A Comparison of Monosyn and Monocryl Sutures in Surgical Wounds

NCT00731913 | Completed DMC

• 1 other identifier: 8229
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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).

Conditions

Wounds

Keywords

Surgical wounds; Sutures

Outcome Measures

Primary Outcomes (1)

• subjective surgeon preference for both suture types.

  2 weeks

Secondary Outcomes (1)

• Objective handling characteristics as major determinants of surgeon preference for the sutures.

  2 weeks

Study Arms (2)

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.

Other: Absorable, monofilament sutures: Monosyn and Monocryl

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

Interventions

Absorable, monofilament sutures: Monosyn and Monocryl 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.

Also known as: Monofilament, absorbable sutures

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Unable to provide written informed consent

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Wounds and Injuries; Surgical Wound

Interventions

glycolide E-caprolactone copolymer

Study Officials

• Gary S Rogers, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

• Linh K. Lu, MD, PhD

  Tufts Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 7, 2008
• First Posted: August 11, 2008
• Study Start: July 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: March 19, 2015

Record last verified: 2015-03

Locations

US (1)