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

Primary Purpose

Wound Healing

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Transdermal nicotine patch

Placebo patch

Smoking cessation

Continuous smoking

About this trial

This is an interventional basic science trial for Wound Healing

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Bispebjerg Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

No Intervention

Arm Label

continuous smoking

smoking cessation and NRT

smoking cessation and placebo patch

never smokers

Arm Description

subjects smoke 20 cigarettes per day

subjects quit smoking and use transdermal nicotine patch

subjects quit smoking and use placebo patch

subjects being never smokers and who refrain from smoking

Outcomes

Primary Outcome Measures

wound healing

Secondary Outcome Measures

Full Information

NCT ID

NCT00825851

First Posted

January 20, 2009

Last Updated

January 20, 2009

Sponsor

Bispebjerg Hospital

Collaborators

The Danish Medical Research Council

1. Study Identification

Unique Protocol Identification Number

NCT00825851

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Completed

Study Start Date

August 2000 (undefined)

Primary Completion Date

December 2000 (Actual)

Study Completion Date

January 2001 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Bispebjerg Hospital

Collaborators

The Danish Medical Research Council

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wound Healing

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

78 (Actual)

8. Arms, Groups, and Interventions

Arm Title

continuous smoking

Arm Type

Active Comparator

Arm Description

subjects smoke 20 cigarettes per day

Arm Title

smoking cessation and NRT

Arm Type

Active Comparator

Arm Description

subjects quit smoking and use transdermal nicotine patch

Arm Title

smoking cessation and placebo patch

Arm Type

Placebo Comparator

Arm Description

subjects quit smoking and use placebo patch

Arm Title

never smokers

Arm Type

No Intervention

Arm Description

subjects being never smokers and who refrain from smoking

Intervention Type

Drug

Intervention Name(s)

Transdermal nicotine patch

Other Intervention Name(s)

Nicorette patch

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo patch

Intervention Type

Behavioral

Intervention Name(s)

Smoking cessation

Intervention Type

Behavioral

Intervention Name(s)

Continuous smoking

Intervention Description

subjects smoke 20 cigarettes per day

Primary Outcome Measure Information:

Title

wound healing

Time Frame

1, 4, 8, and 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lars T Sorensen, MD

Organizational Affiliation

Bispebjerg Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bispebjerg Hospital

City

Copenhagen

ZIP/Postal Code

2400

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

12832959

Citation

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.

Results Reference

result

Learn more about this trial

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

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