Objective: The main objective of our study is to examine whether we can use the IT (as determined by visual irritation grading scale after SLS patch test) to predict HS formation after reduction mammaplasties. The secondary objectives consist of…
ID
Source
Brief title
Condition
- Allergic conditions
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints:
Primary parameter: IT as determined by visual irritation grading scale after
SLS patch test.
Secondary outcome
Secondary parameters: response of PBMC*s to stimulation with LPS, and cytokines
in serum.
Background summary
Rationale: Previous research showed an association between irritation threshold
(IT) and hypertrophic scar (HS) formation. In this study, we want to further
determine this association and examine the possibility to use high IT as a
non-invasive prognostic tool for HS formation.
Study objective
Objective: The main objective of our study is to examine whether we can use the
IT (as determined by visual irritation grading scale after SLS patch test) to
predict HS formation after reduction mammaplasties. The secondary objectives
consist of examining the other predictors of HS formation: cytokine secretion
upon PBMC stimulation, cytokine levels in serum, after SLS patch testing. These
secondary parameters can support our findings with respect to the primary
objective.
Study design
Study design: Observational study with invasive measurements.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Patients that are willing to participate in the
study will undergo a completely non-invasive ambulant skin irritation patch
test. Four different concentrations of SLS and 1 water control will be applied
to the upper arm at time point zero and removed after 2 days, followed by
readout of primary and secondary parameters at day 4. Participation in this
study will require 1 extra hospital visit, 1 telephone call and 1 online
consultation. In previous research, the patch test was found to cause a minor
discomfort. It is a well established method of determining skin irritation
(transient erythema).
Peripheral blood is collected by venipuncture, which is a very low risk
procedure. If the IT determined by patch testing proves to be a good predictive
tool for HS formation, future surgical patients will benefit from this test, by
early interventions to decrease HS formation, or by discouraging patients to
undergo certain operations.
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
Healthy human female volunteers who are prior to undergoing reduction
mammoplasties, are 18 years or older and legally competent.
Exclusion criteria
* Fitzpatrick photo skin type IV or higher
* Skin disease, e.g. psoriasis, pemphigus vulgaris etc.
* Skin lesions, tattoos or substantial hair growth on the patch test site
* Pregnancy or lactation during the patch test
* Topical immunosuppressive treatment of the upper arm in the last 7 days
before the patch test
* Application of skin lotions or ointments on the upper arm in the last 6 weeks
before the patch test
* Abundant exposure of the upper arm to UVR during the patch test
* Systemic antibiotic treatment in the last 2 weeks before the patch test
* Systemic immunosuppressive treatment
* Immunological disorders: infectious disease, immune deficiencies, auto-immune
disorders
* Alcohol or drug abuse
* Smoking
* ASA classification 3 or higher
* Simultaneous participation in another clinical study that could interfere
with the outcome of this study
* Performing physical activities which cause heavy sweating, sauna, swimming or
extreme showers or baths during the patch test
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76519.099.21 |