|- candidate number||14705|
|- NTR Number||NTR3946|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-apr-2013|
|- Secondary IDs||2011_093 METC|
|- Public Title||Staples versus Sutures.|
|- Scientific Title||Staples or Sutures for wound closure after Total Hip Arthroplasty.|
|- hypothesis||Sutures cause lower wound infections than staples.|
|- Healt Condition(s) or Problem(s) studied||Total Hip Arthroplasty, Wound closure|
|- Inclusion criteria||1. Adult patients;|
2. Elective total hip arthroplasty.
|- Exclusion criteria||1. History of ipsilateral hip surgery;|
2. Acute setting: Traumatic or pathological fracture;
3. Known skin diseases (e.g. allergies for suture or staple materials) or local skin deformities;
4. History of current or prior drug abuse or alcoholism, serious psychiatric and neurological illness;
5. Patients who are unable to give informed consent.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2012|
|- planned closingdate||1-apr-2016|
|- Target number of participants||1800|
|- Interventions||Closing the surgical wound made to perform a Total Hip Arthroplasty with either staples or sutures.|
|- Primary outcome||Wound infections (superficial and deep).|
|- Secondary outcome||1. Wound discharge;|
2. Wound dehiscence;
3. Wound necrosis;
4. Prolonged hospital stay (more than 5 days);
5. Time needed for wound closure in minutes;
6. Length of hospital stay in days after surgery;
7. Onset of complications (early = during admission / late = after discharged from hospital).
|- Timepoints||1. Day of discharge;|
2. 2 weeks (during removal of sutures/staples);
3. 6 weeks;
4. 3 months;
5. 1 year.
Wound infections, diagnosed as (according to definitions by CDC):
Occurs within 30 days after the operation AND infection involves only skin or subcutaneous tissue of the incision AND at least ONE of the following:
1. Purulent drainage, with or without laboratory confirmation, from the superficial incision;
2. Organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision;
3. At least one of the following signs or symptoms of infection: pain or tenderness, localized swelling, redness, or heat AND superficial incision is deliberately opened by surgeon, UNLESS incision is culture-negative;
4. Diagnosis of superficial incisional SSI is made by the surgeon or attending physician.
Occurs within 30 days after the operation if no implant is left in place or within one year if implant is in place and the infection appears to be related to the operation and infection involves deep soft tissue (e.g. fascia, muscle) of the incision and at least one of the following:
1. Purulent drainage from the deep incision but not from the organ/space component of the surgical site;
2. A deep incision spontaneously dehisces or is deliberately opened by a surgeon when the patient has at least one of the following signs or symptoms: fever (>38°C), localised pain or tenderness, unless incision is culture-negative;
3. An abscess or other evidence of infection involving the deep incision is found on direct examination, during reoperation, or by histopathologic or radiologic examination;
4. Diagnosis of deep incisional SSI made by a surgeon or attending physician.
Wound Dehiscence, diagnosed as:
Pathologic process consisting of a partial or complete disruption of the layers of a surgical wound without signs of SSI.
Necrosis, diagnosed as: A localized defect or excavation of the skin or underlying soft tissue that contains dead, avascular tissue. The level and type of tissue death influences the clinical appearance of the necrotic tissue. Examples of necrosis include white/gray non-viable tissue, stringy, yellow or tan slough and hard black eschar.
|- Trial web site||www.staplesorsutures.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD. W.H. Mallee|
|- CONTACT for SCIENTIFIC QUERIES||MD. W.H. Mallee|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam, Sint Lucas Andreas Ziekenhuis, Tergooiziekenhuizen, Amphia Hospital Breda|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC), Sint Lucas Andreas Ziekenhuis, Tergooiziekenhuizen, Amphia hospital|
|- Brief summary||Both staples or sutures are used for wound closure after Total Hip Arthroplasty (THA). Outcomes in terms of wound infection, inflammation, discharge, dehiscence and necrosis are comparable. Orthopaedic surgeons have to base their choice on underpowered studies with poor methodological quality. The main objective is to compare staples versus sutures for wound closure after Total Hip Arthroplasty.|
|- Main changes (audit trail)||11-May-2013: 10% of the inclusion has already occured at time of registration. The study protocol did not change during this time - NM|
|- RECORD||10-apr-2013 - 11-mei-2013|