A Comparison of Monosyn and Monocryl Sutures in Surgical Wounds

Wounds Clinical Trial

Official title:

A Randomized, Prospective Trial Evaluating Surgeon-Preference in Selection of Absorbable Suture Material

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00731913
• Other study ID #: 8229
• Status: Completed
• Phase: N/A
• First received: August 7, 2008
• Last updated: March 17, 2015
• Start date: July 2007
• Est. completion date: March 2008

Study information

• Verified date: March 2015
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

To better understand surgeon preference when using synthetic, absorbable, monofilament suture by comparing two similar appearing FDA-approved sutures, Monosyn (Aesculap) and Monocryl (Ethicon).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Wounds

Intervention

Other:
• Absorable, monofilament sutures: Monosyn and Monocryl
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.

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	subjective surgeon preference for both suture types.		2 weeks	No
Secondary	Objective handling characteristics as major determinants of surgeon preference for the sutures.		2 weeks	No