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Eur J Cardiothorac Surg 2002;22:271-277
© 2002 Elsevier Science NL

Sternal wound closure in patients undergoing open-heart surgery: a prospective randomized study comparing intracutaneous and zipper techniques

Ivar Risnes*, Michel Abdelnoor, Runar Lundblad, Svein Tore Baksaas, Jan L. Svennevig

Department of Thoracic and Cardiovascular Surgery, Rikshospitalet, N-0027 Oslo, Norway

Received 16 January 2002; received in revised form 19 April 2002; accepted 22 April 2002.

* Corresponding author
e-mail: ivar.risnes{at}rikshospitalet.no


   Abstract
Top
 Abstract
1. Introduction
 2. Methods
 3. Results
 4. Discussion
 References
 
Objective: A prospective, randomized study was undertaken to compare a non-invasive surgical zipper to intracutaneous suture closure in open-heart surgery with respect to postoperative wound infection rate and cosmetic results. Methods: A total number of 300 patients were included in the study, of which 150 had their skin wound closed with zipper and 150 with intracutaneous suture. The end-points were superficial and deep sternal wound infections within 6 weeks postoperatively. Results: The incidence of total infection after 6 weeks was equal in the two groups (6.7 vs. 6.7%) (P=0.94). The superficial infection rate was 5.3% in the zipper group vs. 6.0% in the intracutaneous, and the deep infection rate was 1.4% in the zipper group and 0.7% in the intracutaneous. There was no statistically significant difference between the groups. Only the cosmetic result differed. On a visual scale from 1 (poorest) to 10 (best), an average score of 8.2 was obtained in the intracutaneous group versus 8.9 in the zipper group (P<0.01). Conclusion: The wound infection rate was equal for the intracutaneous group compared with the zipper group; however, the cosmetic result was judged better by the patients in the zipper group.

Key Words: Sternal wound infection • Wound closure • Surgical zipper


   1. Introduction
Top
 Abstract
 1. Introduction
2. Methods
 3. Results
 4. Discussion
 References
 
The Medizip Surgical Zipper represents a new non-invasive method of surgical wound closure. Until now intracutaneous suture has been the traditional method of sternal wound closure in our department [1].

The etiology of sternal infections following cardiac surgery is multifactorial, and implicates many risk factors [1–5]. Most pathogens, whether endogenously or exogenously acquired, are believed to be implanted at the time of surgery [6,7]. A recent study from our department comparing intracutaneous versus transcutaneous suture technique indicates that the wound closure technique may represent an important risk factor for postoperative sternal infection after cardiac surgery [1]. The incidence of superficial wound infection was significantly increased with the intracutaneous technique compared with the percutaneous method. The cosmetic result was equal for the two techniques.

Traditional suture closure may create tension across the width of the wound contributing to inadequate circulation [8,9]. Moreover, bacterial adhesion to surgical sutures represents an important factor in the development of postoperative wound infection [10,11].

The goal of wound healing is to prevent wound infection, and to achieve a good cosmetic result. The non-invasive surgical zipper closure may contribute to the natural healing process of the wound by a homogeneous distribution of tension across the entire wound area. In this prospective randomized study we wanted to investigate the advantages and disadvantages of the Medizip Surgical Zipper versus intracutaneous skin closure in patients undergoing open-heart surgery.


   2. Methods
Top
 Abstract
 1. Introduction
 2. Methods
3. Results
 4. Discussion
 References
 
2.1. Patients and procedures
Rikshospitalet is a university hospital that receives mainly high-risk patients, and patients undergoing complex procedures. Between June 2000 and July 2001, a total of 300 patients undergoing open-heart surgery were included in this prospective, randomized study. There were 96 women and 204 men with mean age 64.6 years (range 24.0–85.5 years). Ninety-four patients underwent coronary artery bypass grafting, 66 patients valve replacement or plasty, 58 patients had combined coronary artery bypass grafting and valve replacement, while 82 patients underwent various other procedures, including surgery of the thoracic aorta.

Patients undergoing elective or emergency cardiac surgery with sternotomy and cardio-pulmonary bypass (CPB) were included in the study. The only exclusion criteria were immunosuppressive or steroid medications prior to surgery.

All patients who developed mediastinitis underwent re-exploration with debridement, sternal closure ad modem Robicsek [12], and mediastinal irrigation with antibiotic solution and systemic antibiotic therapy.

The study was approved by the regional ethics committee.

2.2. Surgical technique
Anaesthesia was induced with diazepam, fentanyl and pancuronium and maintained with fentanyl, midazolam, isoflurane (Alpharma, Oslo, Norway) and nitrous oxide.

In all patients the operative approach was through a median sternotomy, with cardio-pulmonary bypass and moderate systemic hypothermia. Thirty-two patients were operated in deep hypothermia and circulatory arrest. Cold crystalloid cardioplegia and topical cooling with ice slush were used routinely. All CPB circuits were heparin-coated with Baxter Duraflo II, including the Spiral Gold Oxygenator, (Baxter Health-Care Inc., Irvine, CA). The initial heparin dose was 4 mg/kg to achieve an ACT>480 s. After CBP was terminated, protamine sulfate 10 mg/ml (Leo, Løvens Kemiske Fabrik, Copenhagen, Denmark) was administered to re-establish preoperative ACT level. Mediastinal shed blood was retransfused. The amount of heparin and protamine, the ACT values, the mediastinal blood loss, and the retransfused blood volumes during the first 12 postoperative hours were recorded in all patients.

2.3. Data collection and analysis
Data were obtained from our surgical database, and by review of the patients‘ charts, including the following preoperative risk factors: age, gender, underlying disease, preoperative functional class (New York Heart Association (NYHA) classification), cardiac index, chronic obstructive pulmonary disease, redo surgery, preoperative serum creatinine, endocarditis, emergency surgery and previous myocardial infarction (Table 1). Operative risk factors included operative procedure, duration of anaesthesia and CPB, aortic cross-clamp time and emergency vs. elective surgery. Postoperative factors included duration of mechanical ventilation, number of blood transfusions, re-exploration for bleeding, mediastinal drainage and length of hospital stay.


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  		Table 1. Analysis of potential risk factors for total infectiona

 
2.4. Wound closure methods
The patients were randomly selected for skin closure with poliglecaprone (Monocryl 3-0, Ethicon, Johnson and Johnson) intracutaneous suture (IC group; n=150) or Medizip Surgical Zipper (ATRAX, Medical Group, Bermuda) (MZ group; n=150). In both groups the sternum was closed with steel wires and the subcutaneous layer with polyglactin (Vicryl 2-0, Ethicon). Poliglecaprone is a resorbable monofilament suture and polyglactin is a resorbable multifilament suture.

Medizip is a combination of hypoallergenic, microporous polyester, coated with acrylate adhesive and a zipper, and is economically not more than 50% higher, and needs no bandage, compared with ordinary intracutaneous suture (Fig. 1) . The economical considerations will probably not prohibit the appliance of the zipper in routine cardiac surgery. The skin was cleaned with alcohol, and the wound elongated manually to approximate the wound edges. The zipper was routinely not opened until removal after 12 days.



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  		Fig. 1. Medizip surgical zipper showing the method of puncture-free skin closure.

 
The patients admitted were included in a prospective block randomized clinical trial. The randomization was done according to the principle of the envelope method with blocks of 40 patients (20 to intracutaneous and 20 to zipper closure). They received standard antibiotic prophylaxis with three times 2 g cephalotin i.v. during 24 h, eventually continued until all drains or monitor lines were removed.

The sternal wound was inspected after 6 weeks by the patients themselves. All patients were informed about the study and the infection signs, and all wanted to take part. Assessment of wound infection was made according to the specific classification scheme as previously suggested by Andenaes et al. [13–15]. Each wound was given a score from 0 to 7 with zero representing the optimal, physiologic postoperative wound appearance. The superficial wound infection (SWI) was defined as a score of 4 or more, that means postoperative wound conditions with pus combined with other signs or symptoms [13–15]. Deep wound infection (DWI) included acute mediastinitis with sternal dehiscence and osteomyelitis of the sternum. The patients themselves graded the wound, and defined if infection had appeared or not. At the same time they cosmetically evaluated the wounds, using a visual scale from 1 to 10, with 10 representing the best.

2.5. Baseline blood samples
Haemoglobin, leukocytes, C-reactive protein and S-creatinine were determined preoperatively, and on the 1st, 2nd and 3rd day postoperatively.

2.6. Statistical methods
We estimated the crude effect of the two techniques of wound closure on different endpoints by odds ratio and 95% confidence interval using the Mann–Whitney U-test and Fisher's exact test.

The major endpoints were the total number of infected patients (SWI and DWI), SWI and DWI.

To adjust for possible risk factors, we used the multivariate logistic model to estimate the efficacy of the two treatments when controlling for the major risk factor [16,17].

The univariate analysis was performed using Epi-6 [18], and the multivariate analysis with BMDP [19].


   3. Results
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
4. Discussion
 References
 
3.1. Clinical observations
The two groups of patients were comparable with respect to intraoperative and postoperative variables. Of the preoperative variables there was a significant difference in age and chronic obstructive pulmonary disease between the groups. In the IC group the age was 63.1 years versus 66.3 years in the MZ group (P=0.05). Chronic obstructive pulmonary disease was found in seven patients in the IC group versus 19 patients in the MZ group (P=0.02). Nineteen patients died within 30 days of surgery (7.3%); early mortality was 6.9 and 7.8%, respectively, for the IC versus the MZ group (P=0.12).

One patient developed mediastinitis on the second postoperative day. In the other patients signs of clinical infection presented later than the third postoperative day, and none of the zippers were opened during the hospital stay. The incidence of total infection after 6 weeks was equal in the two groups (6.7 vs. 6.7%), which gives an odds ratio of 1.0 (95% confidence interval (CI) 0.37–2.69) (P=1.0). The risk of superficial wound infection in the MZ group was 5.3 vs. 6.0 in the IC group, which gives an odds ratio of 0.88 (95% CI 0.30–2.58) (P=0.80). The incidence of mediastinitis in the IC group was 0.7% compared with 1.4% in the MZ group, odds ratio 2.01 (95% CI 0.14–5.60) (P=0.56) (Table 2).


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  		Table 2. Crude effect of IC vs. MZ on the end-points SWI, DWI and total infectiona

 
3.2. Risk factors
We studied a series of potential risk factor of the three endpoints. In order to adjust for the effect on the end point SWI, we used a multivariate logistic model and we adjusted for the multiconfounder age/aortic cross-clamp time. This gives an odds ratio of 1.04, 95% CI 0.37–2.85, and no reduction for the risk of developing SWI in patients with MZ group as compared with IC suture (P=0.94) (Table 3). For total infection we adjusted for the same multiconfounders, The adjusted odds ratio was 1.51, 95% CI 0.45–2.93, indicating no difference in infection incidence (P=0.76).


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  		Table 3. Adjusted effect of MZ/IC on the end points of total infection and SWI using the multivariate logistic modela

 
3.3. Baseline blood samples
There were no differences between the groups for any of the haematological parameters (Hb, leucocytes, CRP and S-creatinine).

3.4. Microorganisms
Among the 20 infected patients the causative organism was Gram-positive bacteria Staphylococcus aureus which was found in 50% of the patients. In one patient, Candida albicans was found, while in four patients there was no growth. In another five infected patients no bacterial tests were performed.

3.5. Cosmetic results
The patients were satisfied with the cosmetic results. On a cosmetic scale from 1 to 10, an average score of 8.2 (±1.6 SD) was obtained in the IC group versus 8.9 (±1.5) in the MZ group (P<0.01).


   4. Discussion
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
References
 
In this prospective study, 20 of 300 patients (6.7%) developed sternal wound infection after open-heart surgery. This incidence is accordance with some previous reports [2–5]. Seventeen patients developed SWI (5.7%) and three, DWI (1.0%). The surgical wound healing process takes as long as six to eight weeks, and may be altered by a variety of factors. There is little information in the literature regarding the frequency of superficial infection in open-heart surgery. In a previous study comparing intracutaneous and transcutaneous suture techniques we found that the wound closure technique may represent an important risk factor of postoperative sternal wound infection after cardiac surgery. The incidence of superficial wound infection was significantly increased with the intracutaneous technique compared with the percutaneous method. However, the cosmetic result was equal for the two techniques [1].

In the present trial the infection rate was equal for the intracutaneous group compared with the MZ group, based on the patients own assessment. However, the cosmetic result of the scars was significantly better for the zipper. As most patients are transferred to their local hospitals on the third postoperative day, and the clinical signs of infection occur after day 3, we assume that the problem of sternal wound infection may often be underestimated. Andenaes has previously demonstrated that the patient's assessment of the wound is as good as the doctor's assessment [15]. The patients were told that the zipper method represents a new method to be tested. The possibility for placebo effect is present as the patient may expect the zipper to leave a better cosmetic result and less infection. However, this method excludes the possibility of bias by the blinded investigators. An assessment by a third party was not possible for practical reasons, as all patients referred to Rikshospitalet come from the entire country. In order to include a high number of patients, asking the patient to fill in a standardized questionnaire covered routine control assessment of the wound.

Prior to this study we estimated the total incidence of infection in our patient group to be around 11%. After moving to a new hospital building in June 2000, the average incidence of infections dropped from 11 to 6.7%. This drop created a certain power deficiency in our study.

Mechanical forces acting across the width of wounds may contribute to the formation of scars that are functionally or cosmetically unsatisfactory [7]. Tissue trauma also represents a certain risk of wound infection that can be further increased by the various application techniques using sutures and staples [8,9]. Bacterial adhesion to foreign suture material may represent a factor in the development of postoperative wound infection [20].

When tissue is injured, a typical sequential vascular response to injury occurs. After the initial vasodilatation, the damaged vessels may occlude to thrombosis, and the larger muscular vessels contract. An inadequate circulation limits the healing [7,20,21].

The present study compared a non-invasive surgical zipper to intracutaneous suture skin closure. Poliglecaprone intracutaneous suture was applied superficially in the dermis. This might promote the access of superficial bacteria into the underlying suture and tissue, where adhesions, interfilament spread and protection from phagocytosis might provide an easier development of infection. The overall limit of oxygen present in a healing wound is very important for postoperative wound infection, as decomposition of absorbable sutures necessarily needs oxygen additionally to the requirements for healing process. The relation between ischaemic tissue after surgery, protection from phagocytosis and easier survival of bacteria are of critical importance to wound healing and to the susceptibility of infection [7,20,21]. The most important requirements for good scar result are primary wound healing without tension and lack of trauma to the wound edges [22,23]. The Medizip Surgical Zipper provides a homogeneous distribution of stress (tensile forces and shearing forces) across the entire wound region, and causes less oedema than the intracutaneous sutures [23,24]. The patient's own skin is considered to represent the main source of pathogenic bacteria. The main routes of entry of these organisms are via the surgical incision at the time of operation and sutures for wound closure [6,20].

In our study Monocryl 3-0 IC was used intracutaneously. Bacterial adhesion to surgical sutures is an important factor in the development of postoperative wound infection. Low virulent bacteria, e.g. Staphylococcus epidermidis, are highly adhesive to biomaterials in general [20].

With Medizip, the risk of invasion from skin pathogens is considered to be reduced. Many of these objectives are overcome because there is no perforation of potentially infected structures in the skin, no foreign body reaction to facilitate bacterial invasion and no tension in the wound area [20–25].

Considerations when choosing an appropriate suture for wound closure and healing should include strength of suture, holding power of tissue, bacterial adherence to surgical sutures and risk of infection. Based on these methods the zipper closing system was expected to be a safe alternative to conventional suture material. Wound edge approximation is even and enables an undisturbed healing progress. The surgical demands of a wound free of tension are met to a considerable extent by the lack of trauma to the wound edges [25]. However, introduction of a new material and a new procedure may be associated with initial handling problems.

The edges of the wound have to approximate without leaving any gaps or overlapping. This is not always the case, and may represent a certain risk of wound infection and varying cosmetic results. In a few patients the zipper was opened, and wound inspection was done. We saw a small step formation at the edges in the wound area in many patients, and a dead space of blood collection between the zipper and the skin. The zipper is a non-invasive closing system, but may potentate wound infection when necrotic or devascularized tissue, haematoma or dead space caused by tissue damage or poor surgical technique are present. When applying the Medizip it is important that a distance of 0.5 cm is maintained between the zipper teeth and the edge of the wound, and that there is an adequate subcutaneous suturing with good haemostasis.

Opening the zipper is noticeably difficult, and may disturb the wound-healing progress. The adhesive strength of the zipper is good. Once glued to the skin in the operation room it remains securely in place, and removing too early can disturb wound healing. Skin reactions or allergic reactions were observed neither by the staff nor the patients (see Fig. 2) .



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  		Fig. 2. A typical patient the 10th postoperative day just after removing the zipper.

 
Surgeons have always closed skin with sutures or staples, and this continues to be the standard practice in most cases. However, the use of such a traumatic and invasive technique does not provide ideal conditions for wound healing. The zipper that is now available may provide a more natural healing environment, because skin perforation and suture channel marks can be avoided, and trauma to the wound edges minimized. It may favour the zipper-closing technique that already in the first study there is no significant difference according to the infection between groups, and the cosmetic result is better. Clinically relevant differences will have to be clarified in forthcoming studies.

In summary, our analysis indicates that the cosmetic result is better with the non-invasive zipper technique compared with the intracutaneous method. The incidence of total infection was equal for the two techniques. In order to obtain a better cosmetic result, the zipper wound-closing technique can be recommended.


   Acknowledgments
 
The study was funded by grants from MEDCON.


   References
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
 References
 

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