Clinical trial NCT00731913: A Comparison of Monosyn and Monocryl Sutures in Surgical Wounds
Official title: A Randomized, Prospective Trial Evaluating Surgeon-Preference in Selection of Absorbable Suture Material
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wounds
Keywords: Surgical wounds
Sutures
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2008-08-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with skin lesions requiring surgical removal were eligible for our study.

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.

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

Primary outcomes:
measure: subjective surgeon preference for both suture types.
timeFrame: 2 weeks
Secondary outcomes:
measure: Objective handling characteristics as major determinants of surgeon preference for the sutures.
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Gary S Rogers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tufts Medical Center
name: Linh K. Lu, MD, PhD
role: STUDY_DIRECTOR
References: