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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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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.

United States1 site
  • Boston Medical Center

    Boston, Massachusetts, 02118

Other trials in United States

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 groups in NCT02936063
Study groupRoleWhat they receive
Surgical staplesExperimentalSkin closure with surgical staples
Receives: Procedure: Surgical staples
SuturesExperimentalSkin 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.

  1. Patient and Observer Scar Assessment Survey (POSAS)

    Survey score - to assess for scar cosmesis outcome

    Measured: 2 years post-operative

Secondary outcomes (3)
  1. Patient Satisfaction Survey

    Survey score - to assess for patient satisfaction

    Measured: 2 years post-operative

  2. Wound complications - dehiscence

    Wound dehiscence

    Measured: 2 years post-operative

  3. 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.

  1. First posted18 Oct 2016 (estimated)
  2. Study startMar 2018 (estimated)
  3. Primary completionMar 2019 (estimated)
  4. Study completionMar 2020 (estimated)

Why it stopped: PI left the institution before any participants were enrolled.

Resources

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)
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

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.

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