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Skin Barrier Function

Wound Healing Interventions for Chronic Wounds

Phase 4
Waitlist Available
Led By Gayle M Gordillo, M.D.
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial studies wound healing in 265 patients with infected burns or chronic wounds; 89% will heal in 16 weeks, and 234 continue for further study.

Eligible Conditions
  • Burns
  • Chronic Wounds
  • Foot Ulcer
  • Pressure Sores
  • Venous Leg Ulcer
  • Chronic
  • Wound

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Biofilm Infection effects to TEWL at wound sites
Ceramiseal and EpiCeram restore barrier function to wounds in patients

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: High TEWL - Epiceram skin barrier functionExperimental Treatment1 Intervention
Subjects will have the TEWL reading completed at the wound site and a control site (anatomically matched site on the patients contralateral side) at the second study visit. If the wound site reading is less than 3 times the value of the control site subjects
Group II: High TEWL - CeramisealExperimental Treatment1 Intervention
Subjects will have the TEWL reading completed at the wound site and a control site (anatomically matched site on the patients contralateral side) at the second study visit. If the wound site reading is less than 3 times the value of the control site
Group III: Low TEWLActive Control1 Intervention
Subjects will have the TEWL reading completed at the wound site and a control site (anatomically matched site on the patients contralateral side) at the second study visit. If the wound site reading is less than 3 times the value of the control site subjects will be be discontinued from the study.
Group IV: High TEWL - No treatmentActive Control1 Intervention
Subjects will have the TEWL reading completed at the wound site and a control site (anatomically matched site on the patients contralateral side) at the second study visit. If the wound site reading is less than 3 times the value of the control site subjects
Group V: High TEWL - Vaseline Petroleum JellyPlacebo Group1 Intervention
Subjects will have the TEWL reading completed at the wound site and a control site (anatomically matched site on the patients contralateral side) at the second study visit. If the wound site reading is less than 3 times the value of the control site subjects

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
980 Previous Clinical Trials
981,497 Total Patients Enrolled
2 Trials studying Burns
68 Patients Enrolled for Burns
National Institute of Nursing Research (NINR)NIH
580 Previous Clinical Trials
10,376,296 Total Patients Enrolled
Gayle M Gordillo, M.D.Principal InvestigatorIndiana University
1 Previous Clinical Trials
45 Total Patients Enrolled

Media Library

Ceramiseal (Skin Barrier Function) Clinical Trial Eligibility Overview. Trial Name: NCT02577120 — Phase 4
Burns Research Study Groups: High TEWL - Epiceram skin barrier function, High TEWL - Ceramiseal, High TEWL - Vaseline Petroleum Jelly, Low TEWL, High TEWL - No treatment
Burns Clinical Trial 2023: Ceramiseal Highlights & Side Effects. Trial Name: NCT02577120 — Phase 4
Ceramiseal (Skin Barrier Function) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02577120 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment have any vacancies for participants?

"Clinicaltrials.gov reports that this clinical trial is presently looking for subjects, having initially been posted on the 9th of January 2019 and most recently updated on the 11th of May 2023."

Answered by AI

Has the FDA granted authorization for High TEWL - Epiceram to be used as a skin barrier?

"There is ample clinical data affirming the safety of High TEWL - Epiceram skin barrier function, earning it a score of 3. As this treatment has been approved and released to the market, Phase 4 trials are being conducted."

Answered by AI

For what conditions is High TEWL - Epiceram skin barrier function employed therapeutically?

"Epiceram is often prescribed for the relief of dry eye syndrome and other related condtions such as pruritus ani, irritated skin, and throat infection. This drug works to improve TEWL (transepidermal water loss) which helps restore a healthy epidermis."

Answered by AI

Have other studies been conducted to analyze the efficacy of High TEWL - Epiceram as a skin barrier?

"Currently, there are 10 active investigations into High TEWL - Epiceram skin barrier function with none in Phase 3. Of these trials, the majority of them are underway at locations around Boston, Massachusetts; however, 16 other places across the United States also have studies running for this purpose."

Answered by AI

Could you provide an approximate figure for the number of participants in this clinical experiment?

"Affirmative. The clinicaltrials.gov database advertises that this medical trial is actively recruiting participants, having been initially posted on September 1st 2019 and last revised on May 11th 2023. A total of 265 patients need to be enlisted from a single research centre."

Answered by AI
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~33 spots leftby Feb 2025