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Study to Determine if Fibrin Affects the Ability of a Wound to Heal

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01253135
First Posted: December 3, 2010
Last Update Posted: December 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Healthpoint
  Purpose
The objective of this study is to evaluate the potential inhibitory effects of HP802-247 Vehicle on wound closure (healing), by comparing mean days to closure of superficial (partial-thickness) thermal wounds against similar wounds treated with white petrolatum.

Condition Intervention Phase
Effect of Test Articles on the Healing of a Wound Artificially Induced by Liquid Nitrogen Spray Biological: Fibrin Other: White Petrolatum Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Evaluator-Blinded Study of the Effect of Polymerized Fibrin Applied Topically Once Per Week, on Healing of Induced Thermal Wounds, Versus Weekly Application of White Petrolatum

Resource links provided by NLM:


Further study details as provided by Healthpoint:

Primary Outcome Measures:
  • Time (in Days) to Wound Closure (Healing) Defined as Skin Re-epithelialization, Without Drainage or Dressing Requirements. [ Time Frame: All thermal wound injury was done on Day 1. Application of test articles started on Day 2. Target wound assessment was performed on Day 3 and Day 5; subsequent assessments were done Monday through Friday for 2 weeks and subjects exited study on Day 22 ]
    The target wounds were evaluated wound status (open/closed).

  • Median Time (in Days) to Wound Closure (Healing) Defined as Skin Re-epithelialization, Without Drainage or Dressing Requirements. [ Time Frame: All thermal wound injury was done on Day 1. Application of test articles started on Day 2. Target wound assessment was performed on Day 3 and Day 5; subsequent assessments were done Monday through Friday for 2 weeks and subjects exited study on Day 22 ]
    The target wounds were evaluated wound status (open/closed)


Enrollment: 40
Study Start Date: January 2011
Study Completion Date: November 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
White Petrolatum
Other: White Petrolatum
Topical application
Test article
Vehicle (fibrinogen)
Biological: Fibrin
Topical application of fibrinogen spray, followed by thrombin spray

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Provide written informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information.
  • Are male or female, ≥ 18 years of age, of any race.
  • Are willing to attend all required study visits, and to comply with study procedures.
  • Meet none of the exclusion criteria (any single exclusion criterion which is met by a potential subject will disqualify that subject from participation in this study.

Exclusion Criteria:

  • Have a history of dermatomyositis, systemic sclerosis, scleroderma, Sjögren's syndrome, systemic lupus erythematosus, discoid lupus, Ehler Danlos disease, icthyosis vulgaris, vasculitis, or bleeding disorders (coagulopathies).
  • Have any dermatologic disease which may be aggravated or provoked by the wounding procedure, such as Lichen Planus, Psoriasis, or Vitiligo.
  • Have Fitzpatrick scale skin type 6 (never sunburns, deeply pigmented).
  • Are at risk of keloid or hypertrophic scar formation, based on personal history, family history, or brief skin exam (conducted at the screening visit to look for keloids or hypertrophic scars).
  • Have been treated within the last three months for uncontrolled diabetes mellitus, peripheral vascular disease, vitamin C deficiency, connective tissue disorders, or any other disease process that impedes wound healing.
  • Are taking concomitant medications at doses which are known to interfere with healing, such as non-steroidal anti-inflammatory drugs, anti-neoplastic drugs, or immunosuppressive drugs.
  • Are using topical glycolic acid products, alpha-hydroxy acid products, retinoids, or chemical peel agents in the treatment areas.
  • Are using systemic steroids or immunosuppressant agents, or have used these drugs within the past three months.
  • The Principal Investigator may declare any subject ineligible for a valid medical reason.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01253135


Locations
United States, Florida
Dept of Dermatology, University of Miami
Miami., Florida, United States, 33136
Sponsors and Collaborators
Healthpoint
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Healthpoint
ClinicalTrials.gov Identifier: NCT01253135     History of Changes
Other Study ID Numbers: 802-247-09-017
First Submitted: November 30, 2010
First Posted: December 3, 2010
Results First Submitted: December 17, 2015
Results First Posted: December 21, 2015
Last Update Posted: December 21, 2015
Last Verified: December 2015

Keywords provided by Healthpoint:
Fibrin, white petrolatum, wound healing

Additional relevant MeSH terms:
Wounds and Injuries
Petrolatum
Emollients
Dermatologic Agents