- Email: [email protected]
A SINGLE BLIND, PROSPECTIVE, RANDOMIZED TRIAL COMPARING N-BUTYL 2-CYANOACRYLATE TISSUE ADHESIVE (INDERMIL) AND SUTURES FOR SKIN CLOSURE IN HAND SURGERY
A SINGLE BLIND, PROSPECTIVE, RANDOMIZED TRIAL COMPARING N-BUTYL 2-CYANOACRYLATE TISSUE ADHESIVE (INDERMIL) AND SUTURES FOR SKIN CLOSURE IN HAND SURGERY S. SINHA, M. NAIK, V. WRIGHT, J. TIMMONS and A. C. CAMPBELL From the Department of Orthopaedic Surgery, Monklands Hospital, Airdrie, UK
Fifty patients underwent a variety of hand operations and were randomized for wound closure either with tissue adhesive (Indermil) or sutures. The two treatment groups had similar demographic characteristics and similar outcomes at the 2 and 6 week postoperative assessments which were performed by a designated tissue viability nurse blinded to the method of closure. Five minor wound dehiscences occurred: three in the adhesive group and two in the suture group. No infection occurred in either group. In conclusion, the study demonstrates tissue adhesive is as effective as suture in this type of hand surgery. Journal of Hand Surgery (British and European Volume, 2001) 26B: 3: 264–265 The cyanoacrylate group of adhesives were first described in 1949, but it was not until 1959 that their potential as adhesives for surgical procedures was reported (Coover et al., 1959). These adhesives polymerize in an exothermic reaction on contact with a fluid or basic substance and form a strong bond. Investigations performed in the 1960s and 1970s concluded that the shorter-chain cyanoacrylate monomers were tissue toxic, and therefore had limited clinical use. However, longer-chain n-butyl 2-cyanoacrylates caused no toxic effects or carcinogenicity and were found to be a better alternative for topical skin closure. While the use of n-butyl 2-cyanoacrylate tissue adhesive (Indermil, Loctite, Ireland) for small facial lacerations is accepted (Quinn et al., 1993), no study has analysed its application in hand surgery. The purpose of this single blind, prospective, randomized study was to compare the outcome of hand surgery wounds repaired with a tissue adhesive (Indermil) or with standard wound closure techniques.
wound edges. The wound was then held together for 30 seconds to allow for complete polymerization. Sutured wounds were closed with 4–0 monofilament suture with standard sterile techniques. Patients were reviewed in the out-patient department at 7 to10 days for suture removal and/or a wound inspection. Patients were subsequently assessed at 2 and 6 weeks post-surgery by a designated tissue viability nurse who was blinded to the method of closure. Wounds were evaluated for evidence of infection, dehiscence, pain on movement, and cosmesis on a validated standard 100 mm visual analog scale (Quinn et al., 1997).
RESULTS Of the 50 study participants, six were lost to follow-up (five in the adhesive group and one in the suture group). The two study groups had similar demographic characteristics (Table 1) and had undergone a similar spectrum of hand surgical procedures (Table 2). The two treatment groups had similar wound outcome at both the 2 and the 6 week assessments (Table 3). There was no significant difference in the cosmetic outcome assessment, but five minor wound dehiscences (gaping of 1–2 mm) occurred. Three of these were in the tissue adhesive group and two were in the suture group. These wounds closed spontaneously without any adverse outcomes and no infection occurred in either group. Four patients volunteered that they thought the glue was a good idea as it avoided the need for suture removal.
PATIENTS AND METHODS Fifty patients who underwent a variety of hand operations in the day surgery unit at Monklands Hospital, Airdrie over a 6 month period formed the study group. Exclusion criteria included Dupuytren’s contracture, re-operations and patients with a known history of skin allergy, keloid formation, diabetes or corticosteroid use. The study was approved by the hospital review board and informed consent was obtained from each patient. All the cases had local anaesthetic infiltration with or without general anaesthesia and a tourniquet was used in all cases. Patients were randomized to wound adhesive or suture on the basis of 50 previously prepared and sealed envelopes containing slips for either suture closure or the use of Indermil (25 of each). Wounds closed with Indermil were manually approximated with skin hooks and adhesive was applied sparingly along the
Table 1—Demographic characteristics of the 2 study groups
Number Mean (SD) Age (years) Male : Female
264
Tissue adhesive
Suture
20 49 (9) 5 : 15
24 51 (17) 4 : 20
TISSUE ADHESIVE FOR WOUND CLOSURE
265
Table 2—Case spectrum Tissue adhesive
Suture
Carpal tunnel syndrome Trigger finger De Quervain’s tenosynovitis Ganglions of wrist and hand Cysts of fingers
10 4 0 4 2
12 2 2 7 1
Total
20
24
Table 3—Clinical outcomes in the 2 study groups
Mean VAS cosmesis scores* Infection Dehiscence Adverse wound outcomes
Tissue adhesive
Suture
81 mm 0 3 0
87 mm 0 2 0
*0=worst cosmesis, 100=perfect cosmesis.
DISCUSSION Indermil is maintained in a liquid state by an acidic stabilizer which inhibits cross-linkage of molecules. Partly ionised molecules of water, which are normally found on all surfaces exposed to the atmosphere, neutralize this inhibitor. When Indermil is applied to the tissue surface the inhibitor is therefore neutralized and polymerization of the adhesive is completed in about 10 seconds. Cyanoacrylate tissue adhesives have been used for a number of medical applications, including traumatic laceration repair (Applebaum et al., 1993), bronchopleural fistula repair (Scappaticci et al., 1994), pulmonary resections (Sabanathan et al., 1993), repair of myocardial tears (Padro et al., 1993) and mesh fixation for inguinal hernia repair (Farouk et al., 1996). Tissue adhesive wound repair is a topical closure and care is required to ensure that the wound edges are well apposed so that no adhesive gets in between the wound edges. If this happens, not only will wound healing be impaired (epithelialization is prevented) but foreign body reactions can occur (Edlich et al., 1971; Toriumi et al., 1991). When used properly for topical wound closure, tissue adhesives result in fewer foreign body reactions than sutures, and can also decrease the infection rates of contaminated wounds by their antimicrobial properties against gram-positive organisms (Quinn et al., 1995; Quinn et al., 1996). In addition, the risk of a needle stick injury is eliminated and there is
no need for the patient to return for removal of sutures; this may have accounted for the five patients lost to follow-up in the adhesive group. These factors, along with their relatively low cost, make tissue adhesives an economical method of wound repair, with strong patient and physician preference (Osmond et al., 1995). Evaluation of patients in the two groups of our study showed similar wound outcomes. The incidence of minor gaping or dehiscence was similar in the two groups and there was no evidence of an increased wound infection rate. No benefits in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this article. References Applebaum JS, Zalut T, Applebaum D (1993). The use of tissue adhesion for traumatic laceration repair in the emergency department. Annals of Emergency Medicine, 22: 1190–1192. Coover HW, Joyner FB, Shearer NH, Wicker TH (1959) Chemistry and performance of cyanoacrylate adhesive. Journal of Society of Plastic Surgeons of England, 15: 5–6. Edlich RF, Thul J, Prusak M, Panek P, Madden J, Wangensteen OH (1971). Studies in the management of the contaminated wound VIII. American Journal of Surgery, 117: 394–397. Farouk R, Drew PJ, Qureshi A, Roberts AC, Duthie GS, Monson JRT (1996). Preliminary experience with butyl 2-cyanoacrylate adhesive in tension free hernia repair. British Journal of Surgery, 83: 1100. Osmond MH, Klassen TP, Quinn JV (1995). Economic comparison of a tissue adhesive and suturing in the repair of pediatric facial lacerations. Journal of Paediatrics, 126: 892–895. Padro JM, Mesa JM, Silvestre J et al. (1993). Subacute cardiac rupture: repair with a sutureless technique. Annals of Thoracic Surgery, 55: 20–24. Quinn JV, Drzewiecki A, Li MM et al. (1993). A randomised, controlled trial comparing tissue adhesive with suturing in the repair of pediatric facial lacerations. Annals of Emergency Medicine, 22: 1130–1135. Quinn JV, Maw JL, Wells GA (1997). Outcome measures in clinical wound studies: the reliability of cosmesis scales with determination of a minimal clinically important difference. Academic Emergency Medicine, 4: 410–411. Quinn JV, Osmond MH, Yurack J, Moir PJ (1995). N-2 butylcyanoacrylate: risk of bacterial contamination with an appraisal of its antimicrobial effects. Journal of Emergency Medicine, 13: 581–585. Quinn JV, Ramotar K, Osmond MH (1996). Antimicrobial effects of a new tissue adhesive. Academic Emergency Medicine, 3: 536–537. Sabanathan S, Eng J, Richardson J (1993). The use of tissue adhesives in pulmonary resections. European Journal of Cardiothoracic Surgery, 7: 657–660. Scappaticci E, Ardissone F, Ruffini E, Baldi S, Mancuso M (1994). Postoperative bronchopleural fistula: endoscopic closure in 12 patients. Annals of Thoracic Surgery, 57: 119–122. Toriumi DM, Raslan WF, Friedman M, Tardy ME (1991). Variable histotoxicity of histoacryl when used in a subcutaneous site. Laryngoscope, 101: 339–343.
Received: 3 October 2000 Accepted after revision: 25 January 2001 Mr S. Sinha, Department of Orthopaedics, Monklands District General Hospital, Monkscourt Avenue, Airdrie ML6 0JS, UK. E-mail: [email protected] # 2001 The British Society for Surgery of the Hand doi: 10.1054/jhsb.2001.0572, available online at http://www.idealibrary.com on
Fifty patients underwent a variety of hand operations and were randomized for wound closure either with tissue adhesive (Indermil) or sutures. The two treatment groups had similar demographic characteristics and similar outcomes at the 2 and 6 week postoperative assessments which were performed by a designated tissue viability nurse blinded to the method of closure. Five minor wound dehiscences occurred: three in the adhesive group and two in the suture group. No infection occurred in either group. In conclusion, the study demonstrates tissue adhesive is as effective as suture in this type of hand surgery. Journal of Hand Surgery (British and European Volume, 2001) 26B: 3: 264–265 The cyanoacrylate group of adhesives were first described in 1949, but it was not until 1959 that their potential as adhesives for surgical procedures was reported (Coover et al., 1959). These adhesives polymerize in an exothermic reaction on contact with a fluid or basic substance and form a strong bond. Investigations performed in the 1960s and 1970s concluded that the shorter-chain cyanoacrylate monomers were tissue toxic, and therefore had limited clinical use. However, longer-chain n-butyl 2-cyanoacrylates caused no toxic effects or carcinogenicity and were found to be a better alternative for topical skin closure. While the use of n-butyl 2-cyanoacrylate tissue adhesive (Indermil, Loctite, Ireland) for small facial lacerations is accepted (Quinn et al., 1993), no study has analysed its application in hand surgery. The purpose of this single blind, prospective, randomized study was to compare the outcome of hand surgery wounds repaired with a tissue adhesive (Indermil) or with standard wound closure techniques.
wound edges. The wound was then held together for 30 seconds to allow for complete polymerization. Sutured wounds were closed with 4–0 monofilament suture with standard sterile techniques. Patients were reviewed in the out-patient department at 7 to10 days for suture removal and/or a wound inspection. Patients were subsequently assessed at 2 and 6 weeks post-surgery by a designated tissue viability nurse who was blinded to the method of closure. Wounds were evaluated for evidence of infection, dehiscence, pain on movement, and cosmesis on a validated standard 100 mm visual analog scale (Quinn et al., 1997).
RESULTS Of the 50 study participants, six were lost to follow-up (five in the adhesive group and one in the suture group). The two study groups had similar demographic characteristics (Table 1) and had undergone a similar spectrum of hand surgical procedures (Table 2). The two treatment groups had similar wound outcome at both the 2 and the 6 week assessments (Table 3). There was no significant difference in the cosmetic outcome assessment, but five minor wound dehiscences (gaping of 1–2 mm) occurred. Three of these were in the tissue adhesive group and two were in the suture group. These wounds closed spontaneously without any adverse outcomes and no infection occurred in either group. Four patients volunteered that they thought the glue was a good idea as it avoided the need for suture removal.
PATIENTS AND METHODS Fifty patients who underwent a variety of hand operations in the day surgery unit at Monklands Hospital, Airdrie over a 6 month period formed the study group. Exclusion criteria included Dupuytren’s contracture, re-operations and patients with a known history of skin allergy, keloid formation, diabetes or corticosteroid use. The study was approved by the hospital review board and informed consent was obtained from each patient. All the cases had local anaesthetic infiltration with or without general anaesthesia and a tourniquet was used in all cases. Patients were randomized to wound adhesive or suture on the basis of 50 previously prepared and sealed envelopes containing slips for either suture closure or the use of Indermil (25 of each). Wounds closed with Indermil were manually approximated with skin hooks and adhesive was applied sparingly along the
Table 1—Demographic characteristics of the 2 study groups
Number Mean (SD) Age (years) Male : Female
264
Tissue adhesive
Suture
20 49 (9) 5 : 15
24 51 (17) 4 : 20
TISSUE ADHESIVE FOR WOUND CLOSURE
265
Table 2—Case spectrum Tissue adhesive
Suture
Carpal tunnel syndrome Trigger finger De Quervain’s tenosynovitis Ganglions of wrist and hand Cysts of fingers
10 4 0 4 2
12 2 2 7 1
Total
20
24
Table 3—Clinical outcomes in the 2 study groups
Mean VAS cosmesis scores* Infection Dehiscence Adverse wound outcomes
Tissue adhesive
Suture
81 mm 0 3 0
87 mm 0 2 0
*0=worst cosmesis, 100=perfect cosmesis.
DISCUSSION Indermil is maintained in a liquid state by an acidic stabilizer which inhibits cross-linkage of molecules. Partly ionised molecules of water, which are normally found on all surfaces exposed to the atmosphere, neutralize this inhibitor. When Indermil is applied to the tissue surface the inhibitor is therefore neutralized and polymerization of the adhesive is completed in about 10 seconds. Cyanoacrylate tissue adhesives have been used for a number of medical applications, including traumatic laceration repair (Applebaum et al., 1993), bronchopleural fistula repair (Scappaticci et al., 1994), pulmonary resections (Sabanathan et al., 1993), repair of myocardial tears (Padro et al., 1993) and mesh fixation for inguinal hernia repair (Farouk et al., 1996). Tissue adhesive wound repair is a topical closure and care is required to ensure that the wound edges are well apposed so that no adhesive gets in between the wound edges. If this happens, not only will wound healing be impaired (epithelialization is prevented) but foreign body reactions can occur (Edlich et al., 1971; Toriumi et al., 1991). When used properly for topical wound closure, tissue adhesives result in fewer foreign body reactions than sutures, and can also decrease the infection rates of contaminated wounds by their antimicrobial properties against gram-positive organisms (Quinn et al., 1995; Quinn et al., 1996). In addition, the risk of a needle stick injury is eliminated and there is
no need for the patient to return for removal of sutures; this may have accounted for the five patients lost to follow-up in the adhesive group. These factors, along with their relatively low cost, make tissue adhesives an economical method of wound repair, with strong patient and physician preference (Osmond et al., 1995). Evaluation of patients in the two groups of our study showed similar wound outcomes. The incidence of minor gaping or dehiscence was similar in the two groups and there was no evidence of an increased wound infection rate. No benefits in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this article. References Applebaum JS, Zalut T, Applebaum D (1993). The use of tissue adhesion for traumatic laceration repair in the emergency department. Annals of Emergency Medicine, 22: 1190–1192. Coover HW, Joyner FB, Shearer NH, Wicker TH (1959) Chemistry and performance of cyanoacrylate adhesive. Journal of Society of Plastic Surgeons of England, 15: 5–6. Edlich RF, Thul J, Prusak M, Panek P, Madden J, Wangensteen OH (1971). Studies in the management of the contaminated wound VIII. American Journal of Surgery, 117: 394–397. Farouk R, Drew PJ, Qureshi A, Roberts AC, Duthie GS, Monson JRT (1996). Preliminary experience with butyl 2-cyanoacrylate adhesive in tension free hernia repair. British Journal of Surgery, 83: 1100. Osmond MH, Klassen TP, Quinn JV (1995). Economic comparison of a tissue adhesive and suturing in the repair of pediatric facial lacerations. Journal of Paediatrics, 126: 892–895. Padro JM, Mesa JM, Silvestre J et al. (1993). Subacute cardiac rupture: repair with a sutureless technique. Annals of Thoracic Surgery, 55: 20–24. Quinn JV, Drzewiecki A, Li MM et al. (1993). A randomised, controlled trial comparing tissue adhesive with suturing in the repair of pediatric facial lacerations. Annals of Emergency Medicine, 22: 1130–1135. Quinn JV, Maw JL, Wells GA (1997). Outcome measures in clinical wound studies: the reliability of cosmesis scales with determination of a minimal clinically important difference. Academic Emergency Medicine, 4: 410–411. Quinn JV, Osmond MH, Yurack J, Moir PJ (1995). N-2 butylcyanoacrylate: risk of bacterial contamination with an appraisal of its antimicrobial effects. Journal of Emergency Medicine, 13: 581–585. Quinn JV, Ramotar K, Osmond MH (1996). Antimicrobial effects of a new tissue adhesive. Academic Emergency Medicine, 3: 536–537. Sabanathan S, Eng J, Richardson J (1993). The use of tissue adhesives in pulmonary resections. European Journal of Cardiothoracic Surgery, 7: 657–660. Scappaticci E, Ardissone F, Ruffini E, Baldi S, Mancuso M (1994). Postoperative bronchopleural fistula: endoscopic closure in 12 patients. Annals of Thoracic Surgery, 57: 119–122. Toriumi DM, Raslan WF, Friedman M, Tardy ME (1991). Variable histotoxicity of histoacryl when used in a subcutaneous site. Laryngoscope, 101: 339–343.
Received: 3 October 2000 Accepted after revision: 25 January 2001 Mr S. Sinha, Department of Orthopaedics, Monklands District General Hospital, Monkscourt Avenue, Airdrie ML6 0JS, UK. E-mail: [email protected] # 2001 The British Society for Surgery of the Hand doi: 10.1054/jhsb.2001.0572, available online at http://www.idealibrary.com on