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

January 20, 2009 updated by: Bispebjerg Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2400
        • Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: continuous smoking
subjects smoke 20 cigarettes per day
Behavioral: Continuous smoking
subjects smoke 20 cigarettes per day
Active Comparator: smoking cessation and NRT
subjects quit smoking and use transdermal nicotine patch
Drug: Transdermal nicotine patch
15mg/16h + 10mg/16h to be used 24h
Other Names:
  • Nicorette patch
Behavioral: Smoking cessation
Placebo Comparator: smoking cessation and placebo patch
subjects quit smoking and use placebo patch
Behavioral: Smoking cessation
Drug: Placebo patch
No Intervention: never smokers
subjects being never smokers and who refrain from smoking

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
wound healing
Time Frame: 1, 4, 8, and 12 weeks
1, 4, 8, and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Collaborators

The Danish Medical Research Council

Investigators

  • Principal Investigator: Lars T Sorensen, MD, Bispebjerg Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2000

Primary Completion (Actual)

December 1, 2000

Study Completion (Actual)

January 1, 2001

Study Registration Dates

First Submitted

January 20, 2009

First Submitted That Met QC Criteria

January 20, 2009

First Posted (Estimate)

January 21, 2009

Study Record Updates

Last Update Posted (Estimate)

January 21, 2009

Last Update Submitted That Met QC Criteria

January 20, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • smokaw_3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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