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Are Patients Willing and Capable of Removing Their Own Non-absorbable Sutures

This study has been completed.
Sponsor:
Collaborator:
University of British Columbia
Information provided by:
Fraser Health
ClinicalTrials.gov Identifier:
NCT01372488
First received: February 9, 2010
Last updated: June 22, 2011
Last verified: June 2011
History of Changes
  Purpose

  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. 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

  1. 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)
  2. Number of physician visits related to self removal of sutures as compared to traditional treatment.
  3. Patient satisfaction and comfort level related to self removal of sutures as compared with traditional treatment.

Condition Intervention
Suture Removal
 Procedure: Suture self removal
Procedure: Suture removal by family doctor or clinic

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Are Patients Willing and Capable of Removing Their Own Non-absorbable Sutures

Further study details as provided by Fraser Health:

Primary Outcome Measures:
  • Are patients willing and capable of removing their own non-absorbable sutures? [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Complications related to self removal of sutures [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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)

  • Physician Visits Related to Suture Self Removal [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Number of physician visits related to self removal of sutures as compared to traditional treatment.

  • Patient Comfort and Satisfaction with Self-Removal of Sutures [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 160
Study Start Date: April 2010
Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Procedure: Suture self removal
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)
 Procedure: Suture removal by family doctor or clinic
As above

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01372488

Locations
Canada, British Columbia
Royal Columbian and Eagle Ridge Hospitals
New Westminster, British Columbia, Canada
Sponsors and Collaborators
Fraser Health
University of British Columbia
Investigators
Study Director: Peter J Macdonald, MD Royal Columbian Hospital Department of Emergency Medicine, New Westminster, BC, Canada
  More Information

No publications provided

Responsible Party: Dr. Peter Macdonald, Emergency Physician Royal Columbian and Eagle Ridge Hospitals
ClinicalTrials.gov Identifier: NCT01372488     History of Changes
Other Study ID Numbers: 2010-004
Study First Received: February 9, 2010
Last Updated: June 22, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Fraser Health:
Suture self removal
non-absorbable sutures

ClinicalTrials.gov processed this record on May 23, 2013