A Comparison of Monosyn and Monocryl Sutures in Surgical Wounds
A Randomized, Prospective Trial Evaluating Surgeon-Preference in Selection of Absorbable Suture Material
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Physicians have used suture to close wounds for at least 4,000 years. Archaeological records from ancient Egypt show that Egyptians used linen and animal sinew to close wounds. In ancient India, physicians used the pincers of beetles or ants to staple wounds shut. They then cut the insects' bodies off, leaving their jaws (staples) in place. Other natural materials used to close wounds include flax, hair, grass, cotton, silk, pig bristles, and animal gut.
The fundamental principles of wound closure have changed little over 4,000 years. Successful closure of wound involves surgical techniques coupled with knowledge of the physical characteristics and handling of the suture and needle. The selection of proper suture material in closing any surgical defect is important in wound healing, minimizing infection, and achieving optimal cosmetic and functional results.
A great deal of progress has been made since Egyptian times with regard to suture materials and manufacturing processes. Today, sutures are available with a wide variety of characteristics, configuration, manipulability, coefficient of friction, solubility, strength, and immunogenic properties. Yet, sutures are currently rather crudely classified based on a numeric scale according to diameter and tensile strength; descending from 10 to 1, and then descending again from 1-0 to 12-0. This study aims to explore the factors that are important to a surgeon when choosing sutures via evaluating surgeon preference for two types of synthetic, absorbable, monofilament sutures: Monosyn and Monocryl. We hope to initiate a more nuanced exploration of how suture characteristics influence surgeon preference, beyond filament type and size, and how makers of suture may better report and represent these factors.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02111
- Tufts Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Specific eligibility requirements included surgical defects that are linear, without curvature, 3.0 cm in length or greater and extending into the subcutis or fascia.
- All surgical defects were required to be closed primarily (that is without flaps or grafts) and had equal skin integrity on both halves of their surgical defects.
- All subjects were capable of providing written informed consent.
Exclusion Criteria:
- Unable to provide written informed consent
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1
Subjects with skin lesions requiring surgical excision and repair.
One half of the each wound received Monocryl suture and the other half received Monosyn suture.
|
Subjects were randomized to Monosyn vs. Monocryl suture arms.
The designated skin lesion was removed surgically.
The surgical repair of the defect was performed by dividing the wound in half by a single Prolene suture.
The appropriate suture was opened by the Study Coordinator and passed sterilely to the surgical technician.
The surgical technician loaded the suture, and passed it in a blinded fashion to the physician who closed the appropriate half of the surgical defect.
One half of the wound was closed with one suture and the other half was closed with the other suture.
Each patient served as their own control, as both sutures were used in each study patient.
Other Names:
|
|
2
Subjects with skin lesions requiring surgical excision and repair.
One half of the each wound received Monocryl suture and the other half received Monosyn suture.
|
Subjects were randomized to Monosyn vs. Monocryl suture arms.
The designated skin lesion was removed surgically.
The surgical repair of the defect was performed by dividing the wound in half by a single Prolene suture.
The appropriate suture was opened by the Study Coordinator and passed sterilely to the surgical technician.
The surgical technician loaded the suture, and passed it in a blinded fashion to the physician who closed the appropriate half of the surgical defect.
One half of the wound was closed with one suture and the other half was closed with the other suture.
Each patient served as their own control, as both sutures were used in each study patient.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
subjective surgeon preference for both suture types.
Time Frame: 2 weeks
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Objective handling characteristics as major determinants of surgeon preference for the sutures.
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gary S Rogers, MD, Tufts Medical Center
- Study Director: Linh K. Lu, MD, PhD, Tufts Medical Center
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 (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8229
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.