Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06247761 |
| Other study ID # |
328761 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 29, 2024 |
| Est. completion date |
August 1, 2024 |
Study information
| Verified date |
January 2024 |
| Source |
Mid and South Essex NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
An RCT will be set up to compare outcomes between two groups of hand surgery patients. These
are:
• Emergency hand surgery patients - randomized to either absorbable or non-absorbable suture.
The primary outcomes investigated will be:
• Infection occurrence
The secondary outcomes will be:
- Scar appearance at 1 week and 6-8 weeks (assessed from photographs and scar scoring
scale)
- Wound inflammation as a percentage of wound length at day 7 post surgery.
- Patient symptoms at 1 week (assessed from patient questionnaire)
- Patient symptoms at 6-8 weeks (assessed from patient questionnaire)
- QDASH Score at 1 week (assessed from patient questionnaire)
- QDASH score at 6-8 weeks (assessed from patient questionnaire)
- Occurrence of other complications (assessed from the above photographs, the above
questionnaires and from nurse and doctor led reports of wound breakdown and other
complications)
Description:
SUMMARY OF TRIAL DESIGN
This is a single-center, single-blinded, RCT with a parallel-group design to compare two
groups of hand surgery patients.
TRIAL SETTING
The RCT will be a single- blinded single centre trial run at St. Andrew's Centre for Plastic
and Reconstructive Surgery, Broomfield Hospital (part of MSEFT). St. Andrew's Centre is one
of the busiest centres in the UK and plastic and reconstructive surgeons with many thousands
of hand surgeries taking place every year.
Recruitment and Invitation
The Patient information sheet (PIS) will be provided to the patients that meet the criteria.
If the patient declines, then it will be made clear that this will not affect their surgical
or wound care.
The patients will have 48 hours minimum to read the PIS and to discuss and ask questions from
our research team and the usual care team such as trauma clinic nurses, the research fellows,
and consultants.
All patients will be asked on the day of surgery if they are happy to participate in the
trial. If they agree to be in the trial, they will sign a consent form before the operation
on the pre-operative ward.
If patients have concerns or require more information about the study, there will be
provision for them to ask these questions in advance of the surgery day. The usual practice
is to ask patients if they have any questions after each consultation to avoid information
overload, unanswered questions, and anxiety. There will be no payments made to the
participants to take part in this trial.
Images
Imaging (photographs) of the wounds are an integral part of this study. This will include a
picture at 1 week post operation, and one picture 6-8 weeks post operation.
The images will be taken on a single digital camera. All photographs will be taken in the
same clinic room in the dressing clinic, with the same lighting for each of the patients.
All images will be transferred to a password protected NHS Desktop folder at the end of each
clinic day, and then deleted from the camera.
The images will then be saved on trust computers, in a trial specific password protected
folder under the participants study ID and visit number (i.e. STASSH TRAUMA xxx - week 1).
The anonymised images of the wounds/scars may form part of the presentations, thesis and
educational activities resulting from this project. A specific consent point has been
included in the ICF to cover this research activity.
Patients involved in the trial may have health conditions that impact the healing of their
wound, their scar appearance, and their symptoms.
The conditions known to impact wound healing are as follows:
- Diabetes
- Rheumatoid arthritis
- Ehlers-Danlos syndrome/connective tissue disorders
- Dermatological skin conditions effecting the hand e.g. eczema
- Patients on anticoagulant medication
- Patients taking immunosuppressant medication
All of the patient data will undergo stratification that will allow for a fair analysis to
take place, which accounts for the higher risk of wound complications. Multivariate
regression analysis will be undertaken in order to draw appropriate conclusions from the data
which is collected.
Randomisation
On the morning of day of surgery randomisation will be carried out by the trauma clinic
nurses/lead investigator. A simple sealed envelope randomisation process will be used.
There will be 480 envelopes in total. This ensures sufficient power for the study (400
minimum as per the reported 5% risk of infection from hand surgery), and takes into account
potential withdrawals and lost to follow-up of 80/480 patients i.e. 40/240 from each of the
two groups.
240 of these envelopes will be filled with a piece of paper marked with vicryl rapide suture,
and 240 will be filled with a piece of paper marked nylon suture.
Which envelope is filled with which suture material type will be decided by a random number
generator which will generate a number from 1-480, and each envelope will therefore be
sequentially filled.
The trauma clinic nurse will have a supply of 480 sealed envelopes marked 'STASSH TRAUMA -
randomisation number xxx' on the outside. These envelopes will be sequentially chosen in
order to randomise participants to either the absorbable or non-absorbable group. This
process will continue until 480 patients have been recruited into the study.
It is acknowledged that there may be some similarity between study ID and randomisation
number therefore additional care will be taken by the research teams to record this data
timely and accurately in the participants case report forms (CRFs).
For both groups, the patient will be blinded to the suture choice, and the operating team
will be provided with the suture according to the group that the patient has been randomised
to. As a result, the operating team will also be aware of the suture material being used.
The patient will be unblinded to suture allocation at day 7, when the non-absorbable group
patients will require stitch removal. They will be required to complete the first part of the
non-validated questionnaire, as well as the DASH questionnaire, BEFORE removal of their
dressing. This is to ensure their reported symptoms are not biased by the appearance of the
wound, or awareness of the suture type.
Blinding
Single blinding will be maintained by the patient's wound being covered with a dressing and
bandage for the first week post operatively.
All theatre and clinic staff will be aware of which group the patient has been randomised to
on the day of surgery. The sealed envelope will accompany the patient's notes into theatre
and identify the suture material to be used for skin closure.
The type of suture material used will not be revealed to the patient (either vocally or in
writing, before, during or after the surgery) but will be written in the operation note.
Data will be collected by staff in the dressing clinic, who are different to staff in the
trauma clinic/hand surgery theatres. This will occur at 7 days and 42-56 days post
operatively in dressing clinic and outpatient clinic respectively.
Patients will complete the first two questions in the non-validated questionnaire before
removal of dressings. They will complete questions 3 and 4 of the non-validated questionnaire
after removal of the dressing +/- stitch removal if indicated.
Patients will also be required to complete the DASH questionnaire before removal of the
dressing takes place. This is essential to ensure that symptoms reported are not influenced
by the patient or staff seeing the stitch material or appearance of the wound.
Unblinding
Although it is unlikely to be required over a short 7 day period, unblinding can be simply
done by review of the participants medical or theatre notes or by unbandaging the
participants hand where the choice of suture used would be obvious to clinical staff.
Any early unblinding will be recorded as a protocol deviation and would not be considered a
withdrawal unless the participant expressly voices their desire to withdraw from the study.
Data Collection
Data will be collected throughout the surgery and during follow up periods. Project data
collection will be managed by the research team and CI will oversee recruitment and
collection of data. The CI will be responsible for ensuring the accuracy, completeness,
legibility, and timeliness of the data reported.
A folder will be kept in the dressing clinic and outpatient clinic areas. All completed
patient questionnaires will be kept in this folder. The completed questionnaires will be
collected from the folder at the end of the day and kept securely and onsite.
All data will be in anonymised form; patients will be identifiable only by study number and
this will be sequentially allocated to patient at time of consent to participation on clinic
day.
Surgical Procedure
All patients will undergo a hand surgery procedure. For the trauma cohort this will include
tendon repairs, and open fractures. The only element of the surgery which will be affected by
this study will be the skin closure at the very end of the surgery before dressings are
applied. No study to date, has studied the effect of the structures impacted during hand
surgery, on the wound healing process.
As mentioned before, there have been studies on carpal tunnel release surgery, and whether
absorbable or non-absorbable sutures are superior. However there are significant limitations
to this. Carpal tunnel surgery does not involve any tendons, blood vessels, nerves or
ligaments. It is a 5-10 minute operation. Nobody to date has studied the effect of damaged
tendons, nerves, blood vessels and ligaments on the skin healing process, and in particular
if the choice of suture has an impact on wound healing in these cohorts.
The investigators are therefore adding first of its kind knowledge to the surgical
literature, and will genuinely be able to inform guidance for trauma hand surgery. Any
operating surgeon will be able to close the skin at the end of surgery, hence surgical acumen
and seniority of the surgeon are not felt to be a factor in this study.
Post- Operative follow up face to face - day 7 and day 42-56 and end of study
Patients will be seen in dressing clinic at day 7 for photos, and for both the QDASH and non
validated questionnaires to be filled. At day 7, the DASH questionnaire and the first part of
the non-validated questionnaire must be completed before the dressings are removed and the
patient is unblinded.
At day 42-56, the patient will be aware of the suture material already so any dressings can
be removed before any questionnaires are completed.
Once the patient has completed the questionnaires, and has pictures of the wound taken, this
defines the end of the study period for the patient.
STATISTICS
The power analysis for this study has been based on analysis by medical Statistician Dr Jufen
Zhang of Anglia Ruskin Medical School. The primary outcome measure is wound infection. The
sample size calculation is based on a 5% infection rate following hand surgery,
There are 480 (240 for each group) patients available in the study to compare differences
between 2 groups.
The baseline continuous data will be summarised by the mean (standard deviation) or the
median (25th - 75th percentile) depending on the distribution of data; categorical data by n
(%). The difference between the two groups will be examined based on an intention-to-treat
(ITT) principle.
The independent t-test or Mann-Whitey U test (depending on the distribution of the data) will
be conducted to test if there is a difference in primary outcome variable between the two
groups. The mean difference with 95% confidence intervals will be reported. A sensitivity
analysis will be conducted to assess the robustness of the primary analysis to missing data.
Logistic regression models will be used to identify determinants for wound inflammation,
complications, QDASH score and symptoms score. The study has more than 95% power to detect a
"medium" effect size of 0.25 (Cohen, 1969) using one-way ANOVA with a significant level of
5%. Stata statistical computer package will be used to analyse the data.
Our primary outcome measure is infection rates, with other outcome measures being; wound
inflammation as a proportion of wound length, scar appearance/score, QDASH score and patient
symptoms.
No study to date has studied inflammation as a proportion of wound length following hand
surgery. This is despite wound inflammation being an accurate predictor of pain from the
wound, as well as accurate predictor of developing an infection. As such, it is not possible
to perform a power calculation due to the paucity of the literature in this area.
For every patient, each of the outcomes the investigators are analysing will have a
differential impact on their overall satisfaction with the surgery and the wound itself.
For some patients, wound appearance will be paramount. For others, the function of their hand
(which the investigators will determine through the DASH and non validated questionnaires) is
the most important factor, and for some the symptoms from the wound will have the biggest
impact.
All of the primary and secondary outcome measures will be measured and analysed between the
two groups, and will be appropriately stratified with the patients past medical conditions,
use of post operative antibiotics, and the damaged structures in the surgery. Multivariate
regression will be performed to account for any potential confounders and ensure a reliable
analysis is performed.
This will ensure a fair comparison, and would be fairly and openly presented in any
subsequent presentations or publications. It would be incorrect, to weigh one of the outcome
measures more than the others, because every individual patient and surgeon values each of
the outcomes differently.
PLANNED RECRUITMENT RATE
The aim will be to recruit 25 patients a week in one site i.e. St. Andrew's Centre for
Plastic Surgery, MSEFT. This assumes a 20-30% recruitment rate (there are approximately 15
trauma operations occurring daily at MSEFT). Therefore, based on a sample size of 480 and 25
recruits per week, the recruitment period will be approximately 18-20 weeks.
WITHDRAWAL CRITERIA
The participant may withdraw their consent to continue in the study. If they withdraw their
consent prior to treatment no further research activity will take place.
If the participant withdraws after the operation no further research activity will be
undertaken and the participant will be followed-up according to standard care.
All data obtained prior to withdrawal will be retained as part of the study.
TRIAL MEDICATION
The sutures being used: polyglactin 910 (vicryl rapide), and ethilon (nylon), are already in
widespread use across the NHS for a wide variety of surgeries. They are approved by the
European Drug and Medicine authority.
Product Characteristics
VICRYL RAPIDE Suture, composed of 90% glycolide and 10% L-lactide copolymer, is a synthetic
absorbable suture intended to model the performance of collagen (surgical gut) suture with
less tissue reaction. It is indicated for use only in superficial soft tissue approximation
of the skin and mucosa, with wound support of 7-10 days.
Vicryl sutures are among the preferred sutures of clinicians due to the low antigenicity, and
sparse inflammatory infiltrates. Vicryl suture hypersensitivity is very rare. However, cases
of suture allergies have been reported as pruritus, oedema, pain, and seroma formation. At
the moment, no standardized method to test this reaction has been reported, and the rates of
these complications is not reported in the literature. Hence the investigators have pioneered
the measurement of inflammation as a proportion of wound length to measure this complication.
ETHILON Suture is a nonabsorbable, sterile surgical monofilament suture composed of the
long-chain aliphatic polymers Nylon 6 and Nylon 6,6. ETHILON Suture is dyed black or green to
enhance visibility in tissue. ETHILON Suture is indicated for use in general soft tissue
approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological
procedures. Only one incidence of adverse effects from nylon suture has rarely been reported
in the literature, with the patient having erythema and pain until sutures were removed.
Product storage and supply
All sutures are stored in theatre and are kept in sterile packets. They are stored at room
temperature.
They are simply opened onto a sterile trolley for the scrub nurse to load and give to the
operating surgeon when the time for skin closure comes.
Products will be taken from standard hospital stocks, and will not add to theatre costs.
