A Comparison of Monosyn and Monocryl Sutures in Surgical Wounds

This study has been completed.
Sponsor:
Information provided by:
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT00731913
First received: August 7, 2008
Last updated: August 8, 2008
Last verified: August 2008
  Purpose

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


Condition Intervention
Wounds
Other: Absorable, monofilament sutures: Monosyn and Monocryl

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Randomized, Prospective Trial Evaluating Surgeon-Preference in Selection of Absorbable Suture Material

Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • subjective surgeon preference for both suture types. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective handling characteristics as major determinants of surgeon preference for the sutures. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: July 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1, 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.
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.
Other Name: Monofilament, absorbable sutures

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients with skin lesions requiring surgical removal were eligible for our study.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00731913

Locations
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
Investigators
Principal Investigator: Gary S Rogers, MD Tufts Medical Center
Study Director: Linh K. Lu, MD, PhD Tufts Medical Center
  More Information

No publications provided

Responsible Party: Gary Rogers, Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00731913     History of Changes
Other Study ID Numbers: 8229
Study First Received: August 7, 2008
Last Updated: August 8, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts Medical Center:
Surgical wounds
Sutures

ClinicalTrials.gov processed this record on July 29, 2014