Pain, PostoperativeNCT00186732
Comparison of Subcuticular Suture Versus Surgical Staples for Closure of Pfannenstiel Skin Incisions
A study testing Subcuticular Suture and Surgical Staples in people with Pain, Postoperative and Gynecologic Surgical Procedures, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
This study compares methods of closure for Pfannenstiel incisions commonly used during gynecological and obstetrical surgery. Patients are assigned to closure by either surgical staples or a buried suture. Information is collected on the day of surgery, post-operative day two and at the six-week follow up visit. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pain, Postoperative, Gynecologic Surgical Procedures, Obstetric Surgical Procedures
- What is being tested?
- Subcuticular Suture and Surgical Staples
- Type of treatment
- Surgery or procedure
- How many people
- 288 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2005to Jun 2007
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Undergoing gynecological or obstetrical surgery
- Pfannenstiel skin incision
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pfannenstiel Incision Closure: Subcuticular Suture Versus Surgical Staples
This study compares methods of closure for Pfannenstiel incisions commonly used during gynecological and obstetrical surgery. Patients are assigned to closure by either surgical staples or a buried suture. Information is collected on the day of surgery, post-operative day two and at the six-week follow up visit. The amount of pain and cosmetic result are compared. Infection rates will also be monitored for the two groups.
The study hypothesis is as follows: subcuticular (buried) sutures as compared to surgical staples lead to decreased post-operative pain and improved cosmetic result. Infection rates are similar for both groups.
Read the detailed description
There is little evidence in the literature to guide the choice of closure material for Pfannenstiel laparotomy. Currently this decision is based primarily on physician preference. Physicians differ greatly in their view on which is better. This is based on personal habit and experience and not on scientific evidence. Specifically in the field of obstetrics and gynecology there has only been one randomized trial of approximately 60 patients undergoing cesarean section comparing subcuticular suture vs surgical staples for closure of their Pfannenstiel skin incisions (Frishman et al., 1997). This study showed that Pfannenstiel skin incisions closed with subcuticular closure following cesarean section result in less postoperative pain and are more cosmetically appealing as compared to incisions closed with staples.
This randomized controlled study will compare closure of Pfannenstiel incisions using either subcuticular absorbable suture or surgical staples. It will examine two separate populations - those undergoing cesarean section and those undergoing gynecological surgery such as hysterectomy. These patient groups will be analyzed separately as their demographic characteristics tend to be quite different. The primary outcome will be postoperative pain. Cosmetic result will be a secondary outcome. Cosmesis will be rated both by the patient and the physician. Infection rates are also of great interest although it is unlikely that this study will achieve adequate power to show a statistically significant difference in results. Other outcomes of interest include overall patient satisfaction, total operating room time and length of hospital stay. Patient's body mass index will also be recorded and analyzed to determine whether it affects results in both intervention groups.
There will be a minimum of 144 patients total in the cesarean section group and 144 patients total in the gynecological surgery group - 72 randomized to staples and 72 randomized to subcuticular suture for each group. Thus the entire study will involve approximately 288 patients.
- Being tested
- Subcuticular Suture, Surgical Staples
- Keywords
- wound closure, Pfannenstiel incision, surgical staples, subcuticular suture
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcuticular SutureProcedure or surgery
Surgical StaplesProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Secondary outcomes (4)
Cosmesis
Infection rates
Length of stay OR time
Overall patient satisfaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJul 2005
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Investigators
- Cara A Donnery, MD, Principal investigator, McMaster University Obstetrics and Gynecology ResidentRichard Persadie, MD, Principal investigator, Staff Doctor: St. Joseph's Healthcare, Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00186732
- Sponsor's protocol ID
- 05-2484
- Status last verified
- Aug 2011
- First submitted
- 12 Sep 2005
- Last updated
- 11 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pfannenstiel Incision Closure: Subcuticular Suture Versus Surgical Staples
- ClinicalTrials.gov ID
- NCT00186732
- Acronym / sponsor ID
- 05-2484
- Keywords
- wound closure, Pfannenstiel incision, surgical staples, subcuticular suture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- Jul 2005
- Study completion
- Jun 2007 (actual)
- First posted
- 16 Sep 2005 (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.
This study compares methods of closure for Pfannenstiel incisions commonly used during gynecological and obstetrical surgery. Patients are assigned to closure by either surgical staples or a buried suture. Information is collected on the day of surgery, post-operative day two and at the six-week follow up visit. The amount of pain and cosmetic result are compared. Infection rates will also be monitored for the two groups.
The study hypothesis is as follows: subcuticular (buried) sutures as compared to surgical staples lead to decreased post-operative pain and improved cosmetic result. Infection rates are similar for both groups.
Detailed description
There is little evidence in the literature to guide the choice of closure material for Pfannenstiel laparotomy. Currently this decision is based primarily on physician preference. Physicians differ greatly in their view on which is better. This is based on personal habit and experience and not on scientific evidence. Specifically in the field of obstetrics and gynecology there has only been one randomized trial of approximately 60 patients undergoing cesarean section comparing subcuticular suture vs surgical staples for closure of their Pfannenstiel skin incisions (Frishman et al., 1997). This study showed that Pfannenstiel skin incisions closed with subcuticular closure following cesarean section result in less postoperative pain and are more cosmetically appealing as compared to incisions closed with staples.
This randomized controlled study will compare closure of Pfannenstiel incisions using either subcuticular absorbable suture or surgical staples. It will examine two separate populations - those undergoing cesarean section and those undergoing gynecological surgery such as hysterectomy. These patient groups will be analyzed separately as their demographic characteristics tend to be quite different. The primary outcome will be postoperative pain. Cosmetic result will be a secondary outcome. Cosmesis will be rated both by the patient and the physician. Infection rates are also of great interest although it is unlikely that this study will achieve adequate power to show a statistically significant difference in results. Other outcomes of interest include overall patient satisfaction, total operating room time and length of hospital stay. Patient's body mass index will also be recorded and analyzed to determine whether it affects results in both intervention groups.
There will be a minimum of 144 patients total in the cesarean section group and 144 patients total in the gynecological surgery group - 72 randomized to staples and 72 randomized to subcuticular suture for each group. Thus the entire study will involve approximately 288 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing gynecological or obstetrical surgery
- Pfannenstiel skin incision
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Subcuticular Suture | Procedure or surgery | – |
| Surgical Staples | Procedure or surgery | – |
Primary outcome
Pain
4 secondary outcomes
Cosmesis
Infection rates
Length of stay OR time
Overall patient satisfaction
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 11 Aug 2011.
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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.
Cara A Donnery, MD principal investigator
McMaster University Obstetrics and Gynecology Resident
Richard Persadie, MD principal investigator
Staff Doctor: St. Joseph's Healthcare, Hamilton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcuticular Suture and Surgical Staples in people with Pain, Postoperative and Gynecologic Surgical Procedures, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
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 0 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 11 Aug 2011. 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 Canada. 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?
Pain. 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 11 Aug 2011.