Assessment of the Wound Healing Efficacy and Tolerance of a Medical Device on Wounds in Healthy Subjects.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-13

Study Completion Date

2020-08-17

Brief Summary

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The tested medical device is indicated for the treatment of wounds and small skin injuries. The intention of this study is to evaluate the tolerance and efficacy of the test product by measuring the recovery of the skin barrier after wound produced by suction blister. But also, by validating the accompanying physiological effect of the study product during this recovery.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Healthy adult subjects

It's a randomized intra-individual comparative study with two injured study areas (treated and untreated) for each subject.

The randomization will determine the application side on which the tested product will be applied (RIGHT or LEFT forearm).

Twice daily application on the treated area.

Group Type EXPERIMENTAL

Induction of suction blister

Intervention Type PROCEDURE

For each subject, 2 superficial wounds will be made on the inner aspect of each forearm using the suction blister model.

Transepidermal water loss (TEWL)

Intervention Type OTHER

* At V1, before blister suction use (T0) and after blister withdrawal before product application (T1)
* For subsequent visits, before product application

Macrophotography

Intervention Type OTHER

* At V1, before blister suction use (T0) and after blister withdrawal before product application (T1)
* For subsequent visits, before product application

Wound healing medical device

Intervention Type DEVICE

Twice daily application on superficial wounds

Interventions

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Induction of suction blister

For each subject, 2 superficial wounds will be made on the inner aspect of each forearm using the suction blister model.

Intervention Type PROCEDURE

Transepidermal water loss (TEWL)

* At V1, before blister suction use (T0) and after blister withdrawal before product application (T1)
* For subsequent visits, before product application

Intervention Type OTHER

Macrophotography

* At V1, before blister suction use (T0) and after blister withdrawal before product application (T1)
* For subsequent visits, before product application

Intervention Type OTHER

Wound healing medical device

Twice daily application on superficial wounds

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject with a phototype I, II or III according to the Fitzpatrick scale
* Subject aged between 18 and 45 years included at selection visit
* Subject with absence of infectious diseases (HIV and Hepatitis), confirmed by negative blood test results

Exclusion Criteria

* History of keloids and hypertrophic scars
* Subject with removal of axillary lymph nodes
* Pathology, active skin disease or dermatological condition in progress (psoriasis and/or lichen ruber and/or eczema ...) or presence of dermatological lesions on the inner side of the forearm (solar erythema or dermatosis ...) that may affect the performance of the research or judged incompatible with the realization of the study
* Subject with severe illness (severe infectious disease (e.g. severe flu)), chronic disease or acute evolutionary pathology likely to influence the study results or considered by the investigator hazardous for the subject or incompatible with the study
* Knowledge of Acquired Immunodeficiency Syndrome or Infectious (acute) Hepatitis
* Subject presenting a healing pathology or a pathology with consequences on the healing like the diabetes mellitus (type I and type II)
* Subject with congenital methemoglobinemia or porphyria

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes