A Comparison of Monosyn and Monocryl Sutures in Surgical Wounds

NCT ID: NCT00731913

Last Updated: 2015-03-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 48 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2008-03-31

Brief 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).

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.

Conditions

Wounds

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Absorable, monofilament sutures: Monosyn and Monocryl

Intervention Type: OTHER

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.

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.

Absorable, monofilament sutures: Monosyn and Monocryl

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Monofilament, absorbable sutures

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tufts Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Tufts Medical Center

Principal Investigators

Gary S Rogers, MD

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Linh K. Lu, MD, PhD

Role: STUDY_DIRECTOR

Tufts Medical Center

Locations

Tufts Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

8229

Identifier Type: -

Identifier Source: org_study_id