriate pain management strategies.
Measured: From enrollment to 1 year after resolution of hypergranulation
Durometry
The mechanical properties of the skin will be evaluated using a durometer, which measures the hardness of the skin. This measurement reflects the skin's resilience and texture following treatment. By documenting changes in skin hardness, the investigators can gain insights into how the treatment affects the skin's overall quality and tactile properties, contributing to a comprehensive understanding of treatment efficacy.
Measured: From enrollment to 1 year after resolution of hypergranulation
Elastometry
Skin elasticity will be assessed using an elastometer, which quantifies the skin's ability to stretch and return to its original shape. This outcome reflects improvements in the skin's mechanical properties and overall health post-treatment. By analyzing the elasticity of the skin, the investigators can better understand the treatment's impact on skin recovery and resilience, providing valuable information for patient care and outcomes.
Measured: From enrollment to 1 year after resolution of hypergranulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start1 Mar 2025
- Primary completion2 Feb 2026
- Study completion3 Feb 2026
Why it stopped: No subjects recruited at this time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Francesco Egro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francesco Egro, University of Pittsburgh
- Investigators
- Francesco M Egro, MD, MSc, MRCS, Principal investigator, Department of Plastic Surgery, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681194
- Sponsor's protocol ID
- STUDY24070165
- Status last verified
- Jul 2026
- First submitted
- 6 Nov 2024
- Last updated
- 22 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators may provide deidentified patient information journals if requested; however, the investigators are currently undecided about the likelihood of such requests. While the investigators recognize the importance of data sharing for advancing research, the investigators must consider patient confidentiality and ethical considerations when determining the approach.
Publications
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.
PubMed 24725728Baumann 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.
PubMed 32839037McShane 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.
PubMed 22612258Linneman 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.
PubMed 34687202Maynell 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.
PubMed 38165005
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Silver Nitrate, Triamcinolone, and Their Successive Combined Use on Hypergranulation Tissue in Traumatic Wounds: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06681194
- Acronym / sponsor ID
- STUDY24070165
- Conditions
- Wound Healing, Granulation Tissue
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No subjects recruited at this time
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Francesco EgroUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 2 Feb 2026 (actual)
- Study completion
- 3 Feb 2026 (actual)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Triamcinolone only | Active comparator | Drug: triamcinolonePatients in the triamcinolone group receive triamcinolone 0.5% applied topically to the hypergranulation tissue during their inpatient stay. Upon discharge, patients continue with the same triamcinolone 0.5% treatment, applying it once daily to affected areas in the outpatient setting. Treatment continues until either resolution of hypergranulation tissue (typically within 3-4 weeks) or until 8 weeks have passed without resolution, at which point the patient is considered a treatment failure if open areas persist. Standard wound care practices including appropriate dressings and antibiotics are maintained throughout the treatment period. |
| Silver nitrate only | Active comparator | Drug: Silver NitrateDuring the inpatient phase, patients in this group receive treatment with silver nitrate sticks applied directly to the hypergranulation tissue. Upon discharge, patients transition to using 0.5% silver nitrate solution for outpatient care, which is applied once daily to the affected areas. The switch to solution form for outpatient treatment is made because it is less painful and easier to apply, particularly on difficult-to-access areas of the body. Treatment continues until either resolution of hypergranulation tissue (typically occurring within 3-4 weeks) or until 8 weeks have passed without resolution, at which point the patient is considered a treatment failure if open areas persist. Throughout the treatment period, standard wound care practices including appropriate dressings and antibiotics are maintained. |
| Combination group | Experimental | Drug: Silver nitrate + triamcinoloneThe combination group receives treatment with silver nitrate sticks applied directly to the hypergranulation tissue during their inpatient stay. Upon discharge, patients switch from silver nitrate to triamcinolone 0.5%, which they apply once daily to affected areas in the outpatient setting. This treatment continues until either resolution of hypergranulation tissue (typically within 3-4 weeks) or until 8 weeks have passed without resolution, at which point the patient is considered a treatment failure if open areas persist. Standard wound care practices including appropriate dressings and antibiotics are maintained throughout. This combination approach aims to leverage both the initial cauterizing and antimicrobial effects of silver nitrate with the subsequent anti-inflammatory benefits of triamcinolone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silver NitrateSee "Silver nitrate only" study arm | Drug | Silver nitrate only |
| triamcinoloneSee "Triamcinolone only" study arm | Drug | Triamcinolone only |
| Silver nitrate + triamcinoloneSee "Combination group" study arm | Drug | Combination group |
Primary outcome
Reduction in Hypergranulation Tissue Size
Time frame: From enrollment to 1 year after resolution of hypergranulation
The investigators will report the changes in hypergranulation tissue size, assessing the change from baseline to follow-up. This will include measuring the hypergranulation size and tracking the percentage reduction over time for participants, with photographic documentation taken at baseline, resolution, and up to one year post-resolution to visually compare size changes. The outcome will evaluate the efficacy of each treatment through clinical observation and standardized wound assessment tools, ensuring that volume is documented as a distinct entry to comply with reporting requirements.
Vancouver Scar Scale (VSS)
Time frame: From enrollment to 1 year after resolution of hypergranulation
The scale measures scar characteristics based on color, pliability, height, and area. The VSS consists of three components: 1) Color (0-3), 2) Pliability (0-3), and 3) Height (0-3), with a total area score calculated based on the size of the scar. The overall score ranges from 0 to 13, where 0 indicates normal skin and higher scores represent worse scar quality. Specifically, higher values in color, pliability, and height indicate more severe scarring, while the area score provides an additional measure of size. The individual scores for color, pliability, and height can be summed to compute the total score, with the area score added to provide a comprehensive assessment of scar severity.
Time to healing
Time frame: From enrollment to 1 year after resolution of hypergranulation
This outcome records the duration required for the wound to reach significant improvement or closure, helping to assess the treatment's efficiency.
Patient and Observer Scar Assessment Scale (POSAS)
Time frame: From enrollment to 1 year after resolution of hypergranulation
The scale measures the quality of scars from both patient and observer perspectives. The scale includes two main components: the Patient Scale and the Observer Scale. Each component consists of 6 items rated on a scale from 1 to 10, where 1 represents "no scar" and 10 represents "the worst scar imaginable," allowing for a total score range of 6 to 60 for each scale. Higher scores indicate worse outcomes, reflecting greater scar severity and patient distress. To compute a total score, the subscale scores can be summed, providing an overall assessment of scar quality from both perspectives.
7 secondary outcomes
Cutometry
Time frame: From enrollment to 1 year after resolution of hypergranulation
Scar color
Time frame: From enrollment to 1 year after resolution of hypergranulation
Treatment satisfaction
Time frame: From enrollment to 1 year after resolution of hypergranulation
Complications
Time frame: From enrollment to 1 year after resolution of hypergranulation
Numeric Rating Scale (NRS)
Time frame: From enrollment to 1 year after resolution of hypergranulation
Durometry
Time frame: From enrollment to 1 year after resolution of hypergranulation
Elastometry
Time frame: From enrollment to 1 year after resolution of hypergranulation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Background: PubMed 24725728Moio 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.
- Background: PubMed 32839037Baumann 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.
- Background: PubMed 22612258McShane 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.
- Background: PubMed 34687202Linneman 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.
- Background: PubMed 38165005Maynell 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.
- Individual participant dataSharing planned: Undecided. The investigators may provide deidentified patient information journals if requested; however, the investigators are currently undecided about the likelihood of such requests. While the investigators recognize the importance of data sharing for advancing research, the investigators must consider patient confidentiality and ethical considerations when determining the approach.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco M Egro, MD, MSc, MRCS principal investigator
Department of Plastic Surgery, University of Pittsburgh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Silver Nitrate, triamcinolone and Silver nitrate + triamcinolone in people with Wound Healing and Granulation Tissue, run by Francesco Egro at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Hypergranulation Tissue Size (time frame: From enrollment to 1 year after resolution of hypergranulation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06681194, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.