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Polyglactin 910 versus irradiated polyglactin 910 for subcuticular closure in elective surgeries: a randomized double-blind study

Surgery and sutures are inseparable. Although minimal access surgery is picking up still there are large number of situations where open surgery has to be undertaken in an elective and emergency setting. Every year several million people undergo open surgeries worldwide. Surgery inevitably results in an abdominal scar. Nowadays people of all ages give an extreme importance to the appearance of the scar in addition to pain, tenderness and itching. The appearance of a scar is always of aesthetic importance to patients. The scar is the only reminder of surgery to patients.

Nowadays people of all ages give an extreme importance to the appearance of the scar in addition to pain, tenderness and itching. The appearance of a scar is always of aesthetic importance to patients. The scar is the only reminder of surgery to patients.
The wound closure technique should be based on evidence and not only on the surgeon's preference and tradition. The skin closure methods used should be able to restore the physical integrity and function of injured tissue. There are many methods of the skin closure like sutures, staplers, tapes and adhesive compounds. There is always careful selection of suture material. Choosing suture materials and adhering to good wound closure technique will provide good wound healing. 1 A suture is defined as a biomaterial device, natural or synthetic, used to approximate tissues together following separation by surgery or trauma. It is also used to denote the method of mechanical wound closure.
The absorbable sutures most commonly used are the synthetic sutures: polyglactin 910, irradiated polyglactin 910, polyglycolic acid, polydioxanone, polytrimethylene carbonate. Catgut is less frequently used now, but it does have some specific uses. In the old times, absorbable sutures were used for deep sutures. However, with advances in research, nowadays absorbable sutures have also been used for percutaneous closure of wounds in adults and children.
Halsted, first described the subcuticular technique which is an elegant but very difficult technique. This suture technique is very valuable when a suture is to be kept in place for more than one week. The advantage of subcuticular sutures in younger patients is that skin is comparatively soft and supple, and this technique helps in good cosmetic results and also good healing. 2 The main aims of skin closure are good tissue approximation, ease of performance, good patient acceptability, minimal scar and good cosmetic appearance. 3 There are limited studies conducted comparing the different suture materials in one suturing technique in the patients that are posted for elective surgery. This study has been designed to compare the polyglactin 910 (Vicryl) and irradiated polyglactin 910 (Rapide Vicryl) for subcuticular skin closure in elective surgeries which will further add to the knowledge of surgical fraternity.
Comparative study to evaluate Irradiated Polyglactin 910 (Vicryl Rapide) versus polyglactin 910 (Vicryl) for subcuticular skin closure in patients of elective surgeries and to note post-operative wound inflammation, pain, dehiscence and quality of scar.
In both the groups comparative study was done in terms of-Pain, wound infection, wound dehiscence, purulent discharge, quality of scar.

METHODS
An interventional randomized comparative study was conducted in the department of general surgery at Sri Guru Ram Das institute of medical sciences and research, Sri Amritsar from April 2020 to June 2020. Approval was taken from hospital ethics committee.
Informed written consent was taken from the patients. Sixty consecutive cases of elective surgeries were divided into 2 groups with 30 patients each. Patients were randomized into one of the two groups by envelope method. Equal number of labels A (30) and B (30) were randomly placed in 60 envelopes.
The patients were asked to pick up an envelope from the basket. The number of participants was labelled on the envelope. The envelope was opened only at the time of surgery and the suture material according to the label code was used. The suturing was done by one surgeon and the post-operative observation was done by another surgeon in order to ensure double blinding.
Inclusion criteria included written informed consent, either sex, patients scheduled for elective surgery.
Exclusion criteria excluded patients unwilling to participate/unable to understand the visual analogue scale, Patients having lacerated wounds with skin loss, all emergencies laparotomies, pregnancy (in women), current immunosuppressive therapy (more than 40 mg of a corticosteroid per day or azathioprine), chemotherapy within 2 weeks before operation, previous upper abdominal surgery, chronic obstructive pulmonary disease (COPD), morbid obesity and refusal of consent A detailed pre-anesthetic evaluation and relevant investigations were obtained. All patients received alprazolam 0.5 mg orally and ranitidine 150 mg orally night before surgery. The whole procedure and risks involved in the procedure were fully explained to the patients and relatives. Informed written consent was taken. Preoperatively patient was introduced to the concept of visual analogue scale (VAS). All patients had undergone similar general/spinal anesthetic procedure.

Details of surgical procedure
Subcuticular skin closure was done at the end of the surgery using either 3-0 polyglactin 910 (Vicryl) as Figure 1 or 3-0 irradiated polyglactin (Vicryl Rapide) as shown in Figure 2 with cutting needle.

Surgical technique
After the completion of elective surgery, skin closure was done in a subcuticular running suture technique. The suture was secured at one end of the incision. Then the same plane was maintained throughout the entire length of the incised wound, taking horizontal mirror image bites. The suture was tightened after each pair of bites. At the end of the incision a bite was taken through the adjoining skin and suture was buried to secure it. An aseptic gauze dressing was done at the end of the procedure in Figure 3.

Post-operative period
Following parameters were checked post-operatively: Post-operative pain assessment was based on a 0 to 10 visual analogue scale. The post-operative pain was compared in both groups on day 3 rd and day 7 th .   Post-operatively the wound was inspected on day 3, 5, 7 and again 3 weeks after surgery. At each wound inspection, the following features are looked for: Erythema of skin, oedema, tenderness, local rise of temperature, sinus formation, abscess formation and wound gaping. The patient was discharged after wound inspection on post-operative day 7.
At each wound inspection, the findings were recorded on observation chart according to following scoring system: 0. No features of inflammation, normal healing. 1. Redness (Erythema), 2. Redness and edema, 3. Redness, edema, tenderness and local rise of temperature, 4. Above features with sinus formation, 5. Above features and abscess formation, 6. Above features with wound gaping, 7. Quality of scar.
Change in score between day 3 and day 7 (range -6 to +6), reduction in score: 1. <50% 2. 50% or more On follow up of the patient. Wound was again inspected at the end of 3 weeks to see the quality of scar.
The results were compiled at the end of the study and analyzed statistically. The post-operative observations were supervised by post graduate companions or senior fraternity from the same department of the same institute for the evaluation of the same.

Statistical analysis
Statistical analysis was done using SPSS version 17.0.to compare prevalence chi square test was used.

RESULTS
The present study is the comparison of polyglactin 910 and irradiated polyglactin 910 for subcuticular closure in elective surgery. 60 consecutive patients of age group 18-70 years and of both genders were included in this study after taking informed consent from them. These patients were admitted in the department of surgery at Sri Guru Ram Das institute of medical sciences and research, Vallah, Amritsar for various surgical procedures. The following observations were made in this study.
Both the groups were comparable in age, sex distribution of cases and post-operative pain on 3 rd and 7 th day with no significant statistical difference between them.       Comparison of polyglactin 910 (Vicryl) and irradiated polyglactin 910 (Rapide Vicryl) has had various outcomes with some studies showing both to be equally good whereas others showed irradiated polyglactin 910 to be more superior than polyglactin 910. Limited studies are available on the use of irradiated polyglactin 910 and polyglactin 910 for subcuticular skin closure in elective surgeries which therefore warrants further research in this field.

Limitations
Comparison of sutures in a particular surgery and large sample size is needed.

CONCLUSION
Present study concluded that irradiated polyglactin 910 (Rapide Vicryl) was a better choice of suture material than polyglactin 910 (Vicryl) for subcuticular skin closure in patients undergoing elective surgeries. However, more studies with large number of subjects are needed for further substantiate for results.