Local Wound Care for Primary Cleft Lip Repair: Treatment and Outcomes With use of Topical Hydrogen Peroxide

Objectives. This study highlights and validates a peroxide-based wound healing strategy for treatment of surgically closed facial wounds in a pediatric population. The authors identified pediatric patients undergoing primary cleft lip repair as a specific population to evaluate the outcomes of such a protocol. Through analysis of defined outcome measures, a reliable and reproducible protocol for postoperative wound care following primary cleft lip repair with favorable results is described. Methods. This retrospective study analyzes wound healing outcomes in pediatric patients undergoing primary cleft lip repair from 2006 to 2011 at a tertiary academic center. The wound healing protocol was used in both primary unilateral and bilateral repairs. One hundred forty-six patients between the ages of 0 and 4 years underwent primary cleft lip repair and cleft rhinoplasty by a single, fellowship-trained craniofacial surgeon. Postoperatively, wounds were treated with half-strength hydrogen peroxide and bacitracin, as well as scar massage. Incisional dehiscence, hypertrophic scar formation, discoloration, infection, and reoperation were studied. Outcomes were evaluated in light of parent compliance, demographics, preoperative nasoalveolar molding (PNAM), and diagnosis. Results. The authors identified 146 patients for inclusion in this study. There was no wound or incisional dehiscence. One hundred twenty-four patients demonstrated favorable cosmetic outcome. Only 3 (2%) of patients who developed suboptimal outcomes underwent secondary surgical revision (> 1 year after surgery). Demographic differences were not statistically significant, and PNAM treatment did not influence outcomes. Conclusion. These data validate the use of half-strength hydrogen peroxide and bacitracin as part of a wound healing strategy in pediatric incisional wounds. The use of hydrogen peroxide produced comparable outcomes to previously published studies utilizing other wound healing strategies and, therefore, these study findings support the further use of this regimen for this particular population.

Cleft lip and palate is a congenital condition requiring a coordinated multidisciplinary team approach in which surgeons typically manage postoperative wound care. Changes in health care have led to a reduction in hospital stay, and wound care now extends under the auspices of the primary care provider. Data are lacking on the role of hydrogen peroxide in surgical incision care, particularly in the pediatric literature. This lack of information has caused hesitation among practitioners to use hydrogen peroxide for incision care, lest its use cause the incisions and wounds to fall apart and have ill-appearing scars.^1,6 In response to these concerns, the authors aimed to evaluate the outcomes of their hydrogen peroxide based wound healing strategy in a specific pediatric population: patients undergoing primary cleft lip repair.

Impeccable surgical closure is essential to ensure positive postoperative outcomes following primary cleft lip repair and cleft rhinoplasty. The importance of postoperative wound care, however, should not be overlooked. Improper care can result in poor cosmetic and functional outcomes, despite pristine operative technique. In the immediate postoperative period, the goals of wound care include preventing infection and removing obstacles to epithelialization. While proper postoperative wound management after cleft lip closure is recognized as fundamental to repair, few studies have focused on defining optimal wound management.

Wound healing is a complex process involving the integration of 3 distinct overlapping phases—inflammation, proliferation, and remodeling.¹ The initial inflammatory phase is essential to wound closure; however, if this phase is significantly accelerated or enhanced, wound healing can be impaired.

Initial reports advocated for postoperative use of hydrogen peroxide to cleanse wounds and remove debris.² Antiseptics have long been used to prevent and treat wound infections, as these agents destroy and inhibit the growth of microorganisms in living tissue. Commonly used antiseptic agents cleanse intact skin and are used to prep patients preoperatively and treat skin prior to intramuscular injections or venipuncture.^3,4 However, the role of antiseptics such as hydrogen peroxide as prophylactic anti-infective agents for postoperative wound care remains to be determined.

The role of hydrogen peroxide in wound and incision care has been controversial. Hydrogen peroxide is a strong oxidizing agent that produces free radicals, which have been proposed to both promote wound closure and prevent bacterial growth.³ In vitro studies have shown that hydrogen peroxide has the greatest activity against gram-positive bacteria.⁵

Recent studies speak to the positive biochemical effects of hydrogen peroxide on acute wounds and dispel arguments that this chemical causes tissue damage. Scratch wound healing and co-culture studies show that reactive oxygen species produced by hydrogen peroxide may enhance keratinocyte proliferation, migration, and re-epithelialization,^6,7 and keratinocytes are further protected from the possible toxic effects of these free radicals.⁶ A letter to Nature in 2009 speaks to the potential benefits of hydrogen peroxide, as the authors describe how endogenously produced peroxide in acutely injured tissue signals leukocyte recognition and trafficking to stimulate repair.⁸ Other in vivo incisional wound healing studies comparing 1% hydrogen peroxide treatment to positive controls (petroleum) and negative controls demonstrated decreased bacterial colonization and accelerated wound healing in the hydrogen peroxide treatment group.⁹ These studies argue that hydrogen peroxide, when used in clinically relevant quantities, is unlikely to cause damage and may, in fact, demonstrate positive therapeutic properties.

The aforementioned literature supports the use of hydrogen peroxide on incisional wound care based on the biochemical properties of peroxide, but there is a contradictory body of literature arguing its deleterious effects. Loo and Halliwell⁶ demonstrated enhanced keratinocyte migration with the use of hydrogen peroxide, but other studies in fibroblasts have shown dose-dependent diminished migration, resulting in impaired wound healing and scar formation.^10,11 Although compelling, the results of these studies cannot be extrapolated to closed incision/repair, as they were performed in open wounds, and 1 study was performed in a scarless fetal wound healing model.^10-13 Since the authors’ interest for this study is in sterile, surgically closed incisional pediatric wounds, these results could not be extrapolated to apply to surgically closed cleft lip wounds.

Patient population. The authors retrospectively reviewed the cases of 146 patients who underwent unilateral or bilateral primary cleft lip repair from 2006-2011 (Table 1). All patients were between the ages of 0 and 4 years old. These patients underwent primary cleft lip repair and cleft rhinoplasty. In the review of these outcomes, the authors investigated all outcomes in the perioperative period related to the surgery itself or postoperative wound care. Moreover, the authors investigated all interventions performed as a result of these postoperative events. Patients’ race, ethnicity, gender, and age at surgery were taken into account. In general, the authors’ clinical protocol for these patients included the removal of skin sutures at the end of 1 week, and instructions were given to perform scar massage starting 2 weeks postoperatively. Compliance with these measures was also used in outcome analysis, as well as need for additional cleft lip revision. All protocols were reviewed and approved by the Oregon Health and Science Institutional Review Board. 

Surgical method. Patients with unilateral cleft lip/palate underwent extended Mohler type repair. Patients with bilateral cleft lip/palate underwent Mulliken-Cutting type repair. All patients received preoperative intravenous antibiotics (cefazolin sodium, unless contraindicated) and 1 dose of IV dexamethosone (1 mg/kg).

Absorbable sutures were used for all layers of closure. A 6-0 plain gut suture was used for the final skin closure. Presurgical nasoalveolar molding (PNAM) was introduced to the authors’ clinic in 2008. Prior to PNAM, all patients with complete cleft lips underwent presurgical orthopedic therapy with lip taping alone.

Postoperative care. Patients were admitted for overnight observation and received IV antibiotics for 24 hours. Immediately postoperatively and for the first week after surgery, parents were instructed to use half-strength hydrogen peroxide followed by bacitracin 5 times daily to remove any dry blood or scabs. Elbow splints were used to prevent accidental trauma of the incision by the infant and were used for 3 weeks postoperatively. At the end of 1 week, the plain gut sutures were removed via the frequent cleaning, and no further hydrogen peroxide solution was needed. After 2 weeks, parents were instructed to begin gentle pressure to the incision. At 3 weeks postoperatively the parents were told to vigorously massage the wound in a downward and circular motion several times a day. Also at 3 weeks, the nasal stents were removed.

Statistical analysis. Basic statistical analysis was conducted using Prism (Graphpad Software Inc, San Diego, CA). The statistical difference among 2 or more groups was determined by one-way ANOVA. Statistical significant was set at P < 0.05.

Patient demographics. Demographic data and medical history was collected for all patients, including information regarding gender, ethnicity, race, diagnosis, PNAM usage, and age at surgery. Of the 146 patients who underwent primary cleft lip repair, 103 patients were male and 43 patients were female (Table 1). Patients were of non-Hispanic (122 patients) and Hispanic (20 patients) origins. A total of 121 patients were white, 2 were black, 7 were Asian and Pacific Islander, and 13 were multiracial. The ethnicity and race of 4 patients were unknown and could not be identified due to incomplete records and loss to follow-up. Inclusion criteria were patients with bilateral or unilateral cleft lip and palate or cleft lip alone. Forty-one patients underwent PNAM treatment, while 105 patients did not. Patients were between the ages of 2 and 17 months old at the time of surgery. The average age was 152 days, and the median age was 131 days old. The average length of follow-up was 454 days, with median follow-up of 276 days, ranging from 6 days to 1,978 days. 

Treatment outcomes. The authors defined their success rate by absence of incisional dehiscence, hypertrophic scar formation, or discoloration at the surgical site. Dehiscence did not occur in any of the lip repairs. Of the 146 patients who underwent primary cleft lip repair, 124 patients demonstrated complete wound closure with favorable cosmetic outcomes (Figure 1). In the immediate postoperative setting (< 1 year post-op), there were 22 patients (15%) who had suboptimal outcomes (ie, hypertrophic scar [16], infection [5], and hyperpigmentation [1]). Of the patients who developed suboptimal findings, 15 were male and 7 were female (Table 2). While more males developed complications compared to females, these findings likely reflect the composition of the patient population rather than innate gender differences, as no statistically significant difference between gender and the development of complications was observed. The formation of hypertrophic scar, discoloration, or infection was independent of gender, ethnicity, and race (P ≥ 0.05). While the precise cause of hypertrophic scar formation is unknown, patients with these outcomes were also treated for postoperative infection, poor massage compliance by parents, and failure to use elbow restraints (Table 2), all of which could have contributed to delayed healing after cleft lip repair. 

Of the patients who developed hypertrophic scars, 12 were diagnosed with unilateral cleft lip, whereas 5 patients underwent bilateral repairs. Nine patients were diagnosed with incomplete cleft lip, whereas 8 patients underwent complete cleft lip repairs (Table 2). Eight patients were admitted due to poor massage compliance and 4 patients were noncompliant with elbow splints. Of these patients, 1 developed discoloration, 8 developed hypertrophic scar, 2 experienced postoperative infection requiring antibiotics, 1 was treated with tacrolimus, 1 was given a steroid injection, and 3 underwent secondary surgical revision.

Only 3 (2%) patients who developed suboptimal outcomes underwent secondary surgical revision (> 1 year after surgery). One of the 3 patients was diagnosed with complete cleft lip, while the other 2 patients were diagnosed with incomplete cleft lip. None of the 3 patients underwent PNAM.

Preoperative nasoalveolar molding treatment prior to surgery. Out of 146 patients, 41 patients underwent PNAM treatment prior to primary cleft lip repair and cleft rhinoplasty. Of the 41 patients who used PNAM, 5 patients (12%) had suboptimal outcomes, including treatment for presumed postoperative wound infection or scar hyperpigmentation or hypertrophy. Of the 105 patients without PNAM devices, 17 patients (16%) developed complications. The suboptimal outcomes in patients who underwent PNAM treatment were statistically not significantly different than in those patients who did not undergo PNAM treatment (P ≥ 0.05). None of the patients who were treated with PNAM underwent secondary surgical revision. 

Treatment of postoperative outcomes. For the 22 patients who developed suboptimal outcomes (see example, Figure 2), 7 patients did not require additional treatment, 9 patients received antibiotics, 2 patients were prescribed topical tacrolimus ointment for treatment of scar hypertrophy or hyperpigmentation, 3 patients underwent cleft lip revisional surgery (see example, Figure 3), and 1 patient was treated with corticosteroids (Table 2). Of the patients who received antibiotic treatment, 2 patients received tacrolimus ointment following a course of antibiotics, while 1 patient received scar injections with corticosteroids (ie, triamcinolone acetonide injectable suspension) after antibiotic treatment. Neither of the patients treated with tacrolimus required secondary surgical revision.  

Institutional Review Board approval was obtained but no consent was required as this his was a retrospective study; consent was obtained for use of the case photos.

Postoperative wound care ensures proper wound healing without infection, hypertrophic scar formation, or discoloration around the surgical site. While the importance of keeping the wound clear of infectious agents and blood clots is uniformly recognized, the precise method remains controversial. In the cleft lip and cleft palate literature, patients have been provided with saline and antibiotics to cleanse and prevent infection around the surgical site, while other patients have been encouraged to use petroleum ointment to prevent blood clots around the sutures.^14,15 Trier¹⁵ avoided the use of hydrogen peroxide due to the possibility of skin irritation and premature removal of sutures. However, previous studies have demonstrated the usefulness of hydrogen peroxide to cleanse wounds and remove debris and potential pathogens.¹⁵

The present study investigated the use of half-strength hydrogen peroxide followed by bacitracin ointment for postoperative wound care to prevent suboptimal outcomes such as postoperative infection, inflammation, and pathologic scar formation. The use of postoperative half-strength hydrogen peroxide on surgical incisions after primary cleft lip repair resulted in consistently positive postoperative outcomes with low infection and secondary surgical revision rates. Of the patients who presented with suboptimal outcomes, compliance with postoperative wound care with hydrogen peroxide application, massage, or accidental injury to surgical site appear to have contributed to these results. Of the patients who developed suboptimal outcomes, 43% were noncompliant with postoperative wound care.

The importance of compliance with postoperative wound care has been well documented in the literature, and others, such as Noordhoff¹⁶ have also encouraged gentle massage after surgery to breakdown potential scar tissue. Although unappealing scar appearance can often be attributed to poor patient or parental compliance, hypertrophic scars are also known to form in predisposed individuals as a result of the body’s intrinsic tendency to overproduce scar tissue following an insult to the integrity of the tissue due to the surgical procedure or trauma. During normal wound healing, the body produces de novo collagen fibers at a rate that balances the breakdown of mature collagen fibers.¹⁷ Hypertrophic scars typically arise due to the excess production of collagen by fibroblast, resulting in a raised and red or pink colored scar that does not exceed the margins of the original wound.¹⁸ The outcomes in these predisposed individuals are consistent with data published in previous studies,¹⁸ as the appearance of hypertrophic scars markedly improved over time in 5 of the 9 patients who showed this postoperative result.

Presurgical orthopedics with lip taping alone or PNAM devices have demonstrated success in narrowing wide clefts and limiting wound tension, resulting in diminished postoperative scar formation.^19-21 Consistent with previous studies, the current study suggests the development of scarring is independent of PNAM usage and is proportional to the number of patients who underwent PNAM. None of the patients in this study who underwent PNAM required secondary surgical revision.

This study focused on the use of half-strength hydrogen peroxide in the treatment of postoperative incisional wounds following primary cleft lip and primary cleft rhinoplasty. All of the wounds remained intact. Although these data are limited to a fairly narrow patient population undergoing a very specific operation, the results are particularly important given the direct communication of the incisions with the oral and nasal cavities. It is well known that scars are the inevitable consequence of physiologic wound healing, and a tremendous amount of effort has been put into ameliorating this phenomenon, albeit without success. Furthermore, as the child grows to adulthood, poor cosmetic outcomes from scars incurred when very young can result in devastating psychological consequences. Therefore, the authors believe this study to be interesting not only from an academic point of view but also in the adherence to and development of treatment algorithms to ensure the best possible outcomes. Patients undergo primary cleft lip repair to ensure the development of proper oral function and speech; however, cosmetic outcomes are also essential to developing confidence through development. As such, the authors believe that detailed attention at every opportunity in the care of these patients is essential, and clear, detailed instructions for the parents are important to ensure compliance. Future studies comparing the efficiency of hydrogen peroxide to saline may further define the optimal management of these challenging pediatric postoperative wounds.

The data presented in this comprehensive review validates the use of half-strength hydrogen peroxide and bacitracin as part of a well-developed wound healing strategy in this pediatric surgical population. The use of hydrogen peroxide in this study produced comparable outcomes to previously published studies utilizing other cleansing mechanisms^22,23 and with a high-rate of favorable cosmetic appearance.

Affiliations: Tulane University School of Medicine, New Orleans, LA; and Oregon Health & Science University, Portland, OR

Correspondence:
Anna A. Kuang, MD
Chief, Pediatric Plastic and Craniofacial Surgery, and Associate Professor, Division of Pediatric Surgery, Department of Surgery, Pediatrics and Pediatric Dentistry
Oregon Health & Science University
3181 SW Sam Jackson Park Road, CDW 229
Portland, OR 97239
kuanga@ohsu.edu

Disclosure: The authors disclose no financial or other conflicts of interest.