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

What Was Tested

In this not phased trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

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.

It had four arms (groups): continuous smoking (active comparator), smoking cessation and NRT (active comparator), smoking cessation and placebo patch (placebo comparator) and never smokers (no intervention).

Subjects smoke 20 cigarettes per day.

Subjects quit smoking and use transdermal nicotine patch.

Subjects quit smoking and use placebo patch.

The registry classes the interventions as behavioral and drug.

More on the Plan

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.

Who Took Part

78 actual participants took part.

It was open to people of any sex aged from 18 years up to 40 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Daily smokers smoking between 15-25 cigarettes per day and never smokers.

The full record lists 1 inclusion and 6 exclusion criteria; among the exclusions: atopic dermatitis or other skin disease; allergy to dressings or patches; current or recent medication with corticosteroids or nsaid.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Because people in this Therapeutic nicotine (patch, non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Therapeutic nicotine (patch, non-peptide), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2000-08 with completion listed for 2000-12.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: wound healing (time frame: 1, 4, 8, and 12 weeks).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 78 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.