Sutured WoundsNCT01533675
A Comparison Study of the Tensile Strength of Sutures Used in Dermatologic Surgery on the Day of Suture Removal, Following Wound Care With Two Different Products
A study testing Hydrogen peroxide and Saline in people with Sutured Wounds, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sutured Wounds
- What is being tested?
- Hydrogen peroxide and Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
About this study
Official title: A Comparison Study of the Tensile Strength of Sutures Used in Dermatologic Surgery on the Day of Suture Removal, Following Wound Care With Two Different
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.
- Conditions
- Sutured Wounds
- Being tested
- Hydrogen peroxide, Saline
- Keywords
- suture, tensile strength, wound care, saline, hydrogen peroxide, skin closure, wounds, wound healing, wound cleansing, antiseptics
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogen peroxideOther
Once daily topical application of 3% hydrogen peroxide using a cotton-tipped applicator
SalineOther
Once daily topical application of normal saline, using a cotton-tipped applicator
| Study group | Role | What they receive |
|---|---|---|
| Hydrogen peroxide | Experimental | Not described Receives: Other: Hydrogen peroxide |
| Saline | Active comparator | Not described Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startMay 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sutured WoundsStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keyvan Nouri, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533675
- Sponsor's protocol ID
- # 20100301
- Status last verified
- May 2017
- First submitted
- 10 Feb 2012
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 785506Hochberg 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.
PubMed 19465201
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Study of the Tensile Strength of Sutures Used in Dermatologic Surgery on the Day of Suture Removal, Following Wound Care With Two Different
- ClinicalTrials.gov ID
- NCT01533675
- Acronym / sponsor ID
- # 20100301
- Conditions
- Sutured Wounds
- Keywords
- suture, tensile strength, wound care, saline, hydrogen peroxide, skin closure, wounds, wound healing, wound cleansing, antiseptics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 15 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrogen peroxide | Experimental | Other: Hydrogen peroxide |
| Saline | Active comparator | Other: Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrogen peroxideOnce daily topical application of 3% hydrogen peroxide using a cotton-tipped applicator | Other | Hydrogen peroxide |
| SalineOnce daily topical application of normal saline, using a cotton-tipped applicator | Other | Saline |
Primary outcome
Tensile strength of 4-0 nylon sutures
Time frame: 14 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Results publication: PubMed 785506Snyder 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.
- Results publication: PubMed 19465201Hochberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrogen peroxide and Saline in people with Sutured Wounds, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tensile strength of 4-0 nylon sutures (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01533675, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2017.