Wound HealingNCT00825851
Effect of Smoking, Abstention and Nicotine Replacement Therapy on Wound Healing
A study testing Transdermal nicotine patch, Smoking cessation and Continuous smoking in people with Wound Healing, run by Bispebjerg Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Healing
- What is being tested?
- Transdermal nicotine patch, Smoking cessation and Continuous smoking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2000to Jan 2001
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- daily smokers smoking between 15-25 cigarettes per day and never smokers
Who cannot join
- chronic medical disease
- atopic dermatitis or other skin disease
- pregnancy
- menopause
- allergy to dressings or patches
- current or recent medication with corticosteroids or NSAID
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Wound Healing
- Being tested
- Transdermal nicotine patch, Placebo patch, Smoking cessation, Continuous smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal nicotine patchDrug
Also called Nicorette patch
15mg/16h + 10mg/16h to be used 24h
Placebo patchDrug
Smoking cessationBehavioural
Continuous smokingBehavioural
subjects smoke 20 cigarettes per day
| Study group | Role | What they receive |
|---|---|---|
| continuous smoking | Active comparator | subjects smoke 20 cigarettes per day Receives: Behavioral: Continuous smoking |
| smoking cessation and NRT | Active comparator | subjects quit smoking and use transdermal nicotine patch Receives: Drug: Transdermal nicotine patch; Behavioral: Smoking cessation |
| smoking cessation and placebo patch | Placebo comparator | subjects quit smoking and use placebo patch Receives: Drug: Placebo patch; Behavioral: Smoking cessation |
| never smokers | No intervention | subjects being never smokers and who refrain from smoking |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound healing
Measured: 1, 4, 8, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startAug 2000
- Primary completionDec 2000
- Study completionJan 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Medical Research Council
- Investigators
- Lars T Sorensen, MD, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825851
- Sponsor's protocol ID
- smokaw_3
- Status last verified
- Jan 2009
- First submitted
- 20 Jan 2009
- Last updated
- 21 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12832959
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Smoking, Abstention and Nicotine Replacement Therapy on Wound Healing
- ClinicalTrials.gov ID
- NCT00825851
- Acronym / sponsor ID
- smokaw_3
- Conditions
- Wound Healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- The Danish Medical Research Council
- Study start
- Aug 2000
- Primary completion
- Dec 2000 (actual)
- Study completion
- Jan 2001 (actual)
- First posted
- 21 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| continuous smoking | Active comparator | Behavioral: Continuous smokingsubjects smoke 20 cigarettes per day |
| smoking cessation and NRT | Active comparator | Drug: Transdermal nicotine patch, Behavioral: Smoking cessationsubjects quit smoking and use transdermal nicotine patch |
| smoking cessation and placebo patch | Placebo comparator | Drug: Placebo patch, Behavioral: Smoking cessationsubjects quit smoking and use placebo patch |
| never smokers | No intervention | –subjects being never smokers and who refrain from smoking |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- daily smokers smoking between 15-25 cigarettes per day and never smokers
Key exclusion criteria (6 listed)
- chronic medical disease
- atopic dermatitis or other skin disease
- pregnancy
- menopause
- allergy to dressings or patches
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdermal nicotine patchAlso: Nicorette patch15mg/16h + 10mg/16h to be used 24h | Drug | smoking cessation and NRT |
| Placebo patch | Drug | smoking cessation and placebo patch |
| Smoking cessation | Behavioural | smoking cessation and NRT, smoking cessation and placebo patch |
| Continuous smokingsubjects smoke 20 cigarettes per day | Behavioural | continuous smoking |
Primary outcome
wound healing
Time frame: 1, 4, 8, and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2009.
- Results publication: PubMed 12832959Sorensen 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.
Related trials for Wound Healing
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
RecruitingObservational study
A Post-Market Assessment of the Safety and Performance of the TriClip™ System
Tricuspid Regurgitation (TR)
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruiting
Effect of a Novel Episiotomy Repair Simulator on Midwifery Students' Self-Efficacy and Anxiety
Episiotomy Repair Training
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars T Sorensen, MD principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transdermal nicotine patch, Smoking cessation and Continuous smoking in people with Wound Healing, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound healing (time frame: 1, 4, 8, and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00825851, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2009.