SurgeryPhase 4NCT00273715
Study of Sutures Versus Staples for Skin Closure After Surgical Procedures of Hip
A Phase 4 study testing Surgical wound closure techniques and Surgical wound closure techniques (Comparator) in people with Surgery, run by University of Kentucky at 1 site in United States.
Trial summary
Skin closure either by sutures or staples is required after any surgical procedure of the hip. The purpose of this study is to compare the amount of drainage between patients who have had either staples or sutures placed for skin closure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- Surgical wound closure techniques and Surgical wound closure techniques (Comparator)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Oct 2008
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must be 18 years of age or greater
- The patient must need an operative procedure of hip
Who cannot join
- Patients who are unable to undergo surgery.
- Patients who have a history of clotting or bleeding abnormalities.
- Patients who have arthroscopic hip surgery.
- Patients who have infections.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536
About this study
Official title: A Comparative Randomized Efficacy Study of Sutures Versus Staples in Hip Surgical Procedures
Skin closure either by sutures or staples is required after any surgical procedure of the hip.
The purpose of this study is to compare the amount of drainage between patients who have had either staples or sutures placed for skin closure.
Read the detailed description
Skin closure either by sutures or staples is required after any surgical procedure of the hip.
The purpose of this study is to compare the amount of drainage between patients who have had either staples or sutures placed for skin closure.
- Conditions
- Surgery
- Being tested
- Surgical wound closure techniques, Surgical wound closure techniques (Comparator)
- Keywords
- Comparative, Randomized, Suture, Staples, surgical, Skin, Surgical procedures, operative, Orthopedics, Joint, hip, Surgical procedures of Hip, Operative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical wound closure techniquesProcedure or surgery
Subjects will be randomized to either receive sutures or staples during the surical procedure to close the incision
Surgical wound closure techniques (Comparator)Procedure or surgery
Subjects will be randomized to either receive sutures or staples during the surical procedure to close the incision
| Study group | Role | What they receive |
|---|---|---|
| Staples | No intervention | Not described Receives: Procedure: Surgical wound closure techniques; Procedure: Surgical wound closure techniques (Comparator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of drainage from skin closure site
Measured: up to 5 days following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startDec 2005
- Primary completionSep 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Selby, MD, Principal investigator, University of Kentucky Department of Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00273715
- Sponsor's protocol ID
- 05-0715-F2L
- Status last verified
- Jul 2013
- First submitted
- 5 Jan 2006
- Last updated
- 31 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Randomized Efficacy Study of Sutures Versus Staples in Hip Surgical Procedures
- ClinicalTrials.gov ID
- NCT00273715
- Acronym / sponsor ID
- 05-0715-F2L
- Conditions
- Surgery
- Keywords
- Comparative, Randomized, Suture, Staples, surgical, Skin, Surgical procedures, operative, Orthopedics, Joint, hip
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 9 Jan 2006 (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.
Skin closure either by sutures or staples is required after any surgical procedure of the hip.
The purpose of this study is to compare the amount of drainage between patients who have had either staples or sutures placed for skin closure.
Detailed description
Skin closure either by sutures or staples is required after any surgical procedure of the hip.
The purpose of this study is to compare the amount of drainage between patients who have had either staples or sutures placed for skin closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Staples | No intervention | Procedure: Surgical wound closure techniques, Procedure: Surgical wound closure techniques (Comparator) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The patient must be 18 years of age or greater
- The patient must need an operative procedure of hip
Key exclusion criteria (4 listed)
- Patients who are unable to undergo surgery.
- Patients who have a history of clotting or bleeding abnormalities.
- Patients who have arthroscopic hip surgery.
- Patients who have infections.
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 |
|---|---|---|
| Surgical wound closure techniquesSubjects will be randomized to either receive sutures or staples during the surical procedure to close the incision | Procedure or surgery | Staples |
| Surgical wound closure techniques (Comparator)Subjects will be randomized to either receive sutures or staples during the surical procedure to close the incision | Procedure or surgery | Staples |
Primary outcome
Amount of drainage from skin closure site
Time frame: up to 5 days following surgery
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 31 Jul 2013.
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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.
Jeffrey Selby, MD principal investigator
University of Kentucky Department of Orthopaedic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Surgical wound closure techniques and Surgical wound closure techniques (Comparator) in people with Surgery, run by University of Kentucky 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 2 inclusion and 4 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 31 Jul 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Amount of drainage from skin closure site (time frame: up to 5 days following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2013.