Suture RemovalNCT01372488
Are Patients Willing and Capable of Removing Their Own Non-absorbable Sutures
A study testing Suture self removal and Suture removal by family doctor or clinic in people with Suture Removal, run by Fraser Health at 1 site in Canada.
Trial summary
1. Hypothesis If patients who are sutured with non-absorbable sutures in the Emergency Department (ED) are provided with the proper equipment and knowledge on how to remove their own sutures, they will be willing and capable of removing their own sutures. 2. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Suture Removal
- What is being tested?
- Suture self removal and Suture removal by family doctor or clinic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2010to Oct 2010
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients 19 years and older that have wounds sutured in the ER with non-absorbable sutures
Who cannot join
- Inability to give consent secondary to alcohol, drugs or failure to speak English
- Complicated lacerations or lacerations which require close medical supervision
- Lacerations that are inaccessible to the patient (ie. scalp, back or buttock lacerations)
- Inability to contact patient by telephone for follow-up (no telephone, patient travelling out of country etc.)
- Patients who are immunocompromised, have diabetes mellitus or are on steroid medications
Trial locations and contacts
1 site in 1 country.
Canada1 site
Royal Columbian and Eagle Ridge Hospitals
New Westminster, British Columbia
About this study
- Hypothesis If patients who are sutured with non-absorbable sutures in the Emergency Department (ED) are provided with the proper equipment and knowledge on how to remove their own sutures, they will be willing and capable of removing their own sutures.
- Primary and Secondary Questions
Primary Question What number of patients in the study group will successfully remove their own sutures if they are provided with the equipment and information on how to do so compared with a control group who are treated and advised in the usual fashion? (follow up with family doctor or local medical clinic for suture removal)
Read more
Secondary Questions
- Number of complications related to self removal of sutures as compared to traditional treatment. Complications measured were wound infections, dehiscence and prolonged bleeding (>30 min)
- Number of physician visits related to self removal of sutures as compared to traditional treatment.
- Patient satisfaction and comfort level related to self removal of sutures as compared with traditional treatment.
Read the detailed description
Introduction/Background:
Patients who are sutured with non-absorbable sutures in the Emergency Department are asked to follow up with their family doctor or local medical clinic for suture removal. Suture removal, especially for simple lacerations is easy to do. Given the proper instructions and equipment suture removal could be done by the patient or a family member.
Objectives:
Are patients willing and capable of removing their own non-absorbable sutures? How many patients can successfully self remove their own sutures if given the proper equipment and instructions as compared with patients who are not given equipment and instructions? Would patient self removal result in less physician visits related to sutured wounds? What would be the complication rate for self removal of sutures be? Specific complications were wound infection, dehiscence and prolonged bleeding? Would patients be satisfied and comfortable in taking out their own sutures?
Methods:
Patients who are sutured with non absorbable sutures in the emergency department will be randomly enrolled into either of two groups. One group will receive wound care instructions alone. The second group will be given wound care instructions, a suture removal kit and instructions regarding self-removal to take home. Both groups will be contacted by telephone 14 days after suturing and asked questions concerning who removed their sutures, number of physician visits, time loss from work related to suture removal and complications related to sutures or suture removal. Questions regarding patient satisfaction with respect to self removal of sutures will also be asked.
- Conditions
- Suture Removal
- Being tested
- Suture self removal, Suture removal by family doctor or clinic
- Keywords
- Suture self removal, non-absorbable sutures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suture self removalProcedure or surgery
Suture self removal
Suture removal by family doctor or clinicProcedure or surgery
As above
| Study group | Role | What they receive |
|---|---|---|
| Study group | Active comparator | Study group will be provided with suture removal instructions and suture removal kit and asked to consider removing their own sutures Receives: Procedure: Suture self removal |
| Control group | Placebo comparator | Control group will be asked to have their sutures removed as they normally would (see family doctor or clinic) Receives: Procedure: Suture removal by family doctor or clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Are patients willing and capable of removing their own non-absorbable sutures?
What number of patients in the study group will successfully remove their own sutures if they are provided with the equipment and information on how to do so compared with a control group who are treated and advised in the usual fashion? (follow up with family doctor or local medical clinic for suture removal)
Measured: 3 months
Secondary outcomes (3)
Complications related to self removal of sutures
Number of complications related to self removal of sutures as compared to traditional treatment were measured. Complications measured were wound infections, dehiscence and prolonged bleeding (>30 min)
Measured: 3 months
Physician Visits Related to Suture Self Removal
Number of physician visits related to self removal of sutures as compared to traditional treatment.
Measured: 3 months
Patient Comfort and Satisfaction with Self-Removal of Sutures
Patient satisfaction and comfort level related to self removal of sutures as compared with traditional treatment. Measures used were a survey with a 5 choice answer.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study startApr 2010
- Primary completionSep 2010
- Study completionOct 2010
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 Suture RemovalStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraser Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia
- Responsible party
- Principal investigator, Peter MacDonald, Fraser Health
- Investigators
- Peter J Macdonald, MD, Study director, Royal Columbian Hospital Department of Emergency Medicine, New Westminster, BC, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01372488
- Sponsor's protocol ID
- 2010-004
- Status last verified
- Oct 2021
- First submitted
- 9 Feb 2010
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Albert, M., Daly, A., Krueger, J., Krueger, K., Meeusen, C., Vogelheim, C., & Jones, J. (2009). 421: Self-removal of sutures by emergency department patients. Annals of Emergency Medicine, 54(3S), 133-133.
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Patients Willing and Capable of Removing Their Own Non-absorbable Sutures
- ClinicalTrials.gov ID
- NCT01372488
- Acronym / sponsor ID
- 2010-004
- Conditions
- Suture Removal
- Keywords
- Suture self removal, non-absorbable sutures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Fraser HealthUniversity, hospital or other
- Collaborators
- University of British Columbia
- Study start
- Apr 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 14 Jun 2011 (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.
- Hypothesis If patients who are sutured with non-absorbable sutures in the Emergency Department (ED) are provided with the proper equipment and knowledge on how to remove their own sutures, they will be willing and capable of removing their own sutures.
- Primary and Secondary Questions
Primary Question What number of patients in the study group will successfully remove their own sutures if they are provided with the equipment and information on how to do so compared with a control group who are treated and advised in the usual fashion? (follow up with family doctor or local medical clinic for suture removal)
Secondary Questions
- Number of complications related to self removal of sutures as compared to traditional treatment. Complications measured were wound infections, dehiscence and prolonged bleeding (>30 min)
- Number of physician visits related to self removal of sutures as compared to traditional treatment.
- Patient satisfaction and comfort level related to self removal of sutures as compared with traditional treatment.
Detailed description
Introduction/Background:
Patients who are sutured with non-absorbable sutures in the Emergency Department are asked to follow up with their family doctor or local medical clinic for suture removal. Suture removal, especially for simple lacerations is easy to do. Given the proper instructions and equipment suture removal could be done by the patient or a family member.
Objectives:
Are patients willing and capable of removing their own non-absorbable sutures? How many patients can successfully self remove their own sutures if given the proper equipment and instructions as compared with patients who are not given equipment and instructions? Would patient self removal result in less physician visits related to sutured wounds? What would be the complication rate for self removal of sutures be? Specific complications were wound infection, dehiscence and prolonged bleeding? Would patients be satisfied and comfortable in taking out their own sutures?
Methods:
Patients who are sutured with non absorbable sutures in the emergency department will be randomly enrolled into either of two groups. One group will receive wound care instructions alone. The second group will be given wound care instructions, a suture removal kit and instructions regarding self-removal to take home. Both groups will be contacted by telephone 14 days after suturing and asked questions concerning who removed their sutures, number of physician visits, time loss from work related to suture removal and complications related to sutures or suture removal. Questions regarding patient satisfaction with respect to self removal of sutures will also be asked.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Active comparator | Procedure: Suture self removalStudy group will be provided with suture removal instructions and suture removal kit and asked to consider removing their own sutures |
| Control group | Placebo comparator | Procedure: Suture removal by family doctor or clinicControl group will be asked to have their sutures removed as they normally would (see family doctor or clinic) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients 19 years and older that have wounds sutured in the ER with non-absorbable sutures
Key exclusion criteria (5 listed)
- Inability to give consent secondary to alcohol, drugs or failure to speak English
- Complicated lacerations or lacerations which require close medical supervision
- Lacerations that are inaccessible to the patient (ie. scalp, back or buttock lacerations)
- Inability to contact patient by telephone for follow-up (no telephone, patient travelling out of country etc.)
- Patients who are immunocompromised, have diabetes mellitus or are on steroid medications
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 |
|---|---|---|
| Suture self removalSuture self removal | Procedure or surgery | Study group |
| Suture removal by family doctor or clinicAs above | Procedure or surgery | Control group |
Primary outcome
Are patients willing and capable of removing their own non-absorbable sutures?
Time frame: 3 months
What number of patients in the study group will successfully remove their own sutures if they are provided with the equipment and information on how to do so compared with a control group who are treated and advised in the usual fashion? (follow up with family doctor or local medical clinic for suture removal)
3 secondary outcomes
Complications related to self removal of sutures
Time frame: 3 months
Physician Visits Related to Suture Self Removal
Time frame: 3 months
Patient Comfort and Satisfaction with Self-Removal of Sutures
Time frame: 3 months
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 12 Oct 2021.
- Results publicationAlbert, M., Daly, A., Krueger, J., Krueger, K., Meeusen, C., Vogelheim, C., & Jones, J. (2009). 421: Self-removal of sutures by emergency department patients. Annals of Emergency Medicine, 54(3S), 133-133.
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.
Peter J Macdonald, MD study director
Royal Columbian Hospital Department of Emergency Medicine, New Westminster, BC, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suture self removal and Suture removal by family doctor or clinic in people with Suture Removal, run by Fraser Health at 1 site in Canada.
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 5 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 12 Oct 2021. 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 Canada. 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?
Are patients willing and capable of removing their own non-absorbable sutures? (time frame: 3 months). 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 NCT01372488, 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 12 Oct 2021; AzTrials last refreshed its copy on 8 Nov 2026.