Wounds and Injuries Clinical Trial
Official title:
The Molecular Anatomy of Oral Wound Healing
Verified date | February 19, 2019 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background:
- Two important properties distinguish the healing process of skin wounds from that of
wounds of the mucous membranes of the mouth (oral mucosa). Although the skin and the
oral mucosa tissues are similar in nature, oral mucosa have more rapid healing and a
lack of scar tissue formation. However, oral wound healing in general has been poorly
studied, and more information is needed to determine how specific aspects of the oral
environment affect the healing process.
- Researchers are interested in identifying various factors that contribute to oral wound
healing. Studying this process would help researchers explore procedures to accelerate
the healing of critically-sized oral lesions formed by trauma, surgery, radiation
therapy, infection, and other damage to the mouth. In addition, research into scar-free
healing could be applied to other mucosal sites to promote healing and minimize
unsightly scars that may compromise the tissue.
Objectives:
- To identify the specific factors that enable rapid and nearly scar-free healing of oral
mucosa.
Eligibility:
- Healthy male volunteers between 18 and 40 years of age.
- Regular cigarette, cigar, and pipe smokers; occasional smokers who smoke more than 1 day
a week or have smoked in the prior month; users of chewing tobacco or betel nut; and
heavy drinkers (three or more alcoholic drinks per day) will be excluded.
Design:
- Participants will have a medical history and examination, and will provide blood samples
at the start of the study.
- Participants will provide oral mucosa samples from the inside of the cheek, taken using
a dermal punch. At the same time, participants will provide skin biopsy samples of
approximately the same size. After the skin and oral mucosa samples are taken,
participants will be divided into three groups for follow-up procedures.
- Group 1: No further samples will be collected. This group will help document the normal
healing process.
- Group 2: A second, slightly larger biopsy, which will include the area of the first
biopsy, will be taken on day 3. Both skin and oral mucosa biopsies will be taken.
- Group 3: A second, slightly larger biopsy will be taken on day 6, in a similar way as
described for Group 2. Both skin and oral mucosa biopsies will be taken.
- Wounds will be photographed with a digital camera on days 3, 6, 9, 13, and 15; and the
healing will be monitored at the scheduled clinic visits.
Status | Completed |
Enrollment | 53 |
Est. completion date | February 19, 2019 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 40 Years |
Eligibility |
- INCLUSION CRITERIA: - Healthy male volunteers age 18 to 40. - All volunteers must sign informed consent indicating their understanding that specimens and demographic information will be collected solely for research purposes. EXCLUSION CRITERIA: Subjects with known inflammatory, chronic, and infectious diseases. These conditions include but are not limited to: - Diabetes - Heart failure - Pulmonary disease - Rheumatoid arthritis - Systemic lupus erythematosus - Sarcoidosis - Sj(SqrRoot)(Delta)grens syndrome - Dermatomyositis - Psoriasis - Cellulitis Patients with known bleeding disorders or conditions associated with bleeding. These conditions include but are not limited to: - Hemophilia - von Willebrand disease - Protein C/S deficiency - Antithrombin III deficiency - Liver disease - Patients on medications that interfere with blood clotting or blood thinners. These medications include but are not limited to: ibuprofen aspirin, warfarin (Coumadin), ticlopidine (Ticlid), clopidogrel (Plavix), and others. - Subjects with clinically significant abnormal laboratory values will be ineligible Complete blood count (CBC) Platelet level: <100 - >500/ 10(3)/mcL<TAB> Hemoglobin: <10; > 17.5gr/L<TAB> Hematocrit: <30; >51%<TAB> White blood cell count: <3; >12 10(3)/mcL Partial thromboplastin time: <20; >42 sec Prothrombin time: <10; >20 sec C-reactive protein: > 4 mg/L Erythrocyte sedimentation rate: >40 ml/h - Recent unintentional weight loss of >10 lbs over the past 6 weeks prior to screening - Have undergone general or oral surgery within the last 30 days - Treated with systemic steroids in the past 12 months - Subjects with a history of abnormal scar formation (i.e., keloids, hypertrophic scarring) - Subjects who have used tobacco products and/or betel nut within one month of the screening evaluation. Tobacco products include cigarette, pipe, cigar, and chewing tobacco - Heavy drinkers defined as drinking greater than or equal to alcoholic drinks per day - Subjects that, at the oral clinical examination, show any of the nonmalignant lesions associated with heavy smoking/tobacco chewing will be excluded. These findings include but are not limited to: - Tooth stains - abrasions - smoker s melanosis - acute necrotizing gingivitis - burns - erythematous or keratotic patches - black hairy tongue - nicotinic stomatitis - palatal erosions - Subjects with preneoplastic (leukoplakia, erythroplakia, submucous fibrosis) or neoplastic lesions - Subjects with known or suspected allergies or adverse reactions to any of the agents used for skin preparation, local anesthesia, or pain control or with known or suspected allergy or adverse reaction to Prolene (polypropylene) sutures |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Dental and Craniofacial Research (NIDCR) |
United States,
Baker H, Patel V, Molinolo AA, Shillitoe EJ, Ensley JF, Yoo GH, Meneses-García A, Myers JN, El-Naggar AK, Gutkind JS, Hancock WS. Proteome-wide analysis of head and neck squamous cell carcinomas using laser-capture microdissection and tandem mass spectrometry. Oral Oncol. 2005 Feb;41(2):183-99. — View Citation
Lee HG, Eun HC. Differences between fibroblasts cultured from oral mucosa and normal skin: implication to wound healing. J Dermatol Sci. 1999 Nov;21(3):176-82. — View Citation
Schäfer M, Werner S. Transcriptional control of wound repair. Annu Rev Cell Dev Biol. 2007;23:69-92. Review. — View Citation
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04554212 -
Blood Flow Restriction Training After Patellar INStability
|
N/A | |
Suspended |
NCT02932176 -
Machine Learning for Handheld Vascular Studies
|
||
Recruiting |
NCT04803253 -
Study of the Social and Professional Reintegration Improvements Using a Set of Solutions for Upper Limb Amputation
|
N/A | |
Completed |
NCT00116337 -
Spinal Cord Stimulation to Restore Cough
|
N/A | |
Completed |
NCT03463720 -
Outcome for Patients With War-Associated Extremity Wound Infection
|
N/A | |
Completed |
NCT03113253 -
TRANexamic Acid to Reduce Bleeding in BURN Surgery
|
Phase 4 | |
Not yet recruiting |
NCT05492903 -
COMmunity of Practice And Safety Support for Navigating Pain (COMPASS-NP)
|
N/A | |
Terminated |
NCT02909231 -
One-year Patient Reported Outcomes Following Hospitalization for Trauma
|
N/A | |
Completed |
NCT02432456 -
Ketamine Infusion Therapy for the Management of Acute Pain in Adult Rib Fracture Patients
|
Phase 4 | |
Completed |
NCT02744144 -
Wound Bacterial Microbiota and Their Antibiotic Resistance
|
N/A | |
Completed |
NCT02266771 -
Impact of V.A.C. Veraflo Therapy in Wounds Requiring Debridement Within an Orthopedic Practice
|
N/A | |
Completed |
NCT02394821 -
Odor Management in Fungating Wounds Comparing Metronidazole and Polihexanide
|
Phase 3 | |
Not yet recruiting |
NCT01665963 -
Efficacy of TopClosure(C)System in Healing Complicated Pacemaker Wounds
|
N/A | |
Completed |
NCT00151112 -
Comparison of Two Different Procedures for Plexus Anesthesia
|
N/A | |
Not yet recruiting |
NCT03872544 -
Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
|
||
Recruiting |
NCT04596124 -
Effectiveness and Tolerability of Fitostimoline Plus Cream and Gauze vs Connettivina Bio Plus Cream and Gauze
|
N/A | |
Recruiting |
NCT05800834 -
Benefits of Morphine Gel for Pain Reduction in Patients With Cancer Wounds
|
Phase 2 | |
Enrolling by invitation |
NCT03880188 -
Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
|
||
Terminated |
NCT04775316 -
Prospective, International, Multicenter, Observational Study to Evaluate the Clinical Performance and Safety of a Silicone-coated Transparent Postoperative Dressing
|
||
Enrolling by invitation |
NCT03312504 -
Implementing a School Prevention Program to Reduce Injuries Through Neuromuscular Training
|
N/A |