The primary objective is to investigate which of the four suturing techniques (Monocryl Smooth Suture, Vicryl Rapide Suture in combination with Indermil Skin Glue, Dermabond Prineo Skin Closure System, Stryker Zip Skin Closure) shows the least…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is aberrant wound recovery after three days and
fourteen days postoperatively in patients after a THA.
Secondary outcome
Secondary outcomes are the occurrence of superficial- and deep wound infections
for the four suturing techniques during hospitalisation, fourteen days
postoperatively, and ninety days postoperatively, as well as the costs of each
of the suturing techniques, and whether, or not, patients have to visit the
outpatient clinic for a control appointment in standard care.
Background summary
With a mean age for a patient receiving THA being 69.4 years old, a precarious
situation is being brought to light. Wound recovery is impaired in elderly
patients, and poor wound recovery could result in the prosthesis not being
fully functional, which might lead to costly revision surgery. In order to
investigate which suturing method causes the least amount of wound recovery, we
would like to set up a scientific research trial which test the following
thesis; Hypothesis: Monocryl sutures give the highest amount of aberrant wound
recovery three days, and fourteen days after primary THA.
Study objective
The primary objective is to investigate which of the four suturing techniques
(Monocryl Smooth Suture, Vicryl Rapide Suture in combination with Indermil Skin
Glue, Dermabond Prineo Skin Closure System, Stryker Zip Skin Closure) shows the
least amount of aberrant wound recovery three days, and fourteen days
postoperatively in patients having undergone a THA.
The secondary objective is to investigate the occurrence of superficial- and
deep wound infections for the four suturing techniques during hospitalisation,
fourteen days postoperatively, and ninety days postoperatively, as well as the
costs of each of the suturing techniques, and whether, or not, patients have to
visit the outpatient clinic for a control appointment in standard care.
Study design
Prospective, randomised trial.
Intervention
In this study, four methods of wound closure will be compared to each other.
These methods are:
- Monocryl Smooth Suture
- Vicryl Rapide Suture in combination with Indermil Skin Glue
- Dermabond Prineo Skin Closure System
- Stryker Zip Skin Closure
Study burden and risks
The burden of participation will consist of completing questionnaires fourteen
days postoperatively, and ninety days postoperatively. This will be done during
the outpatient clinic visits that all patients participating in this study will
make fourteen days after undergoing primary THA. Too, participating patients
will face the additional burden of having a photograph of their wound taken
during their outpatient clinic visit. Some patients may not be too fond of
this, so this could provide additional mental stress. Furthermore, patients
will be confronted with the uncertainty surrounding the randomisation process.
Not knowing exactly which suturing technique is going to be used could result
in mental stress. An additional risk associated with the participation in this
study is the possibility that one or more suturing techniques underperform when
compared to the others. There is no direct benefit for the subjects.
Toneellaan 2
Zoetermeer 2725 NA
NL
Toneellaan 2
Zoetermeer 2725 NA
NL
Listed location countries
Age
Inclusion criteria
• >= Eighteen years old
• Scheduled to undergo a primary THA via the anterior approach by one of the
participating surgeons, for any indication
• No prior operations of the hip which is to be operated on for this study
• Able to provide written informed consent
• Patient is able to speak and write in Dutch
Exclusion criteria
• Use of cytostatic substances in the period ranging from fourteen days prior,
to ninety days after the surgery.
• Difficulty with or inability to communicate with the investigators (e.g.
difficulty with the Dutch language, cognitive /memory disorder).
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL85803.058.24 |