- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01372488
Are Patients Willing and Capable of Removing Their Own Non-absorbable Sutures
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.
Study Overview
Status
Conditions
Intervention / 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
-
New Westminster, British Columbia, Canada
- Royal Columbian and Eagle Ridge Hospitals
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients 19 years and older that have wounds sutured in the ER with non-absorbable sutures
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Study group
Study group will be provided with suture removal instructions and suture removal kit and asked to consider removing their own sutures
|
Suture self removal
|
Placebo Comparator: Control group
Control group will be asked to have their sutures removed as they normally would (see family doctor or clinic)
|
As above
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complications related to self removal of sutures
Time Frame: 3 months
|
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)
|
3 months
|
Physician Visits Related to Suture Self Removal
Time Frame: 3 months
|
Number of physician visits related to self removal of sutures as compared to traditional treatment.
|
3 months
|
Patient Comfort and Satisfaction with Self-Removal of Sutures
Time Frame: 3 months
|
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.
|
3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Peter J Macdonald, MD, Royal Columbian Hospital Department of Emergency Medicine, New Westminster, BC, Canada
Publications and helpful links
General 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 record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2010-004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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