Effect of Smoking, Abstention and Nicotine Replacement Therapy on Wound Healing

NCT ID: NCT00825851

Last Updated: 2009-01-21

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

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-08-31

Study Completion Date

2001-01-31

Brief Summary

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The aim was to determine the wound healing capacity in healthy never smokers and smokers who continue to smoke, or quit smoking using transdermal nicotine patch versus placebo patch.

Detailed Description

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Two wound healing models were applied: the excisional skin biopsy model to study wound histology and the suction blister model to study epidermal regeneration and skin transudate. In addition blood sampling was made to validate compliance to the study arms and to study systemic markers of collagen metabolism and oxidative stress. In addition, wound infections and wound ruptures were recorded post hoc as complications to the excisional skin biopsy model were not expected to occur.

Conditions

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Wound Healing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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continuous smoking

subjects smoke 20 cigarettes per day

Group Type ACTIVE_COMPARATOR

Continuous smoking

Intervention Type BEHAVIORAL

subjects smoke 20 cigarettes per day

smoking cessation and NRT

subjects quit smoking and use transdermal nicotine patch

Group Type ACTIVE_COMPARATOR

Transdermal nicotine patch

Intervention Type DRUG

15mg/16h + 10mg/16h to be used 24h

Smoking cessation

Intervention Type BEHAVIORAL

smoking cessation and placebo patch

subjects quit smoking and use placebo patch

Group Type PLACEBO_COMPARATOR

Placebo patch

Intervention Type DRUG

Smoking cessation

Intervention Type BEHAVIORAL

never smokers

subjects being never smokers and who refrain from smoking

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Transdermal nicotine patch

15mg/16h + 10mg/16h to be used 24h

Intervention Type DRUG

Placebo patch

Intervention Type DRUG

Smoking cessation

Intervention Type BEHAVIORAL

Continuous smoking

subjects smoke 20 cigarettes per day

Intervention Type BEHAVIORAL

Other Intervention Names

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Nicorette patch

Eligibility Criteria

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Inclusion Criteria

* daily smokers smoking between 15-25 cigarettes per day and never smokers

Exclusion Criteria

* chronic medical disease
* atopic dermatitis or other skin disease
* pregnancy
* menopause
* allergy to dressings or patches
* current or recent medication with corticosteroids or NSAID
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Danish Medical Research Council

OTHER

Sponsor Role collaborator

Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Bispebjerg Hospital

Principal Investigators

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Lars T Sorensen, MD

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Locations

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Bispebjerg Hospital

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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Sorensen LT, Karlsmark T, Gottrup F. Abstinence from smoking reduces incisional wound infection: a randomized controlled trial. Ann Surg. 2003 Jul;238(1):1-5. doi: 10.1097/01.SLA.0000074980.39700.31.

Reference Type RESULT
PMID: 12832959 (View on PubMed)

Other Identifiers

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smokaw_3

Identifier Type: -

Identifier Source: org_study_id

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