AzTrials
AzTrials

Skin UlcerPhase 4NCT02813213

Effectiveness Comparison of Skin Micro-grafts vs Meshed Split Thickness Skin Grafts

A Phase 4 study testing Skin micro Grafts and Standard skin graft in people with Skin Ulcer and Burns, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This is a double-blind randomized controlled clinical trial, that compares the percentage of epithelialization of skin defects using the conventional meshed split thickness skin grafts vs skin micro grafts. Two techniques will be applied in the same patient. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Skin Ulcer, Burns
What is being tested?
Skin micro Grafts and Standard skin graft
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteMexico
Study dates
Jun 2016to Sep 2018
Phase
Phase 4
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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Non complicated wounds (no infection, no cancer)
  • Wound area: 20 x 20 cms or less
  • Located in diverse anatomical regions (except axillar, groin, genital, sole, scalp and flexion or extension areas)

Who cannot join

  • High cardiovascular risk
  • Patients with indication of a different technique

Trial locations and contacts

1 site in 1 country.

Alejandro Cruz, MD contact

5534242197

alejandrocruzsegura@hotmail.com

Claudia Ramos contact

(52) 57245900 ext. 23190

Mexico1 site, 1 recruiting

  • "La Raza" Medical Center. IMSS

    Azcapotzalco, Mexico City, 02990

    Claudia Ramos, (52) 57245900 ext. 23190

    Arturo Jaquez, MD, 55 85359927

    Recruiting

Other trials in Mexico

About this study

Official title: Effectiveness Comparison Between the Use of Skin Micro-grafts vs Meshed Split Thickness Skin Grafts in Cutaneous Defects: A Randomized Controlled Clinical Trial

This is a double-blind randomized controlled clinical trial, that compares the percentage of epithelialization of skin defects using the conventional meshed split thickness skin grafts vs skin micro grafts.

Two techniques will be applied in the same patient. The skin defect will be divided in two parts, and with a randomized method each half of this defect will be assigned to one of the two techniques.

Read the detailed description

Split thickness skin graft is the standard technique in skin defects reconstruction.

The etiology of this problem is diverse (burns, infections, trauma, cancer) however, many times the availability of donor areas are insufficient and morbidity and complications that may arise make prohibitive the use of this technique in many situations.

Skin micro grafts technique consists in using a very small part of skin (0.8x 0.8 mm) and keratinocyte growth-factor solution that allows a 1:50- 1:100 skin expansion. It has many advantages: it can be performed with local anesthesia and donor area is tiny.

The study consists in using the conventional and the new technique in the same patient. The skin defect will be divided in two parts, and with a randomized method each half of this defect will be assigned to one of the two different techniques. The result variable will be the "percentage of epithelialization" and will be compared in the two halves. This variable will be measured at day 14 using clinical and image software methods. The patient and the investigator that record the outcome variable will be blinded to the type of technique.

The investigators will take skin biopsies of two halves and will perform pathology studies.

Conditions
Skin Ulcer, Burns
Being tested
Skin micro Grafts, Standard skin graft
Keywords
skin transplantation, grafting skin
Medical subject headings
Skin Ulcer, Burns

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Skin micro GraftsProcedure or surgery

    Also called Xpansion micro auto grafting system, micro grafts

    0.8 x 0.8 skin micro graft with graft to graft distance of 4 cm (1:50 expansion) bathed with keratinocyte growth factor solution ( 1.5 ml for each 14 square centimeters of wound)

  • Standard skin graftProcedure or surgery

    Also called split thickness skin graft, skin grafting, skin grafts, medium split thickness skin graft

    Standard split thickness (0.3-0.5mm) skin graft

Study groups in NCT02813213
Study groupRoleWhat they receive
Standard skin graftActive comparatorThis group is comprised of patients' wound halves that will receive meshed (1:3) split thickness skin graft (0.3-0.5mm thickness). This half will be covered with a standard "tie over" dressing. The dressing will be removed at day 5, and then it will be removed every 3 days up to the 14th day.
Receives: Procedure: Standard skin graft
Skin micro graftExperimentalThis group is comprised of the patients' wound halves that will receive skin micro grafts. To obtain this grafts the investigators will use "Xpansion micro-autografting" system. They will use 0.8 x 0.8 mm skin grafts with a graft to graft distance of 4mm (1:50 expansion).This half will be covered with a special hydrogel dressing with keratinocyte growth factor (Epilife medium with calcium) 1.5ml for each 14 square centimeters of the wound. This half will be covered with a wet adhesive foam dressing and then it will be covered up with a non-adherent interface dressing (tegaderm). The dressing will be removed at day 5, and then it will be removed every 3 days up to the 14th day. Each time of dressing change only the non-adherent interface dressing will be removed, and the area will be bathed with keratinocyte growth factor solution.
Receives: Procedure: Skin micro Grafts

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of epithelialization

    It will be measured with imaging software (comparing color density) in order to calculate the percentage of epithelialization at day 14 compared with the initial wound area

    Measured: 14th day

Secondary outcomes (2)

  1. Histological study

    Study of the histological characteristics of the skin under microscope

    Measured: 14th day

  2. Clinical percentage of epithelialization

    It will be measured with the "irregular patterns" technique that uses different sizes of geometric patterns in order to calculate the area of a irregular surface. Epithelialization will be compared at day 14 compared with the initial wound area.

    Measured: 14th day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionAug 2018 (estimated)
  4. Study completionSep 2018 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Experimental intervention: skin micro grafts Comparative intervention: Meshed Split Thikness Skin Grafts
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02813213
Sponsor's protocol ID
R-2013-3501-8
Status last verified
Jan 2018
First submitted
21 Jun 2016
Last updated
26 Jan 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Only some data will be shared (age, gender, diagnosis, area defect and epithelialization ratio). Photos will be shared only if the patients give their consent.

Publications

  • Chern PL, Baum CL, Arpey CJ. Biologic dressings: current applications and limitations in dermatologic surgery. Dermatol Surg. 2009 Jun;35(6):891-906. doi: 10.1111/j.1524-4725.2009.01153.x. Epub 2009 Apr 6.

    PubMed 19397669

  • MEEK CP. Successful microdermagrafting using the Meek-Wall microdermatome. Am J Surg. 1958 Oct;96(4):557-8. doi: 10.1016/0002-9610(58)90975-9. No abstract available.

    PubMed 13571547

  • MEEK CP. Extensive severe burn treated with enzymatic debridement and microdermagrafting: case report. Am Surg. 1963 Jan;29:61-4. No abstract available.

    PubMed 13934413

  • TANNER JC Jr, VANDEPUT J, OLLEY JF. THE MESH SKIN GRAFT. Plast Reconstr Surg. 1964 Sep;34:287-92. No abstract available.

    PubMed 14209177

  • Green H, Rheinwald JG, Sun TT. Properties of an epithelial cell type in culture: the epidermal keratinocyte and its dependence on products of the fibroblast. Prog Clin Biol Res. 1977;17:493-500.

    PubMed 928463

  • Rheinwald JG, Green H. Serial cultivation of strains of human epidermal keratinocytes: the formation of keratinizing colonies from single cells. Cell. 1975 Nov;6(3):331-43. doi: 10.1016/s0092-8674(75)80001-8.

    PubMed 1052771

  • Munster AM. Use of cultured epidermal autograft in ten patients. J Burn Care Rehabil. 1992 Jan-Feb;13(1):124-6. doi: 10.1097/00004630-199201000-00028.

    PubMed 1572841

  • Wood FM, Stoner M. Implication of basement membrane development on the underlying scar in partial-thickness burn injury. Burns. 1996 Sep;22(6):459-62. doi: 10.1016/0305-4179(95)00178-6.

    PubMed 8884006

  • Chester DL, Balderson DS, Papini RP. A review of keratinocyte delivery to the wound bed. J Burn Care Rehabil. 2004 May-Jun;25(3):266-75. doi: 10.1097/01.bcr.0000124749.85552.cd.

    PubMed 15273468

  • Lumenta DB, Kamolz LP, Frey M. Adult burn patients with more than 60% TBSA involved-Meek and other techniques to overcome restricted skin harvest availability--the Viennese Concept. J Burn Care Res. 2009 Mar-Apr;30(2):231-42. doi: 10.1097/BCR.0b013e318198a2d6.

    PubMed 19165111

  • Svensjo T, Pomahac B, Yao F, Slama J, Wasif N, Eriksson E. Autologous skin transplantation: comparison of minced skin to other techniques. J Surg Res. 2002 Mar;103(1):19-29. doi: 10.1006/jsre.2001.6331.

    PubMed 11855913

  • Hackl F, Bergmann J, Granter SR, Koyama T, Kiwanuka E, Zuhaili B, Pomahac B, Caterson EJ, Junker JPE, Eriksson E. Epidermal regeneration by micrograft transplantation with immediate 100-fold expansion. Plast Reconstr Surg. 2012 Mar;129(3):443e-452e. doi: 10.1097/PRS.0b013e318241289c.

    PubMed 22373992

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Skin micro Grafts and Standard skin graft in people with Skin Ulcer and Burns, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.

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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 26 Jan 2018. 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 Mexico. 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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Alejandro Cruz, MD (5534242197, alejandrocruzsegura@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of epithelialization (time frame: 14th day). 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 NCT02813213, which also lists 12 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 26 Jan 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in