NCT00825851

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2000

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2000

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2000

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2001

Completed
8.1 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 21, 2009

Completed
Last Updated

January 21, 2009

Status Verified

January 1, 2009

Enrollment Period

4 months

First QC Date

January 20, 2009

Last Update Submit

January 20, 2009

Conditions

Wound Healing

Outcome Measures

Primary Outcomes (1)

  • wound healing

    1, 4, 8, and 12 weeks

Study Arms (4)

continuous smoking

ACTIVE COMPARATOR

subjects smoke 20 cigarettes per day

Behavioral: Continuous smoking

smoking cessation and NRT

ACTIVE COMPARATOR

subjects quit smoking and use transdermal nicotine patch

Drug: Transdermal nicotine patchBehavioral: Smoking cessation

smoking cessation and placebo patch

PLACEBO COMPARATOR

subjects quit smoking and use placebo patch

Drug: Placebo patchBehavioral: Smoking cessation

never smokers

NO INTERVENTION

subjects being never smokers and who refrain from smoking

Interventions

Transdermal nicotine patchDRUG

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

Also known as: Nicorette patch
smoking cessation and NRT
Placebo patchDRUG
smoking cessation and placebo patch
Smoking cessationBEHAVIORAL
smoking cessation and NRTsmoking cessation and placebo patch
Continuous smokingBEHAVIORAL

subjects smoke 20 cigarettes per day

continuous smoking

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 12832959RESULT

MeSH Terms

Interventions

Tobacco Use Cessation Devices

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Lars T Sorensen, MD

    Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 20, 2009

First Posted

January 21, 2009

Study Start

August 1, 2000

Primary Completion

December 1, 2000

Study Completion

January 1, 2001

Last Updated

January 21, 2009

Record last verified: 2009-01

Locations

DK(1)