Surgical WoundNCT02936063
Outcomes Comparing Different Methods of Skin Closure in Patients Undergoing Head and Neck Surgery.
A study testing Surgical staples and Subcuticular sutures in people with Surgical Wound, run by Boston Medical Center at 1 site in United States.
Trial summary
When patients undergo neck dissection surgeries, the current standard of care is to close the skin layer with either metal staples, which are removed a few days post-operatively, or with sutures, which can be absorbable or removed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Wound
- What is being tested?
- Surgical staples and Subcuticular sutures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2018to Mar 2020
- 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
- Able to provide informed consent
- Ability to speak/read English language
- Adult patients (age > 18)
- Willing to have follow-up appointments (per clinical care protocol)
- Both genders
Who cannot join
- Prior radiation therapy to the head and neck region (prior to surgery)
- Prior surgery to the head and neck region (at the judgement of investigator)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
When patients undergo neck dissection surgeries, the current standard of care is to close the skin layer with either metal staples, which are removed a few days post-operatively, or with sutures, which can be absorbable or removed. To date, there is no conclusive data in the literature that definitively suggests one method is better than the other, with regard to wound complications or mature scar cosmesis. Currently, skin closure method is chosen by each individual surgeon, and is based on personal preference, factoring in evaluation of the wound. The goal of the study is to compare the two methods of skin closure, and the measured outcomes the investigators will be looking at are patient satisfaction, wound complications, and mature scar cosmesis. The investigators will be randomizing patients undergoing head and neck surgery to receive either staples or subcuticular sutures, and giving them surveys at their post-operative clinic visits to evaluate the outcomes, to determine if patients perceive one method to be superior to the other.
Read the detailed description
The goal of the study is to evaluate and compare patient perception of two different methods of skin closure following head and neck surgery. Currently, the standard of care includes closing with surgical staples or subcuticular sutures, and is decided at surgeon's discretion. Both methods are used in accordance with the standard of care at Boston Medical Center, depending on individual physician preference. There are also factors that may influence choice of closure at time of surgery, such as operative time, or wound characteristics. For instance, if the operative time was already extending longer than expected, to decrease patient anesthesia time, the surgeon may opt for staples, since they are faster to place than sutures. Also, although a rare scenario, if there was excessive blood loss during the surgery or the surgeon has reason to suspect post-operative hematoma development, they will likely opt for staple closure, to facilitate easy post-operative access to the wound if necessary. In the literature, incidence of hematoma as a post-operative complication to head and neck surgery is stated as 3-4.7%.
There have been various studies in the literature comparing these two skin closure methods for general surgery (abdominal procedures) and obstetrics/gynecological surgeries, with inconclusive outcomes. We found a lack of data in the literature describing head and neck surgeries. Given the different type of wounds, and the often more visible nature of the resulting scars, the investigators believe there is value to accessing patient perception of skin closure in this cohort. Kobayashi et al. conducted a large randomized control trial of 1264 subjects, comparing staples vs. subcuticular sutures after open and laparoscopic elective colorectal cancer surgery. The results of the study showed no significant difference in operative outcomes (wound complications, surgical site infections, post-operative length of stay, scar esthetics). However, staples were found to have a shorter operative time, while sutures resulted in statistically significant higher patient satisfaction. A meta-analysis of 12 studies comparing sutures and staples in caesarian section showed no difference in patient satisfaction or scar cosmesis, but found more wound complications in the staples arm. Much of the existing data are reported from general surgery or obstetrics/gynecology. There is not a lot of literature in otolaryngology or head and neck surgery that evaluates skin closure methods. The importance of cosmetic outcomes and patient satisfaction is particularly important in the field of head and neck surgery, due to the visibility of the scars given their location.
Upon review of the existing literature, there is no definitive data to support either method as superior, with regards to wound complications and outcomes, mature scar cosmesis, or post-operative pain. There is some evidence to suggest that subcuticular suture closure is marginally superior with regards to scar cosmesis, but given that operative time is increased, there is not enough benefit to the patient to change the standard of care. In addition, with the current trend of medicine moving towards patient-reported outcomes, it becomes increasingly important to evaluate patient satisfaction to determine whether there is a superior method. The investigators hypothesize that there will be no statistically significant difference between staple skin closure and subcuticular suture closure, with regards to the primary outcomes of patient satisfaction and mature scar cosmesis.
- Conditions
- Surgical Wound
- Being tested
- Surgical staples, Subcuticular sutures
- Keywords
- Head and neck surgery, Scar cosmesis, Surgical staples, Sutures, Patient satisfaction
- Medical subject headings
- Surgical Wound, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical staplesProcedure or surgery
Closure of surgical wound at skin level with surgical staples
Subcuticular suturesProcedure or surgery
Closure of surgical wound at skin level with subcuticular sutures
| Study group | Role | What they receive |
|---|---|---|
| Surgical staples | Experimental | Skin closure with surgical staples Receives: Procedure: Surgical staples |
| Sutures | Experimental | Skin closure with subcuticular sutures Receives: Procedure: Subcuticular sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient and Observer Scar Assessment Survey (POSAS)
Survey score - to assess for scar cosmesis outcome
Measured: 2 years post-operative
Secondary outcomes (3)
Patient Satisfaction Survey
Survey score - to assess for patient satisfaction
Measured: 2 years post-operative
Wound complications - dehiscence
Wound dehiscence
Measured: 2 years post-operative
Wound complications - infection
Surgical site infections
Measured: 2 years post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startMar 2018 (estimated)
- Primary completionMar 2019 (estimated)
- Study completionMar 2020 (estimated)
Why it stopped: PI left the institution before any participants were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical WoundStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scharukh Jalisi, MD, MA, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936063
- Sponsor's protocol ID
- H-34701
- Status last verified
- Oct 2017
- First submitted
- 29 Jun 2016
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes Comparing Different Methods of Skin Closure in Patients Undergoing Head and Neck Surgery.
- ClinicalTrials.gov ID
- NCT02936063
- Acronym / sponsor ID
- H-34701
- Conditions
- Surgical Wound
- Keywords
- Head and neck surgery, Scar cosmesis, Surgical staples, Sutures, Patient satisfaction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left the institution before any participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Mar 2018 (estimated)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 18 Oct 2016 (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.
When patients undergo neck dissection surgeries, the current standard of care is to close the skin layer with either metal staples, which are removed a few days post-operatively, or with sutures, which can be absorbable or removed. To date, there is no conclusive data in the literature that definitively suggests one method is better than the other, with regard to wound complications or mature scar cosmesis. Currently, skin closure method is chosen by each individual surgeon, and is based on personal preference, factoring in evaluation of the wound. The goal of the study is to compare the two methods of skin closure, and the measured outcomes the investigators will be looking at are patient satisfaction, wound complications, and mature scar cosmesis. The investigators will be randomizing patients undergoing head and neck surgery to receive either staples or subcuticular sutures, and giving them surveys at their post-operative clinic visits to evaluate the outcomes, to determine if patients perceive one method to be superior to the other.
Detailed description
The goal of the study is to evaluate and compare patient perception of two different methods of skin closure following head and neck surgery. Currently, the standard of care includes closing with surgical staples or subcuticular sutures, and is decided at surgeon's discretion. Both methods are used in accordance with the standard of care at Boston Medical Center, depending on individual physician preference. There are also factors that may influence choice of closure at time of surgery, such as operative time, or wound characteristics. For instance, if the operative time was already extending longer than expected, to decrease patient anesthesia time, the surgeon may opt for staples, since they are faster to place than sutures. Also, although a rare scenario, if there was excessive blood loss during the surgery or the surgeon has reason to suspect post-operative hematoma development, they will likely opt for staple closure, to facilitate easy post-operative access to the wound if necessary. In the literature, incidence of hematoma as a post-operative complication to head and neck surgery is stated as 3-4.7%.
There have been various studies in the literature comparing these two skin closure methods for general surgery (abdominal procedures) and obstetrics/gynecological surgeries, with inconclusive outcomes. We found a lack of data in the literature describing head and neck surgeries. Given the different type of wounds, and the often more visible nature of the resulting scars, the investigators believe there is value to accessing patient perception of skin closure in this cohort. Kobayashi et al. conducted a large randomized control trial of 1264 subjects, comparing staples vs. subcuticular sutures after open and laparoscopic elective colorectal cancer surgery. The results of the study showed no significant difference in operative outcomes (wound complications, surgical site infections, post-operative length of stay, scar esthetics). However, staples were found to have a shorter operative time, while sutures resulted in statistically significant higher patient satisfaction. A meta-analysis of 12 studies comparing sutures and staples in caesarian section showed no difference in patient satisfaction or scar cosmesis, but found more wound complications in the staples arm. Much of the existing data are reported from general surgery or obstetrics/gynecology. There is not a lot of literature in otolaryngology or head and neck surgery that evaluates skin closure methods. The importance of cosmetic outcomes and patient satisfaction is particularly important in the field of head and neck surgery, due to the visibility of the scars given their location.
Upon review of the existing literature, there is no definitive data to support either method as superior, with regards to wound complications and outcomes, mature scar cosmesis, or post-operative pain. There is some evidence to suggest that subcuticular suture closure is marginally superior with regards to scar cosmesis, but given that operative time is increased, there is not enough benefit to the patient to change the standard of care. In addition, with the current trend of medicine moving towards patient-reported outcomes, it becomes increasingly important to evaluate patient satisfaction to determine whether there is a superior method. The investigators hypothesize that there will be no statistically significant difference between staple skin closure and subcuticular suture closure, with regards to the primary outcomes of patient satisfaction and mature scar cosmesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical staples | Experimental | Procedure: Surgical staplesSkin closure with surgical staples |
| Sutures | Experimental | Procedure: Subcuticular suturesSkin closure with subcuticular sutures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to provide informed consent
- Ability to speak/read English language
- Adult patients (age > 18)
- Willing to have follow-up appointments (per clinical care protocol)
- Both genders
Key exclusion criteria (3 listed)
- Prior radiation therapy to the head and neck region (prior to surgery)
- Prior surgery to the head and neck region (at the judgement of investigator)
- Pregnancy
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 staplesClosure of surgical wound at skin level with surgical staples | Procedure or surgery | Surgical staples |
| Subcuticular suturesClosure of surgical wound at skin level with subcuticular sutures | Procedure or surgery | Sutures |
Primary outcome
Patient and Observer Scar Assessment Survey (POSAS)
Time frame: 2 years post-operative
Survey score - to assess for scar cosmesis outcome
3 secondary outcomes
Patient Satisfaction Survey
Time frame: 2 years post-operative
Wound complications - dehiscence
Time frame: 2 years post-operative
Wound complications - infection
Time frame: 2 years post-operative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Individual participant dataSharing planned: No
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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.
Scharukh Jalisi, MD, MA principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical staples and Subcuticular sutures in people with Surgical Wound, run by Boston Medical Center 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 5 inclusion and 3 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: withdrawn, as of the sponsor's last update on 6 Oct 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 was withdrawn before enrolling participants, so there are no results.
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?
Patient and Observer Scar Assessment Survey (POSAS) (time frame: 2 years post-operative). 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 6 Oct 2017.