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International Orthopaedics (SICOT)

DOI 10.1007/s00264-015-2726-6

ORIGINAL PAPER

Randomized controlled trial of conventional versus modern


surgical dressings following primary total hip and knee
replacement
Jean Langlois & Amine Zaoui & Camille Ozil &
Jean-Pierre Courpied & Philippe Anract &
Moussa Hamadouche

Received: 11 February 2015 / Accepted: 25 February 2015


# SICOT aisbl 2015

Abstract Introduction
Purpose We prospectively compared two types of dressing
(conventional gauze-based versus absorbing hydrofibre) after The increasing numbers of lower limb arthroplasties, com-
primary total hip (THA) or knee (TKA) arthroplasties. bined with a considerable pressure on healthcare providers
Methods Eighty candidates for THA (n=40) or TKA (s=40) to increase patients’ satisfaction and minimize overall costs,
were randomized: gauze-based versus hydrofibre absorbing have instigated new clinical pathways and multidisciplinary
(Aquacel®, ConvaTec). The two groups were comparable at protocols [1, 2]. Promoting optimal wound healing and
baseline. preventing surgical site infection is one of the cornerstones
Results There was a statistically significant decrease of dress- of these regimens. Wound healing involves both local and
ing changes in the hydrofibre group (p=0.0006). Two patients systemic host factors [3], surgical considerations [4], but also
from the conventional group presented minor wound compli- relies on the dressing that is applied. An ideal environment
cations. Nurses’ satisfaction was significantly higher in the promoting healing should be moist, warm and clean [5].
hydrofibre group considering the adherence (p=0.04) and Therefore, a perfect dressing should absorb sufficient exudate,
flexibility (p=0.03). Patients experienced a higher satisfaction while being permeable enough to control a moist environ-
with respect to ease of movement (p=0.01) in the hydrofibre ment. In addition, a dressing must act as a watertight barrier
group. The cosmetic appearance of the scars six weeks after against the external environment, while also allowing the
surgery was found to be similar between groups. wound to breathe [6].
Conclusions Our findings support an overall improved com- Aside from questions related to the moisture-permeability
fort for the patients and the medical staff by using hydrofibre balance, total joint arthroplasty wounds present morphologic
dressings after primary THA and TKA. The reduction of re- specificities [7]. Dressings over joints should accommodate
quired dressing changes was observed also. motion allowing wide and free range of movements with no
risk of friction. Moreover, following joint replacement, the
Keywords Wound dressing . Hip arthroplasty . Knee skin is often frail and subject to postoperative oedema fluctua-
arthroplasty . Patient satisfaction . Nurse satisfaction tions. Consequently an ideal dressing devoted to the
arthroplasty field should allow wound inspection. If not trans-
J. Langlois (*) : A. Zaoui : J.<P. Courpied : P. Anract : parent, this innovative dressing should therefore come with
M. Hamadouche sufficient warranties to allow a safe reduction of the number
Department of Orthopaedic and Trauma Surgery, Hôpital Cochin,
of changes [7]. In addition, changing dressings remains often a
Université Paris-Descartes, Assistance Publique-Hôpitaux de Paris,
27 Rue du Faubourg St Jacques, 75014 Paris, France painful procedure [8], which is time- and cost-consuming, and
e-mail: jeangast@gmail.com still represents a contamination risk.
The hydrofibre (Aquacel®, ConvaTec, Greensboro, NC,
C. Ozil
USA) dressing is a highly absorbent sterile hydrocolloid
Department of Reconstructive Surgery, Hôpital Européen Georges
Pompidou, Université Paris-Descartes, Assistance (carboxymethylcellulose) wound dressing that converts into
Publique-Hôpitaux de Paris, 20 Rue Leblanc, 75015 Paris, France soft gel when it comes in contact with wound exudates. Its
International Orthopaedics (SICOT)

main advantage is based on the concept that the dressing can Procedures
be left without regular changes, while providing a micro-
environment that is supposed to facilitate healing. Based on All surgical procedures were carried out by three experi-
all these considerations, we conducted a randomized con- enced lower limb reconstruction surgeons. Total hip re-
trolled trial (RCT) to compare the modalities of use and the placements were performed using either an anterior ap-
effect of postoperative surgical dressings (conventional versus proach in supine position as modified by Röttinger [9], or
hydrofibre) on patients and nurses’ satisfaction in two pro- a transtrochanteric approach, with the patient in lateral po-
spective randomized series of primary total hip or knee sition. Total knee replacements were performed through a
arthroplasty. We hypothesized that the use of hydrofibre dress- standard medial parapatellar approach. A tourniquet was
ings would reduce the number of dressing changes during used according to the surgeons’ usual practice (unless there
hospital stay. was contra-indication related to peripheral arterial disease),
whereby two of the surgeons always used tourniquet and
one did not use it. Surgical closure was standardized in-
volving three layers. The deep layer was repaired using a
Materials and methods resorbable number 0 Vicryl® (Ethicon, Johnson & Johnson,
Norderstedt, Germany). A subdermal layer was closed with
Study design a 2–0 Vicryl®, followed by simple interrupted stitches for
skin closure with 3–0 monofilament nylon. The suction
A power analysis, based on the expected difference of num- drain exits were carefully positioned away from the wound,
ber of dressing changes, was performed. The number of so their removal would not disturb wound dressing. In the
patients to include was calculated assuming that a mean hydrofibre group, an Aquacel® dressing pad was placed in
number of two (SD 1) dressing changes during hospital stay intimate contact with the wound. It was not covered by any
would be necessary in the conventional dressing group ver- extra dressing in order to facilitate direct inspection. In the
sus one in the hydrofibre dressing group. With a two-sided conventional group, sterile gauzes were spread over the
risk alpha of 2.5 % and a power (1 - beta) of 90 %, calcu- wound and held in place with a crepe bandage. Wound
lation indicated that 25 patients would be needed in each dressings applied intra-operatively were secondarily
group. After adjustment for non-compliance/cross-over, we changed under a specific protocol for each group. In the
decided to include 40 patients in each arm. The patients conventional dressing group, the dressing change was
were randomized using a computer-generated block ran- scheduled between day one and day three postoperatively,
domization scheme to have either conventional or associated to a second change on the day of discharge.
hydrofibre dressing. The randomization was based on the Gauzes were then replaced by a conventional adhesive
order of patient presentation, so each patient was random- pad (Mepore, Mölnlycke Health Care, Göteborg, Sweden).
ized individually regardless of severity of osteoarthritis and In the hydrofibre absorbing group, the change was only
co-morbid situation. To avoid surgeon bias, randomization scheduled the day of discharge. In both groups, an extra
was stratified by surgeon. They all had given informed con- change of dressing was performed in case of saturation with
sent, and the study was IRB approved. leakage, major loss of adherence, bleeding, or suspected in-
fection. The post-operative regimen included the administra-
tion of systemic antibiotics for 48 hours, thromboprophylaxis
Patients with low molecular weight heparin (enoxaparin 40 SC/day)
for six weeks, and anti-inflammatory medication (ketoprofen,
This RCT was conducted over a six-month period in a sin- 100 mg/day for five days) to prevent heterotopic ossification
gle institution. Eighty consecutive patients with unilateral in the THA group. Immediately after the operation, passive
primary degenerative osteoarthritis of the hip (n =40) or exercises were begun with the assistance of a physiotherapist,
knee (n=40) requiring total joint replacement were enrolled and were continued until active movement of the hip was
in the study. The inclusion criteria were patients aged be- possible. The patients were free to walk after three days with
tween 18 and 95 years and able to understand information. crutches. Patients were usually discharged five to seven days
The exclusion criteria were prior operative local procedure postoperatively.
around the joint, past local infection, and advanced cancer.
Demographic characteristics including age, gender, body Outcomes
mass index (BMI), smoking status, medical comorbidities
(diabetes mellitus, renal insufficiency and skin or vascular The primary outcome was the effective number of dressing
disorders), in addition to medications (steroids) were changes during the hospitalization. Several secondary out-
recorded. comes were recorded: (1) wound complications, including
International Orthopaedics (SICOT)

erythema, blistering, delayed healing, maceration, scarring, Results


necrosis and infection, (2) patients and nurses satisfactions,
and (3) scar cosmetic appearance evaluated six weeks after Of the 80 included patients, a total of 75 satisfaction evaluation
surgery by a plastic surgeon that was blinded to the dressing forms (93.8 %) were obtained and 73 wound scars (91.3 %) were
used and not involved in the surgical procedures. Satisfaction evaluated with no patient lost to follow-up (Fig. 1). There was no
was recorded the day of discharge using self-administered significant difference between the conventional and hydrofibre
questionnaires. For patients, parameters evaluated included groups in terms of demographics (Table 1). The mean number
pain during dressing change, anxiety, pain outside change, of dressing changes in the conventional group was two (ranges,
ease of movement, itching/stinging/burning/odour, and over- two to five) versus one (ranges, one to four) in the hydrofibre
all satisfaction. For nurses, parameters were ease of use, pa- group (p=0.0006) (Table 2). Two patients from the conventional
tient apprehension, patient pain, adherence, bleeding, dressing group underwent a minor wound complication (blistering
conformability, and overall satisfaction. Likert scale discrete in one case, erythema without proven infection in the other case),
[10] answers were assigned numbers for the analysis (0: high- that did not require any additional surgical procedure nor antibiotic
ly unsatisfied; 1: not satisfied; 2: fairly satisfied; 3: satisfied; 4: therapy. No allergic-like reaction was recorded in the hydrofiber
highly satisfied). Wound cosmetic aspect was evaluated using group. Nurses’ satisfaction was significantly higher in the
three different validated scales: Stony Brook [11], visual ana- hydrofibre group considering the adherence (p=0.04) and the
log cosmetic [12], and categorical (poor, acceptable or excel- flexibility (p=0.03) categories. Patients in the hydrofibre group
lent categories). experienced a higher satisfaction considering their ease for move-
ment (p=0.01). Other criteria (apprehension, pain, bleeding during
Statistical analysis change, odour or itching) were not found to be significantly dif-
ferent between groups with the numbers available (Table 2). Six
Statistical analyses were performed with Real Statistics Re- weeks after surgery, the overall wound scar aspect was found to be
source Pack software, version 2.10 (Miller Place, NY, USA). similar between groups, according to the three scales (Table 2).
Normal distribution was tested by the Shapiro–Wilk test. If the
distribution was normal, the parametric Student’s t-test was
used for quantitative variables and chi-squared test for quali- Discussion
tative data. Otherwise, nonparametric Mann–Whitney test and
Fischer’s exact tests were used. A p value of less than 0.05 was Aside from the question of suction drainage [13], the identifi-
considered to be significant. cation of an optimal dressing for total joint arthroplasty

Assessed for eligibility (n=85)

Excluded (n=5)
- Not meeting inclusion criteria (n=5)
- Declined to participate (n=0)

Enrolled (n=80)

THA (n=40) TKA (n=40)

20 patients randomized 20 patients randomized 20 patients randomized 20 patients randomized


to Hydrofiber to Conventional to Hydrofiber to Conventional

6 weeks follow-up 6 weeks follow-up 6 weeks follow-up 6 weeks follow-up

- Lost to F/U (n=0) - Lost to F/U (n=0) - Lost to F/U (n=0) - Lost to F/U (n=0)
- Questionnaire (n=19) - Questionnaire (n=18) - Questionnaire (n=19) - Questionnaire (n=19)
- Scar evaluation - Scar evaluation - Scar evaluation - Scar evaluation

Fig. 1 Study protocol


International Orthopaedics (SICOT)

Table 1 Demographic characteristics of the 80 included patients dressing are numerous: (1) an optimal moist balance for
Dressing Conventional Hydrofiber p-value healing, sequestering fluids to avoid maceration while releas-
(n=40) (n=40) ing a gel that maintains a humid environment, (2) its imper-
meable nature also strongly impacts the interval between
Age (year) a 68.3±10.3 71.1±11.4 0.34 dressing changes: despite being highly dependent on the
Sex ratio (female/male) b 29 F / 11 M 27 F / 13 M 0.63 amount of exudate produced by the wound, a hydrofibre
BMI (kg/m²) a 26.8±4.4 25.4±4.3 0.22 dressing may frequently be of help in place up to seven days.
Diabetes mellitus b 6 2 0.26 In the current RCT following total joint arthroplasty proce-
Steroid dependance b 4 6 0.74 dures, the use of hydrofibre dressings significantly decreased
Severe renal insufficiency b 0 0 1 the number of dressing changes, and leads to higher levels of
Smoking b 2 7 0.15 satisfaction from both the nurses’ and patients’ perspectives,
Skin or vascular disorder b 1 1 1 considering respectively adherence and flexibility in one side,
and ease of movement on the other side. We did not show any
Data are expressed as means ± standard deviations, or absolute number of
cases (n) statistical difference in terms of peri-wound injury or short-
M male, F female, BMI body mass index
term cosmetic appearance of scars.
a
Student’s t-test b Two-tailed Fisher’s exact test
Our study has several limitations. We recognized having
controlled most but not every wound healing confounding
wounds is an area sometimes neglected by orthopaedic sur- factor, such as protein or vitamin C deficiencies, liver or thy-
geons, although wound complications can lead to serious con- roid diseases [14]. Our protocol did not register the compara-
ditions. In this context, potentials advantages of the hydrofibre tive time to complete wound healing, and was not powered
enough to compare wound complications, as the natural oc-
currence of such adverse events is very low. We also acknowl-
Table 2 Comparative dressing performance edge that the potential care improvement related to the dress-
ing would not be sufficient by itself to demonstrate a major
Dressing Conventional Hydrofiber p-value
clinical difference with a reasonable inclusion number of pa-
Number of dressing changes a 2±0.94 1±0.91 0.0006 tients in only one centre. Further trials will be needed to eval-
Peri-wound adverse reaction b 2 0 0.49 uate the potential benefits from these hydrofibre dressings
Nurses satisfaction c both in terms of prevention of wound infections or reduction
Ease of use a 3±0.59 4±0.49 0.13
of length of stay.
Patient apprehension a 3±0.73 4±0.59 0.38
Published data regarding the clinical performance of
Patient pain a 4±0.69 4±0.66 0.44
hydrofibre dressings are still limited and conflicting. The Na-
tional Institute for Health and Clinical Excellence (NICE)
Adherence a 3±1.09 4±0.89 0.04
guidelines suggest that no clinical evidence exists to support
Bleeding a 4±1.07 4±0.56 0.21
one dressing over another [15]. This opinion has been sup-
Conformability a 3±0.71 4±0.49 0.03
ported recently by Collins et al. [4] in a recent exhaustive
Overall experience a 3±0.64 4±0.67 0.26
review. In addition, Ubbink et al. [16] demonstrated that the
Patients satisfaction c
new occlusive dressings provided no advantage in terms of
Pain during change a 4±0.60 4±0.48 0.54
wound healing. On the other side, another body of the litera-
Anxiety a 4±0.75 4±0.75 0.65
ture indicates that these modern absorbing dressings might be
Pain outside change a 3±0.90 3±0.97 0.20
associated with shorter wear time, less changes required, and
Ease of movement a 3±0.81 4±0.85 0.02
less blistering [17–19], together with reduced surgical site
Itching/stinging/burning/odour a 4±1.05 4±0.80 0.62
infection [14]. However these studies were of low level of
Overall experience a 3±0.51 3±0.80 0.97
evidence, being either retrospective, or non-randomized.
Cosmesis six weeks postop
Moreover, patients’ and nurses’ satisfactions were not taken
Stony Brook scale a 0±1.62 1±1.71 0.55
into account, neither was the cosmetic appearance of the scar.
Visual analog cosmetic scale a 50±19.3 47.5±15.4 0.53
In the absence of solid scientific proof, the selection of
Categorical scale a 0±0.71 0.5±0.63 0.66 postoperative dressing should in fact be based on a compro-
Data are expressed as median ± standard deviations mise between evidence-based and patient-focused consider-
a
Mann–Whitney test ations. Satisfaction questionnaires evaluating patient comfort
b
Fisher exact test
are indeed of major importance [20]. Studies incorporating
c
Likert scale discrete answers were assigned numbers for the analysis (0:
specifically such outcomes are yet scarce [21, 22]. In the as-
highly unsatisfied; 1: not satisfied; 2: fairly satisfied; 3: satisfied; 4: highly sessment of a dressing an additional difficulty may be attrib-
satisfied) uted to patients’ difficulty to differentiate postoperative
International Orthopaedics (SICOT)

wound pain from discomfort dressing-related. In addition, quality of life, excess length of stay, and extra cost. Infect Control
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