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ORIGINAL ARTICLE
Year : 2022  |  Volume : 13  |  Issue : 3  |  Page : 449-456  

Comparative evaluation of efficacy of skin staples and conventional sutures in closure of extraoral surgical wounds in neck region: A double-blind clinical study


1 Department of Oral and Maxillofacial Surgery, Sinhgad Dental College and Hospital, Pune, Maharashtra, India
2 Department of Oral Medicine and Radiology, Buddha Institute of Dental Sciences and Hospital, Bengaluru, Karnataka, India
3 Department of Critical Care Medicine, Manipal Hospital, Bengaluru, Karnataka, India
4 Department of Oral Medicine and Radiology, Teerthanker Mahaveer Dental College and Research Centre, Moradabad, Uttar Pradesh, India
5 Department of Prosthodontics, College of Dentistry, Majmaah University, AlMajmaah, Saudi Arabia
6 Department of Oral and Maxillofacial Surgery, Dr. Supe Multispeciality Dental Clinic, Malkapur, Maharashtra, India

Date of Submission21-Jan-2021
Date of Acceptance09-Jul-2021
Date of Web Publication10-Dec-2022

Correspondence Address:
Dr. Amit Kumar Choudhary
Department of Critical Care Medicine, Manipal Hospital, Bengaluru, Karnataka
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/njms.njms_305_21

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   Abstract 


Background: The development of the skin stapling technique for surgical wound closure is less time-consuming than the conventional sutures.
Aim: This study aims to evaluate the efficacy of skin staples and 4-0 prolene conventional suture in closure of extraoral surgical wounds in neck region in elective maxillofacial surgery.
Materials and Methods: The study was conducted on a total of 60 patients, who were equally divided into three groups. In Group 1, wound closure was done using skin staples; in Group 2, wound closure was done using 4-0 prolene suture, and in Group 3, wound closure was done using both skin staples and 4-0 prolene suture. These groups were compared in terms of rate of wound closure; early postoperative pain; pain on the removal of staple and suture; rate of removal of staple and suture; scar evaluation by the clinician, patient, and two-blind observers on 15th day, 1 month, 3 months, and 6 months.
Results: The rate of closure was significantly faster in staple group than in suture group. There was no significant difference in the postoperative pain, pain on removal and rate of removal between the two methods of closure. However, within the groups, more postoperative pain was observed in wound with incision length of >5 cm. Initially, on 10th postoperative day, the appearance of scar was significantly better in suture group but after 6 months, scar was better in staple group.
Conclusion: The staple method of wound closure appears to be better than conventional suture in terms of rate of closure and scar appearance.

Keywords: Maxillofacial surgery, staple, sutures, wound healing


How to cite this article:
Pandey ND, Singh AK, Choudhary AK, Jina G, Thakare A, Supe NB. Comparative evaluation of efficacy of skin staples and conventional sutures in closure of extraoral surgical wounds in neck region: A double-blind clinical study. Natl J Maxillofac Surg 2022;13:449-56

How to cite this URL:
Pandey ND, Singh AK, Choudhary AK, Jina G, Thakare A, Supe NB. Comparative evaluation of efficacy of skin staples and conventional sutures in closure of extraoral surgical wounds in neck region: A double-blind clinical study. Natl J Maxillofac Surg [serial online] 2022 [cited 2023 Jan 26];13:449-56. Available from: https://www.njms.in/text.asp?2022/13/3/449/363064




   Introduction Top


Surgical wound closure is done to favor healing and yield a good aesthetic result with less chance of complications.[1] Historically, the earliest description of wound closure came from Sushruta as a process of tieing two ends of thread for union of wound edges with the help of needle and appropriate suturing material. Four methods of suturing techniques are described in ancient literature, known as seevan karma, as riju granthi (straight interrupted type), vellitaka (continous type), tunnasevani (zigzig or subcuticular type), and gophanika (interlocking type).[2]

One of the most important outcomes of wound repair is the long-term esthetic appearance of the scar. It is particularly relevant in maxillofacial surgery since the patients are very concerned regarding esthetic outcome of the cutaneous scar in this region. The most common method of wound closure in a maxillofacial surgery is the use of sutures, which is a time-honored method of wound closure and offers several advantages including familiarity, lower rate of dehiscence, and great tensile strength.[3] Earlier, there was a limited option for suturing material. But today more than 5000 different types of suturing materials are available in market which includes catgut, silk, prolene, etc., Prolene (polypropylene manufactured by Ethicon) is a synthetic nonabsorbable suture material used commonly for skin closure in maxillofacial region. Skin staples and topical adhesives are the recently developed techniques for wound closure.[4]

During the ancient period, insect mandibles were first used to close skin wounds which lead to the development of staple wound closure method. Mechanical suture devices were introduced in the United States by Steichen and Ravitch in 1973.[5] Stapling method of wound closure has been shown to be an excellent option in many situations.[6] They also have gained acceptance as alternatives to sutures for traumatic wounds. Multiple studies have shown equivalent outcomes when comparing staples to sutures in terms of cosmetic results, cost-effectiveness, and complications. The greatest advantage of staple is the speed of closure. They also have a lower rate of infection and foreign-body reaction. Thus the present study was undertaken to evaluate the efficacy of skin staples and 4-0 prolene conventional suture in closure of extraoral surgical wounds in neck region in elective maxillofacial surgery. However, deeper wounds require the use of absorbable sutures to reduce tension and close dead space before the placement of the skin staples[3] and hence the same was followed in the present study.


   Materials and Methods Top


The present prospective double-blind clinical study was carried out in the department of oral and maxillofacial surgery for 1½ years on a total of 60 patients who were further divided into three groups depending on the type of wound closure as (i) Group 1: Skin incision closure by skin staple; (ii) Group 2: Skin incision closure by 4-0 prolene suture; (iii) Group 3: Skin incision closure by both skin staple and 4-0 prolene suture. Group 1 and Group 2 were further sub-divided, depending upon the length of incision, into a (incision length <5 cm) and b (incision length >5cm). All the patients who required a minimum 2.5 cm skin incision length over the neck region for surgical management and who were not medically compromised, and who agreed to cooperate for the regular follow-up were included in the study. Patients with previous scar or lacerated wound over the site requiring incision and those with uncontrolled diabetes or history of long-term corticosteroid therapy and immunosuppressants were excluded from the study.

Ethical committee clearance was obtained from Guru Nanak Institute of Dental Sciences & Research's Institutional Ethical Committee with ref no. 2011/16 on 12.02.2012. Each patient was explained in detail about the study procedure and a written informed consent was obtained from each of them.

Procedure

All the surgical procedures were undertaken under general anesthesia by the same surgeon. After draping the patient, skin incision was marked with gention violet and length of the incision was measured with the help of reel silk and scale [Figure 1]. Skin incision was made with No. 10 blade with single stroke along the natural skin crease. Diathermy was used only in deeper tissues and never on the skin and subcutaneous tissues. To ligate bleeding vessels 2-0 silk suture was used, for periosteum, fascia, and muscle 2-0 vicryl suture was used, while at the subcutaneous level 3-0 vicryl suture was used in a continuous manner.
Figure 1: Clinical picture of the patient showing incision length measurement

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Skin closure by staple

The stapler used in the present study was Proximate® Plus MD (Ethicon Endo Surgery LLC) and the staple used was stainless steel with topspan length of 6.9 mm. While stapling, first the skin margins were approximated, slightly elevated, and everted with a tooth forcep to prevent inversion of the skin edges. Then the stapler was lightly placed onto the skin and the staple was fired. 5 mm of uniform distance was maintained between the adjacent staples [Figure 2]a and [Figure 2]b.
Figure 2: Clinical picture of patient showing (a) the application of staple for skin closure; and (b) uniform distance between the adjacent staples

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Skin closure by 4-0 Prolene suture

Suture used was NW 849 Prolene (Ethicon Non-absorbable monofilament Polypropylene) with 16 mm ½ Circle Round Bodied needle. Simple interrupted suture was placed in a conventional way and the bite was carefully taken on the two sides of the incision separately. Around 5 mm of uniform distance was maintained between the two adjacent sutures [Figure 3]. Total time of closure was noted with stopwatch between the first bite to the final knot.
Figure 3: Clinical picture of patient showing skin incision closure by 4-0 prolene suture

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Hemorrhage following skin closure and any adverse skin reactions if any to the suture or staple was recorded.

After care

Immediately after surgery, soframycin ointment was applied on the closed wound. Jelonet was then used over the ointment to cover the wound. Finally, sterile gauge was placed and closed with dynaplast. The dressing was changed to an open dressing after 2 days. Meticulous cleaning of wound with povidone-iodine solution was done and application of soframycin alone was then allowed till the period of removal of suture or staple. Patients were advised not to apply water over the area till the removal of suture/staple. Suture or staple was removed after 10 days. Prescribed drugs included ceftriaxone sulbactam 1.5 g, tinidazole 800 mg in selective cases, dexamethasone 8 mg, diclofenac sodium 75 mg, and omeprazole 40 mg. Tramadol hydrochloride 100 mg was used as rescue analgesics.

Following observations were made

  1. Rate of closure of skin wound: time taken for skin closure was noted and rate of closure of skin in cm/min was calculated
  2. Pain on 3rd, 5th, 7th, and 10th postoperative day were recorded as per Visual Analog Scale (VAS)[7]
  3. Pain on the removal of staple and suture using VAS score
  4. Rate of removal of staple and suture (staple was removed with a specially designed instrument called proximate extractor while suture was removed in a conventional manner) [Figure 4]
  5. Scar evaluation by clinician using Stony Brook Scar Evaluation Scale (SBSES) [Figure 5] on15th day [Figure 6]a and [Figure 6]b 1, 3 and 6 months [Figure 7]a and [Figure 7]b
  6. Evaluation of scar by the patient on 15th day, 1 month, 3 months, and 6 months using VAS on a 100-mm line with “worst scar” at the right end of the line and “best scar” at the left end of the line
  7. Evaluation of scar by two-blind observers-(Direct observation) using VAS on15th day, 1 month, 3 months, and 6 months: For this purpose, two departmental staff who were unaware of the type of closure employed were included in the study. They observed the scar from 4 feet distance in natural daylight and scored it on the 100 mm linear scale of VAS
  8. Evaluation of scar by two-blind observers-(Indirect observation) using VAS on15th day, 1 month, 3 months, and 6 months: For this purpose, digital photographs were projected on the screen by departmental projector with the same optimum projection setup so that the actual size of the photograph during evaluation was of 42”×54” and the same two persons who did a direct evaluation of scar were asked to evaluate the digital photographs of the scar using the same 100 mm linear scale of VAS from 10 feet distance
Figure 4: Clinical picture of patient showing removal of skin staple using proximate extractor

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Figure 5: Stony Brook Scar Evaluation Scale

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Figure 6: Postoperative clinical picture of scar on 10th day after removal of (a) staple; and (b) suture

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Figure 7: Postoperative clinical picture of scar after 6 month in (a) staple group; and (b) suture group

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SBSES measures long-term appearance of scar and is composed of five categories including width, height, color, suture marks and overall appearance [Figure 5]. Scars were evaluated on the basis of previously validated SBSES scale and the scores were calculated. In order to have uniformity of the photographs, pictures were taken by the same person repeatedly under the same situations, i.e., the camera was held at a distance of 2 feet from the object at 90° angle using the autofocus and autoflash settings in a bright daylight.

Statistical analysis

Student's unpaired t-test was used for group-wise comparisons, while Chi-square test was used for categorical comparisons. A “P” value of 0.05 or less was considered statistically significant.


   Results and Observations Top


Rate of closure

The mean rate of skin closure for Group 1 was 4.02 ± 0.89 cm/min and for Group 2 was 1.25 ± 0.25 cm/min. This difference was highly statistically significant (P < 0.001). However, there was no significant difference between 1a and 1b as well as 2a and 2b, and between Group 1 and Group 3 (staple), and between Group 2 and Group 3 (suture) [Table 1].
Table 1: Rate of closure

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Pain on 3rd, 5th, 7th, and 10th postoperative days

The decrease in postoperative pain was statistically significant from 3rd to 5th day at 1% level (P < 0.01) in staple group whereas in the suture group the decrease in postoperative pain was significant from 7th to 10th day (P < 0.01).

On 3rd postoperative day, the difference in the average pain score between group 1a and 1b and between 2a and 2b was statistically significant at 10% level (P < 0.05), while it was not significant for other group comparisons.

On 5th postoperative day, the difference in the average pain score between groups 1a and 1b was statistically significant (P < 0.05) while for other group comparisons, it was not significant.

On 7th postoperative day, there was no statistically significant difference between all the Groups.

On 10th postoperative day, the difference in the average pain score was statistically significant between Group 1a and 1b and Group 2a and 2b (P < 0.05) [Table 2].
Table 2: Comparison of pain score (Visual Analogue Scale) between groups on early postoperative days

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Pain on removal of staple and suture

There was no statistically significant difference in the average pain score during removal between Group 1 and 2, Group 2 and 3, and Group 1 and 3. However, it was statistically significant between Group 1a and 1b (P < 0.02) [Table 3].
Table 3: Comparison of pain on removal and rate of removal between all the groups

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Rate of removal of staple and suture in cm/min

The difference in the average rate of removal between Group 1 and 3(staple) was significant (P < 0.05). The difference in the average rate of removal between Group 1 and 2 and Group 2 and 3 as well as between Group 1a and 1b and Group 2a and 2b was not statistically significant [Table 3].

Evaluation of scar by the clinician using Stony Brook Scar Evaluation Scale

The difference of SBSES score between 15th day to 6 months was highly significant (P < 0.01) for Group 1. However, the difference in the scores was not significant for both Group 2 and 3. The overall average of SBSES score of Group 2 was significantly greater than that of Group 1 (P < 0.02) on 15th day. All other comparisons (between 1a and 1b, 2a and 2b, between 1 and 3, and between 2and 3) were statistically insignificant (P > 0.05). Furthermore, there was no statistically significant difference in overall average of SBSES score between any groups after 1 month, 3 months, and 6 months [Table 4].
Table 4: Comparison of Stony Brook Scar Evaluation Scale score among the groups on different follow-up periods

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Evaluation of scar by the patient

The decrease in the VAS scores was found to be statistically significant from 10th day to 3 months postoperatively in Group 1 (P < 0.001) and staple of Group 3 (P < 0.02). However, the difference in the score was not significant for the other groups. The difference in the mean VAS score was found to be statistically significant between Group 1a and 1b at 10% level on 15th day and 3 months, while it was significant at 5% level on 6 months (P < 0.05). However, there was no significant difference in the mean VAS score between any groups at other time periods [Table 5].
Table 5: Comparison of scar evaluation by the patient using Visual Analogue Scale among the groups on different follow-up periods

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Direct observation of scar by the two-blind observers

On day 10th, observer 1 found the mean difference in the VAS score between Group 1 and 2 to be statistically significant at 10% level (P < 0.1), but it was not significant between Group 1 and 3 (staple) and Group 2 and 3 (suture). On the other hand, Observer 2 did not find any significant difference in the mean VAS score on 10th day between any groups. However, both the Observers did not find a significant difference in the mean VAS score on 15th day, 1 month, 3 months, and 6 months between any of Groups [Table 6].
Table 6: Comparison of scar evaluation by 2 blind observers (direct observation) using Visual Analogue Scale among the groups on different follow-up periods

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Indirect observation of scar by the two-blind observers

Observer 1 found the mean difference in the VAS score between Group 1 and 2 to be statistically significant at 10% level (P < 0.1) on 10th day, but it was not significant between Group 1 and 3 (staple) and Group 2 and 3 (suture). However, Observer 2 did not find any significant difference in the mean VAS score on 10th day between any groups. Observer 1 did not find any significant difference in the mean VAS score on 15th day between any groups, however, Observer 2 found a significant difference in the mean VAS score between Group 1 and 3 (staple) at 10% level.(P < 0.1). Both the Observers did not find a significant difference in the mean VAS score after 1 month, 3 months, and 6 months between the Groups [Table 7].
Table 7: Comparison of scar evaluation by 2 blind observers (indiirect observation) using Visual Analogue Scale among the groups on different follow-up periods

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   Discussion Top


In the present study, different types of cases were included which were broadly categorized into benign, malignant, trauma, and others. Among all the cases, there were 10 benign cases, 20 malignant cases, 25 trauma cases and 5 other cases. It was found that the cases were evenly distributed between two age groups of <30 years and >30 years. The youngest patient in the study was 16-year-old and the oldest was 60 years old. In addition, it was found that the cases were evenly distributed in terms of required incision length for surgical management.

Rate of closure

The mean rate of closure for group 1 in the present study was 4.02 cm/min and for group 2 was 1.25 cm/min (P < 0.001) which is highly statistically significant suggesting that stapler requires much less closure time than 4-0 prolene suture. Similar results were obtained by Gatt et al.,[8] who found the mean rate of wound closure using sutures to be 4.2 cm/min, and using staples it was at a much faster rate of 22.5 cm/min in their linear abdominal incision surgeries. These results are in accordance with the studies by Orlinsky et al.,[5] George and Simpson,[9] Stockley and Elson,[10] Suresh et al.,[11] and Kathare and Shinde.[12] Thus, it can be concluded that once the expertise is achieved for staple application, it becomes a convenient and easy procedure for the surgeon.

Shuster[13] have found in their study that lacerations were closed 2.7 times faster by the staple method as compared to the suture method (P < 0.001). Similarly, Batra et al. in 2016[14] and Kathare and Shinde in 2019[12] have found staple method to be 10 times and 5 times faster than suture method in their respective studies. In the present study, the staple method was found to be 4 times faster than suture method.

Postoperative pain

In the present study, there was no significant difference in the postoperative pain on 3rd, 5th, 7th and 10th days between staple and suture groups. Ananda et al.[15] have observed more postoperative pain in the suture group than in the staple group. However, in the present study, more postoperative pain was observed in patients with incision length of >5 cm. No other studies have mentioned any detail in this regard.

Rate of removal

Time taken for removal was noted and rate of removal was calculated in cm/min in the present study. There was no significant difference in the average rate of removal between staple and suture in the present study. No other studies have mentioned about rate of removal in detail.

Pain on removal of staple and suture

In the present study, no significant difference was observed in pain score during removal of staple and suture which may be because a well-designed staple remover was used. Similar observation was made by Batra et al.[14] and Gatt et al.[8] In contrast to this, Selvadurai et al.,[16] George and Simpson,[9] and Stockley and Elson[10] have found staple removal to be more painful than suture. However, Kathare and Shinde[12] have observed pain to be less during staple removal than suture.

Evaluation of scar

Scar evaluation was done in the present study by clinician, patient himself, and 2 blind observers by direct and indirect methods. SBSES was used for scar evaluation by the clinician. On the 15 postoperative day and then after 1 month, 3 months, and 6 months, scars were evaluated on the basis of previously validated SBSES scale and the scores were calculated and compared. The difference of SBSES score between 15th day and 6 months was significant (P < 0.01) for staple group. However, the difference in the scores was not significant for other groups. The overall average of SBSES score of suture group was greater than that of staple group (P < 0.02) on 15th postoperative day, however, after 6 months the SBSES score of staple group was slightly greater than suture group. This may suggest that initially scar appearance in suture group is better but at a later stage, scar appearance in staple group has better esthetics. All other comparisons were insignificant (P > 0.05). Similarly, Ghosh et al.[17] have found no significant difference in the scar appearance after 3 months while comparing silk sutures with skin staples using VAS.

Patients evaluated the scar on the day of suture/staple removal, i.e., 10th postoperative day followed by 15 days, then after 1 month, 3 months, and 6 months. They were asked to observe the scar in a plane mirror in natural daylight and score it on the 100 mm linear scale of VAS (the linear analog scale had the words “worst imaginable scar” on the right-hand side and “best possible scar” on the left-hand side). The decrease in the VAS scores was found to be statistically significant from 10th postoperative day to 3 months in staple group (P < 0.001). However, the difference in the score was not significant for the other groups. The mean difference in the VAS score was significant at 10% level in between group 1a and 1b on 15th day and 3 months, whereas it was not statistically significant between group 1 and 2, group 1 and 3 (staple), group 2 and 3 (suture), and group 2a and 2b on other time periods.

While evaluating scar using direct and indirect observation method by two-blind observers, it was found that on 10th postoperative day, the appearance of scar was significantly better in suture group than staple group but after 6 months, scar was better in appearance in staple group, but this difference was not significant.


   Conclusion Top


The present study concludes that the rate of closure (in cm/min) of skin with staple is significantly higher than that of 4-0 prolene suture (P < 0.001). It also concludes that in the early postoperative periods (i.e., between 10 to15 days), skin wounds closed with 4-0 prolene suture offers superior esthetics than staple but the long-term appearance of scar is comparable between both the groups. and slightly better between the two methods of closure in the neck region of the body.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
   References Top

1.
Cochetti G, Abraha I, Randolph J, Montedori A, Boni A, Arezzo A, et al. Surgical wound closure by staples or sutures? Systematic review. Medicine (Baltimore) 2020;99:e20573.  Back to cited text no. 1
    
2.
Bhattacharya S. Wound healing through the ages. Indian J Plast Surg 2012;45:177-9.  Back to cited text no. 2
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Lloyd JD, Marque MJ, Kacprowicz RF. Closure techniques. Emerg Med Clin N Am 2007;25:73-81.  Back to cited text no. 3
    
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Hochberg J, Meyer KM, Marion MD. Suture choice and other methods of skin closure. Surg Clin North Am 2009;89:627-41.  Back to cited text no. 4
    
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Orlinsky M, Goldberg RM, Chan L, Puertos A, Slajer HL. Cost analysis of stapling versus suturing for skin closure. Am J Emerg Med 1995;13:77-81.  Back to cited text no. 5
    
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Menaker GM. Wound closure materials in the new millennium. Curr Probl Dermatol 2001;13:90-5.  Back to cited text no. 6
    
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Quinn JV, Drzewiecki AE, Steill IG, Elmslie TJ. Appearance scales to measure the cosmetic outcomes of healed lacerations. Am J Emerg Med 1995;13:229-31.  Back to cited text no. 7
    
8.
Gatt D, Quick CR, Owen-Smith MS. Staples for wound closure: A controlled trial. Ann R Coll Surg Engl 1982;67:318-20.  Back to cited text no. 8
    
9.
George TK, Simpson DC. Skin wound closure with staples in the accident and emergency department. J R Coll Surg Edinb 1985;30:54-6.  Back to cited text no. 9
    
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Stockley I, Elson RA. Skin closure using staples and nylon sutures: A comparison of results. Ann R Coll Surg Engl 1987;69:76-8.  Back to cited text no. 10
    
11.
Suresh G, Rao KS, Sharma SM, Prasad RB. Use of skin staples in craniofacial and head and neck surgery: A prospective study. J Maxillofac Oral Surg 2008;7:346-50.  Back to cited text no. 11
    
12.
Kathare SS, Shinde ND. A comparative study of skin staples and conventional sutures for abdominal skin wound closures. Int Surg J 2019;6:2168-72.  Back to cited text no. 12
    
13.
Shuster M. Comparing skin staples to sutures. Can Fam Physician 1989;35:505-9.  Back to cited text no. 13
    
14.
Batra J, Bekal RK, Byadgi S, Attresh G, Sambyal S, Vakade CD. Comparison of skin staples and standard sutures for closing incisions after head and neck cancer surgery: A double-blind, randomized and prospective study. J Maxillofac Oral Surg 2016;15:243-50.  Back to cited text no. 14
    
15.
Ananda BB, Vikram J, Ramesh BS, Khan HM. A comparative study between conventional skin sutures, staples adhesive skin glue for surgical skin closure Int Surg J 2019;6:775-82.  Back to cited text no. 15
    
16.
Selvadurai D, Wildin C, Treharne G, Choksy SA, Heywood MM, Nicholson ML. Randomised trial of subcuticular suture versus metal clips for wound closure after thyroid and parathyroid surgery. Ann R Coll Surg Engl 1997;79:303-6.  Back to cited text no. 16
    
17.
Ghosh A, Nanjappa M, Nagaraj V, Rajkumar GC. Comparison between stainless steel staples and silk sutures for primary closure of skin in patients undergoing neck dissection: A comparative clinical study. Contemp Clin Dent 2015;6:S51-5.  Back to cited text no. 17
    


    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]



 

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