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

NCT ID: NCT01372488

Last Updated: 2021-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2010-10-31

Brief 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. 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Study group

Study group will be provided with suture removal instructions and suture removal kit and asked to consider removing their own sutures

Group Type: ACTIVE_COMPARATOR

Suture self removal

Intervention Type: PROCEDURE

Suture self removal

Control group

Control group will be asked to have their sutures removed as they normally would (see family doctor or clinic)

Group Type: PLACEBO_COMPARATOR

Suture removal by family doctor or clinic

Intervention Type: PROCEDURE

As above

Interventions

Suture self removal

Suture self removal

Intervention Type: PROCEDURE

Suture removal by family doctor or clinic

As above

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of British Columbia

OTHER

Sponsor Role: collaborator

Fraser Health

OTHER

Sponsor Role: lead

Responsible Party

Peter MacDonald

Emergency Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter J Macdonald, MD

Role: STUDY_DIRECTOR

Royal Columbian Hospital Department of Emergency Medicine, New Westminster, BC, Canada

Locations

Royal Columbian and Eagle Ridge Hospitals

New Westminster, British Columbia, Canada

Countries

Canada

References

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.

Reference Type: RESULT

Other Identifiers

2010-004

Identifier Type: -

Identifier Source: org_study_id