NCT01533675

Brief Summary

Sutures are an integral part of surgery and available materials are diverse, as are the options for post-procedure care. Both saline and hydrogen peroxide are commonly used cleansing agents. This study aims to compare the effect of saline and hydrogen peroxide on the tensile strength of 4-0 nylon sutures following removal from a cutaneous surgical wound.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 15, 2012

Completed
Last Updated

May 10, 2017

Status Verified

May 1, 2017

Enrollment Period

1.3 years

First QC Date

February 10, 2012

Last Update Submit

May 9, 2017

Conditions

Keywords

suture, tensile strength, wound care, saline, hydrogen peroxide, skin closure, wounds, wound healing, wound cleansing, antiseptics

Outcome Measures

Primary Outcomes (1)

  • Tensile strength of 4-0 nylon sutures

    The tensile strength was defined as the force required to break the suture, with breaking strength as the maximum strength that a material can withstand when subjected to an applied load, without taking into consideration the cross sectional area. The strength of the sutures was measured using a tensometer.

    14 days

Study Arms (2)

Hydrogen peroxide

EXPERIMENTAL
Other: Hydrogen peroxide

Saline

ACTIVE COMPARATOR
Other: Saline

Interventions

Once daily topical application of 3% hydrogen peroxide using a cotton-tipped applicator

Hydrogen peroxide
SalineOTHER

Once daily topical application of normal saline, using a cotton-tipped applicator

Saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is willing to comply with the informed consent procedures
  • Subject's wound is on the body or scalp
  • Subject will be able to come to the clinic for suture removal on day 14

You may not qualify if:

  • Subject is less than 18 years of age
  • Subject's wound was not closed with 4-0 nylon sutures
  • Subject's wound is on the face
  • Subject plans to apply other topicals to the area under study
  • Subject's suture is removed before or after day 14

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Related Publications (2)

  • Snyder CC. On the history of the suture. Plast Reconstr Surg. 1976 Oct;58(4):401-6. doi: 10.1097/00006534-197610000-00001. No abstract available.

  • Hochberg J, Meyer KM, Marion MD. Suture choice and other methods of skin closure. Surg Clin North Am. 2009 Jun;89(3):627-41. doi: 10.1016/j.suc.2009.03.001.

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Hydrogen PeroxideSodium Chloride

Intervention Hierarchy (Ancestors)

PeroxidesOxidesAnionsIonsElectrolytesInorganic ChemicalsReactive Oxygen SpeciesFree RadicalsOxygen CompoundsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Keyvan Nouri, M.D Professor of Dermatology, Ophthalmology & Otolaryngology, Chief of Dermatology Servic

Study Record Dates

First Submitted

February 10, 2012

First Posted

February 15, 2012

Study Start

May 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

May 10, 2017

Record last verified: 2017-05

Locations