ABSTRACT
Objectives
This study aims to evaluate the healing process and identify risk factors associated with delayed healing and outcomes.
Methods
1355 consecutive participants with nonsyndromic cleft palate, treated with the Sommerlad‐Furlow modified palatoplasty. Sixteen variables were recorded including sex, age, cleft type (Veau class), surgeons' qualification, antibiotics, relaxing incision (RI), postoperative upper respiratory tract infection (PURI), preoperative leukocyte count, preoperative hemoglobin (HGB), the cleft width, inter maxillary tuberosity width, the cleft ratio, operation duration, the initial time of poor healing wound observed after surgery, depth and location of the poor healing wound.
Results
In total, 1148 patients demonstrated normal healing (84.7%, 1148/1355), while 207 patients exhibited delayed wound healing issues (15.3%, 207/1355), among whom 131 healed within 3 months (9.7%, 131/1355; 63.3%, 131/207), 15 healed after 3 months and within 6 months (1.1%, 15/1355; 7.2%, 15/207), and fistula remained after 6 months in 61 patients (4.5%, 61/1355; 29.5%, 61/207). A total of 1294 (95.5%, 1294/1355) of the participants had healed palatal wounds after 6 months postoperatively. Surgeons' qualifications, PURI, the cleft width, cleft ratio, and operation duration were significantly different in the delayed healing group.
Conclusions
Preoperative measurement of the cleft ratio might help the cleft surgeons to predict the palate healing outcome. Surgeons' improved operation skills, shortened operation duration, and prevention of PURI were supposed to reduce the occurrence of poor wound healing. Moreover, focusing on delayed wound depth and location is critical for estimating the process and outcomes of delayed healing.
Level of Evidence
2
Keywords: cleft palate, delayed wound healing, palatoplasty, risk factors
1. Background
As one of the most serious long‐lasting complications after cleft palate repair, postoperative oronasal fistula was reported to occur, ranging from 0% to 60% [1, 2, 3], leading to impediments in speech and food reflux. A fistula is usually preceded by poor healing of the palatal wound, which might eventually heal even after several months or might end with fistula formation. During the poor wound healing processes, the patients' and/or their parents' perioperative fatigue and complaints were usually exacerbated due to the infants' crying and difficulty with feeding, insufficient intake, even dehydration, and concerns about unknown healing results. Effective prevention and early prediction of the poor wound healing process might help minimize anxiety and enhance the confidence of patients and their families.
Clinically improving the rate of wound healing is a great challenge for both soft and hard tissue repair. Predicting the likelihood of delayed healing outcome is an essential part of perioperative palatal wound care. Until now, it remained unknown what factors might cause delayed palatal wound healing [4]. Most of the previous studies focused on the risk factors of fistula formation [5], not the healing process [6]. Consult relevant literature reports; no studies have investigated the risk factors of delayed healing outcomes. The present study aims to investigate the healing process and outcomes of palatal wound healing following primary palatoplasty and to determine the risk factors influencing prognosis.
2. Methods
2.1. Patients
The study was approved by the Institutional Review Board of West China Stomatology Hospital of Sichuan University (WCHSIRB‐D‐2021‐261) and adheres to the principles outlined in the Declaration of Helsinki. In this study, 1355 participants with nonsyndromic cleft palate with/without lip from one single national clinical research center were consecutively analyzed during 2017–2023. All the participants were primarily repaired using Sommerlad‐Furlow modified (SF) palatoplasty [7, 8, 9, 10, 11, 12], which combines the advantages of the Sommerlad palatine velar muscle reconstruction and the Furlow reverse double Z soft palate plasty. Hard palate repair involved complete elevation of the mucoperiosteal flaps, separation of the oral and nasal layers, and release of the greater palatine neurovascular pedicles to facilitate flap mobilization. Based on the tension observed at the junction of the hard and soft palates. The bilateral relaxing incisions are made in the lateral areas of the soft palate/hard palate on the palatal side [13]. Patients were eligible for inclusion if they had a nonsyndromic cleft palate, with or without cleft lip; had no endocrine, cardiovascular, or immune system diseases; showed no signs of malnutrition; and followed proper postoperative feeding protocols in line with cleft palate care guidelines. Patients who were lost to follow‐up after surgery or at specific observation time points were excluded from the study.
Patients were followed by the same wound care specialist daily during the first 2 weeks after surgery, and subsequently once a month until complete wound healing or up to 6 months after the operation.
All patients received the same postoperative care guidance. Appropriate oral cleaning, a liquid diet, and a semi‐liquid diet were required during the first 2 weeks of observation. Infants who underwent cleft palate surgery were permitted to feed via a bottle.
2.2. Comparison Between the Normal Healing and the Delayed Healing
According to the palatal wound healing issues, two groups were noted: normal healing (palatal wound normally healed without any mucosal erosion, breakage, or fistula) and delayed healing (any mucosal erosion, breakage, or oronasal fistula occurred within 2 weeks after surgery), see Figures 1 and 2.
FIGURE 1.
Full‐thickness delayed healing wounds at different anatomical locations: (A) hard palate, (B) junction of the hard and soft palate, and (C) soft palate.
FIGURE 2.
Oral‐layer delayed healing wounds at different anatomical locations: (A) hard palate, (B) junction of the hard and soft palate, and (C) soft palate.
The collected data included: sex, cleft type (Veau class), surgeons' qualifications, antibiotics, relaxing incision (RI), postoperative upper respiratory tract infection (PURI), age, preoperative leukocyte count, preoperative hemoglobin (HGB), the cleft width, inter maxillary tuberosity width, the cleft ratio (the ratio between the width of the cleft/inter maxillary tuberosity width), and operation duration.
Veau's class was applied in cleft type classification [14, 15], including hard and soft cleft palate (Veau II), unilateral complete cleft palate (Veau III), and bilateral complete cleft palate (Veau IV). Patients with soft cleft palate (Veau I) and submucous cleft palate were excluded in the present study, for they were repaired using Furlow double‐opposing Z‐palatoplasty rather than Sommerlad‐Furlow modified palatoplasty in the research center.
A total of eight surgeons participated in the procedures, all of whom had completed standardized training in SF surgery. The surgical techniques and operative protocols were consistent across all cases. While the prophylactic antibiotics (Cefuroxime sodium 0.25 g administered every 8 h for a duration of 24 h) were administered before surgery, the prophylactic postoperative antibiotics were not routinely administered. Postoperative antibiotics were administered only to patients who developed an upper respiratory tract infection or had a laboratory‐confirmed bacterial infection, as determined by specialists.
Surgeons' qualifications were grouped into three categories according to their operation experience in palatoplasty: chief surgeons (more than 20 years of experience in palatoplasty), attending surgeons (5–20 years of experience), and residents (less than 5 years of experience).
Cleft width and inter‐maxillary tuberosity width were measured by the chief surgeon during the operation. Under general anesthesia, cleft width was measured intraoperatively during primary palatoplasty. Using a ruler and caliper—a method widely recognized in the literature [16]—the distance between the cleft edges was measured at the junction of the hard and soft palate [17, 18].
Upper respiratory tract infection within the first 2 weeks after surgery was recorded if patients presented with any of the following clinical manifestations [15]: fever (temperature > 37.5°C), cough, or nasal congestion.
2.3. Comparison Among the 3‐Month Delayed Healed, the 6‐Month Delayed Healed, and the Fistula
According to the duration of the delayed healing process, patients with poor healing wounds in the first 2 weeks after operation were further divided into three subgroups: 3‐month delayed healed (the palatal wound healed within 3 months after surgery, no fistula remained), 6‐month delayed healed (the palatal wound healed after 3 months and within 6 months after surgery, no fistula remained), and fistula group (palatal fistula remained after 6 months postoperatively); see Figure 1.
In addition to the aforementioned data, the onset time of poor wound healing was recorded. The location and depth of wounds exhibiting poor healing within the first 2 weeks after surgery were also documented. Fistula location was classified according to the Pittsburgh system [19]: (hard palate near the alveolus [HPA], hard palate [HP], junction of the hard and soft palate [JHSP], and soft palate [SP]). Uvular wounds, though uncommon, were classified under SP. Since only three patients had fistulas in the HPA region and the sample size was small, we combined these with HP fistulas for statistical analysis to minimize group size imbalance.
Oronasal perforations were defined as full‐thickness wounds, whereas all other cases of poor healing were classified as oral‐layer wounds.
2.4. Statistical Analysis
All statistical analyses were performed using SPSS version 25.0 (IBM Corp., Armonk, NY, USA). The Shapiro–Wilk test was used to assess the data distribution and the normality of all variables. The Kruskal‐Wallis test was used for comparisons across the three healing groups. Pearson's chi‐square test and Mann–Whitney rank sum test were used to determine the correlation between the risk factors and wound healing and percentage comparisons. To estimate associations between postoperative palatal wound healing and independent variables, binary logistic regression was used. p < 0.05 was considered significant in all tests.
3. Results
3.1. Demographic and Clinical Characteristics of 1355 Postoperative Patients With Different Kinds of Early Healing Status
Among the 1355 participants, 1148 (84.7%, 1148/1355) underwent normal healing, and 207 (15.3%, 207/1355) experienced delayed healing in the first two weeks after surgery (Tables 1, 2, 3). No differences were found in sex, age, and cleft type (Veau class) between the groups. Tables 1 and 2 further compared the categorical and the continuous variables separately between the two groups with different early postoperative healing status, normal healing, and delayed healing of the palatal wounds.
TABLE 1.
Demographic and clinical characteristics of 1355 patients with two kinds of postoperative palatal wound healing status (categorical variables).
| Variable | Total no. | Normal healing n (%) | Delayed healing n (%) | p a |
|---|---|---|---|---|
| Number of patients | 1355 | 1148 (84.7%) | 207 (15.3%) | |
| Sex | 0.255 | |||
| Female | 756 | 648 (85.7%) | 108 (14.3%) | |
| Male | 599 | 500 (83.5%) | 99 (16.5%) | |
| Veau class | 0.545 | |||
| II | 889 | 758 (85.3%) | 131 (14.7%) | |
| III | 282 | 233 (82.6%) | 49 (17.4%) | |
| IV | 184 | 157 (85.3%) | 27 (14.7%) | |
| Surgeon's qualification | < 0.001 | |||
| Chief | 192 | 170 (88.5%) | 22 (11.5%) | |
| Attending | 911 | 795 (87.3%) | 116 (12.7%) | |
| Resident | 252 | 183 (72.6%) | 69 (27.4%) | |
| Preoperative antibiotics | 0.513 | |||
| Given | 659 | 554 (84.1%) | 105 (15.9%) | |
| None | 696 | 594 (85.3%) | 102 (14.7%) | |
| Relaxing incision | 0.603 | |||
| Done | 206 | 177 (85.9%) | 29 (14.1%) | |
| None | 1149 | 971 (84.5%) | 178 (15.5%) | |
| Postoperative upper respiratory tract infection b | 0.001 | |||
| Yes | 240 | 189 (78.8%) | 51 (21.2%) | |
| No | 767 | 671 (87.5%) | 96 (12.5%) | |
Note: Pairwise comparisons for surgeon's qualification (Bonferroni‐adjusted): Chief versus Attending, p = 1.000; Chief vs. Resident, p < 0.001; attending versus resident, p < 0.001. Bold values indicates statistical significance p < 0.05.
Chi‐square test. Veau class II Soft and hard palate; III Soft and hard palate, unilateral; IV Soft and hard palate, bilateral (Patients with Veau class I were treated with Furlow palatoplasty which was excluded from this study).
348 cases lost to follow‐up.
TABLE 2.
Demographic and clinical characteristics of 1355 patients with two kinds of postoperative palatal wound healing status (continuous variables).
| Variables | Total n = 1355 | Normal healing n = 1148 | Delayed healing n = 207 | p a |
|---|---|---|---|---|
| Median (Q1–Q3) | ||||
| Age, year | 0.88 (0.67–1.80) | 0.88 (0.67–1.75) | 0.88 (0.67–1.86) | 0.675 |
| Preoperative leukocyte count, ×109/L | 9 (7.41–11.3) | 8.92 (7.39–11.29) | 9.44 (7.67–11.31) | 0.372 |
| Preoperative hemoglobin, g/L | 125.00 (117–132) | 125 (117–132) | 125 (116–133) | 0.936 |
| The width of the cleft, mm(A) | 11 (9–13) | 10 (9–13) | 12 (9–14) | 0.001 |
| Inter maxillary tuberosity width, mm (B) | 34 (30–38) | 34 (30.00–37.25) | 34 (30–38) | 0.448 |
| Cleft ratio (A/B) | 0.31 (0.26–0.38) | 0.31 (0.26–0.38) | 0.33 (0.29–0.41) | 0.001 |
| Operation duration, min | 75 (60–95) | 75 (60–90) | 85 (65–100) | < 0.001 |
Note: Bold values indicates statistical significance p < 0.05.
Mann–Whitney rank sum test.
TABLE 3.
Results of potential factors contributing to delayed healing using stepwise backward binary logistic regression.
| Predictor | OR | 95% CI | p a |
|---|---|---|---|
| Surgeon's qualification b | |||
| Resident(reference) | 1.00 | — | — |
| Chief | 0.46 | 0.24–0.88 | 0.018 |
| Attending | 0.44 | 0.30–0.65 | < 0.001 |
| Overall P | 0.001 | ||
| Postoperative upper respiratory tract infection | |||
| No | 1.00 | — | — |
| Yes | 1.88 | 1.27–2.80 | 0.002 |
| Operation duration, min | 1.01 | 1.00–1.02 | 0.008 |
Note: Bold values indicates statistical significance p < 0.05.
Binary logistic regression was performed using a backward stepwise method. The binary outcome was defined as normal healing = 0 and delayed healing = 1.
For the surgeon's qualification, resident was used as the reference category. For postoperative upper respiratory tract infection, No was used as the reference category. The p‐value for the surgeon's qualification (overall) represents the overall significance of this categorical variable in the model.
Between the two groups, patients who had PURTI (p = 0.001) and the surgeon's qualification (p < 0.001) showed a significant difference. Delayed wound healing was more likely to occur in patients operated on by residents than those treated by chief and attending surgeons. The cleft width, ratio, and the operation duration were also significantly different between the groups. No correlation was found among these risk factors between different healing groups, including prophylactic antibiotics, relaxing incision, preoperative leukocyte count, and preoperative hemoglobin.
It was noted that the surgeon's qualification was associated with early delayed wound healing (Table 3). Experienced surgeons as chiefs (OR = 0.380; p < 0.001) and attendings (OR = 0.420; p = 0.014) were protective, compared with residents. PURTI (OR = 1.771; p = 0.010), cleft ratio (OR = 10.971; p = 0.030), and the operation duration (OR = 1.009; p = 0.010) were the risk factors of early delayed wound healing.
3.2. Analysis of 207 Delayed Healing Patients With Three Different Healing Results
Based on the continuous clinical observation, poor palatal wounds were rarely observed after 14 days postoperatively for the first time (Tables 4, 5, 6). A total of 207 patients were found to have a delayed palatal healing course. Most of them healed within three consecutive months (63.3%, 131/207). Otherwise, the healing process might be prolonged to 6 months (7.2%, 15/207) or not completely heal, resulting in a persistent oronasal fistula after 6 months (29.5%, 61/207).
TABLE 4.
Demographic and clinical characteristics of delayed healing patients (categorical variables).
| Variable | Total No. n = 207 | Healing within 3 months, n = 131 (%) | Healing within 4–6 months, n = 15 (%) | 6 months unhealed, n = 61 (%) | p a |
|---|---|---|---|---|---|
| Sex | 0.614 | ||||
| Female | 108 | 70 (64.8%) | 9 (8.3%) | 29 (26.9%) | |
| Male | 99 | 61 (61.6%) | 6 (6.1%) | 32 (32.3%) | |
| Veau class | 0.091 | ||||
| II | 131 | 85 (64.9%) | 13 (9.9%) | 33 (25.2%) | |
| III | 49 | 32 (65.3%) | 2 (4.1%) | 15 (30.6%) | |
| IV | 27 | 14 (51.9%) | 0 (0%) | 13 (48.1%) | |
| Surgeon's qualification | 0.887 | ||||
| Chief | 22 | 12 (54.5%) | 2 (9.1%) | 8 (36.4%) | |
| Attending | 116 | 75 (64.7%) | 8 (6.9%) | 33 (28.4%) | |
| Resident | 69 | 44 (63.8%) | 5 (7.2%) | 20 (29.0%) | |
| Preoperative antibiotics | 0.614 | ||||
| Given | 105 | 66 (62.9%) | 6 (5.7%) | 33 (31.4%) | |
| None | 102 | 65 (63.7%) | 9 (8.8%) | 28 (27.5%) | |
| Relaxing incision | 0.290 | ||||
| Done | 29 | 16 (55.2%) | 4 (13.8%) | 9 (31.0%) | |
| None | 178 | 115 (64.6%) | 11 (6.2%) | 52 (29.2%) | |
| Postoperative upper respiratory tract infection b | 0.082 | ||||
| Yes | 51 | 29 (56.9%) | 7 (13.7%) | 15 (29.4%) | |
| No | 96 | 67 (69.8%) | 4 (4.2%) | 25 (26.0%) | |
| Wound location | |||||
| SP | 26 | 15 (57.7%) | 3 (11.5%) | 8 (30.8%) | 0.004 |
| JHSP | 74 | 57 (77.0%) | 6 (8.1%) | 11 (14.9%) | |
| HP | 106 | 58 (54.7%) | 6 (5.7%) | 42 (39.6%) | |
| Depth of wound | |||||
| Full layer | 132 | 74 (56.1%) | 13 (9.8%) | 45 (34.1%) | 0.011 |
| Oral layer | 75 | 57 (76.0%) | 2 (2.7%) | 16 (21.3%) | |
Note: Pairwise comparisons for wound location (Bonferroni‐adjusted): SP vs. JHSP, p = 0.446; SP vs. HP, P = 1.000; JHSP vs. HP, p = 0.005. Bold values indicates statistical significance p < 0.05.
Abbreviations: HP, hard palate; JHSP, junction of hard and soft palate; SP, soft palate.
Chi‐square test.
60 cases lost to follow‐up.
TABLE 5.
Demographic and clinical characteristics of delayed healing patients (continuous variables).
| Variable | Total n = 207 | Healing within 3 months n = 131 | Healing within 4–6 months n = 15 | 6 months unhealed n = 61 | p a |
|---|---|---|---|---|---|
| Median (Q1–Q3) | |||||
| Age, year | 0.88 (0.67–1.85) | 0.88 (0.67–1.8) | 0.83 (0.63–3.16) | 1 (0.72–2.98) | 0.390 |
| Preoperative leukocyte count, ×109/L | 9.52 (7.68–11.38) | 9.65 (7.71–11.84) | 9.65 (8.15–12.34) | 9.03 (7.38–10.31) | 0.257 |
| Preoperative hemoglobin, g/L | 125 (116–133) | 125 (117–133) | 129 (120.5–142.5) | 123.50 (114–131.5) | 0.646 |
| The width of the cleft, mm (A) | 11.5 (9–14) | 11 (9–14) | 11 (10.5–13) | 12 (10–14.5) | 0.131 |
| Inter maxillary tuberosity width, mm (B) | 34 (30–38) | 34 (29–38) | 33 (30–36) | 35 (31.50–39.5) | 0.567 |
| Cleft ratio (A/B) | 0.33 (0.29–0.41) | 0.32 (0.28–0.39) | 0.33 (0.29–0.4) | 0.36 (0.29–0.42) | 0.309 |
| Operation duration, min | 0.85 (0.65–101.25) | 80 (65–95) | 90 (82.5–117.5) | 95 (75–110) | 0.013 |
| Discovery time, day | 7 (5–9.25) | 7 (5–10) | 6 (4–7) | 7 (5–9) | 0.072 |
Note: Bold values indicates statistical significance p < 0.05.
Kruskal‐Wallis test.
TABLE 6.
Results of potential factors contributing to healing beyond 3 months using stepwise backward binary logistic regression.
| Predictor | OR | 95% CI | p |
|---|---|---|---|
| Wound location | |||
| Soft palate (reference) | 1.00 | — | — |
| Junction of the hard and soft palate | 0.49 | 0.18–1.37 | 0.174 |
| Hard palate | 1.18 | 0.45–3.06 | 0.739 |
| Overall p | 0.037 | ||
| Depth of wound | |||
| Oral layer(reference) | 1.00 | — | — |
| Full layer | 2.36 | 1.22–4.55 | 0.010 |
| Operation duration, min | 1.01 | 1.00–1.03 | 0.019 |
Note: Binary logistic regression was performed using a backward stepwise method. The binary outcome was defined as healing within 3 months = 0 and healing beyond 3 months = 1, with the latter including healing within 4–6 months and remaining unhealed at 6 months. The p‐value for wound location (overall) represents the overall significance of this categorical variable in the model. Bold values indicates statistical significance p < 0.05.
There were no significant differences among the three healing process groups, except for operation duration, wound depth, and wound location in the first 2 weeks. Longer operation duration was found in postponed healing groups (p = 0.013). The delayed wounds on the hard palate were more difficult to heal within 6 months and were more likely to develop into an oronasal fistula (39.6%, 42/106; 68.9%, 42/61). Postponed 6‐month healing (86.7%, 13/15) and residual oronasal fistula (73.8%, 45/61) were more common in the early full‐layer delayed healing wounds. Wound depth (OR = 4.335; p < 0.001) and location (OR = 1.370 in JHSP; OR = 3.693 in HP) were found to be related to the healing process in binary logistic regression analysis.
4. Discussion
The healing process of the wound goes through inflammatory, proliferative, and remodeling stages. During the early period, excessive inflammatory response might cause degeneration and necrosis of cells and tissues, an increase in vascular permeability, including a large number of neutrophils and protein‐rich fluid leaking out of the blood vessels, resulting in tissue edema, suppurative dissolution, and delaying wound healing [20]. In this study, the rate of early delayed healing wounds among the 1355 patients was 15.3% (207/1355), which is higher than the wound‐healing complications reported in a previous report (3.4%) [21]. However, the patients in that study were younger than 2 years old, and were not as frequently followed and recorded as in the present study. Early oronasal fistula formation and potential perioperative variables such as cleft width, surgeons' qualifications, relaxing incisions, or surgical technique were not evaluated either.
Although the healing process varied, more than half of the wounds healed within 3 months (63.3%, 131/207), and most of the early delayed healing wounds (70.5%, 146/207) would heal eventually within the first 6 months. The final palatal fistula rate after 6 months was 4.5% (61/1355), similar to previous studies [1, 2, 3]. Even those full‐layer oronasal perforations in the early postoperative stage, a considerable amount of which could still eventually heal within 6 months (65.9%, 87/132). The available evidence might help inspire confidence in the strength of recovery if unfavorable healing occurs early after surgery.
It was noted that sex, age, Veau type, relaxing incision, prophylactic antibiotics, preoperative leukocyte count, and preoperative hemoglobin were not predictors for early delayed wound healing, and subsequently not related to the healing process, which was consistent with previous findings [22, 23]. In this study, palatal relaxing incisions were performed in only 15.2% (206/1355) of the patients, while the final fistula ratio (4.5%) was not apparently increased. It was also noticed that the relaxing incision was not significantly different between the different early healing status groups and the latter healing process groups. It was indicated that making relaxing incisions during palatoplasty might not reduce early wound healing impairment, shorten the healing process, nor decrease fistula residuals as was supposed. Besides, delayed healing could hardly be prevented by prophylactic antibiotics nor predicted through variable preoperative blood routine test results, for neither were noted to be associated with both early delayed healing and different postoperative healing processes.
Surgeons' qualifications have been reported to be an effective factor in wound healing [24], which was consistent with current findings. Palatoplasty requires proficient surgical skills in dissection and suturing. Inadequate experience of residents may cause a higher incidence of delayed wound healing, though the process and the final prognosis were barely related to surgeons' qualifications once the delayed healing occurred.
Operation duration was previously highlighted as an independent risk factor for SSI (surgical site infection). Patients with extended surgical duration were approximately twice as likely to develop SSI, and the average surgical duration was approximately 30 min longer in patients with SSI compared to patients without SSI [25]. Longer operation duration might be associated with inadequate experience and unskilled operation, which may also mean increased fatigue and more technical errors for the surgeon [26, 27, 28]. A significant difference was observed not only between the normal and delayed‐healing groups (p < 0.001), but also among groups with different delayed‐healing processes (p = 0.013) in the present study.
In this study, the cleft width and cleft ratio were found to be significantly different in the early delayed healing group (p = 0.001), although there was no statistical significance in the Veau class and implementation of palatal relaxing incision between groups. Similarly, they were not significantly different across the healing process groups. Wider cleft width and a higher cleft ratio led to a lack of tissue horizontally, resulting in greater tension during suturing. A previous study had confirmed that postoperative recovery was negatively correlated with the relative change of the width of the cleft/inter‐maxillary tuberosity width; that is, those with a small relative change were more likely to recover [29]. Relaxing incisions are generally considered to help reduce wound tension during palatal closure [17, 30] and may also be effective in minimizing cleft relapse or postoperative fistula formation. However, the current results did not support the latter hypothesis.
The influence of PURTI on wound healing has yet to be reported. It was noted that infants with PURTI were more likely to suffer from early delayed wound healing, and the healing duration tended to be prolonged to over 3 months, lasting 6 months, while no significant differences were found in presurgical leukocyte count, presurgical hemoglobin, and prophylactic antibiotics usage between groups. The discomfort caused by PURTI might affect the infant's immune competence, and the baby's crying might reopen the wounds, making the recovery harder [31].
Surgeons might predict the process of poor palatal wound healing based on the depth and location of the early poor healing wound. Patients with early oronasal perforations of the hard palate had the highest rate of palatal fistula. It seemed that delayed healing of the wound, even the early oronasal fistula in other locations, had a higher potential to be reversible and treatable nonoperatively. In terms of wound depth, it was concluded that deeper wounds had a greater possibility of fistula formation: 34.1% of the full‐layer wounds (45/132) failed to heal and maintained a fistula. In the 6‐month healed group, 86.7% were those with a full‐layer delayed wound, which indicated that longer processes were necessary for early oronasal perforations to heal. Moreover, some early oral layer delayed wounds might continuously deteriorate into a permanent oronasal fistula after the first 2 weeks. Frequent follow‐up, close observation, and cautious caring were strongly recommended, though the discovery time of the delayed wound was not related to the following healing process and the final results.
Regarding long‐term outcomes, while this study focused on wound healing, speech results are a critical measure of success after palatoplasty. The surgical technique used, the Sommerlad‐Furlow modified palatoplasty, is designed to improve velopharyngeal function, which is essential for normal speech. The low final fistula rate of 4.5% observed in our cohort is a positive indicator for good speech outcomes, as oronasal fistulas are a major cause of speech impediments such as hypernasal resonance and compensatory articulation errors. A detailed analysis of speech results remains an important area for future investigation. Future studies should correlate these early healing patterns with long‐term speech development to provide a more comprehensive evaluation of the surgical outcomes.
This observational study had several limitations, including its non‐randomized design, the absence of speech outcome measures, and the lack of adjustment for multiple comparisons. The sizes of the wounds were noticed to be related to the healing process and results during the follow‐up observations, while the precise size of the wound needs further 3‐D intraoral measurements; the size was not discussed in the current study. These concerns will be addressed in future studies.
5. Conclusions
Preoperative measurement of the cleft ratio might help the cleft surgeons to predict the palate healing outcome. Surgeons' improved operation skills, shortened operation duration, and prevention of PURI were supposed to reduce the occurrence of poor wound healing. Moreover, focus on delayed wound depth and location is critical in estimating the process and outcomes of delayed healing.
Funding
Research and Development Program, West China Hospital of Stomatology, Sichuan University (LCYJ‐HL‐202306).
Ethics Statement
The study was approved by the Institutional Review Board of West China Stomatology Hospital of Sichuan University (WCHSIRB‐D‐2021‐261) and adheres to the principles outlined in the Declaration of Helsinki.
Consent
The authors have nothing to report.
Conflicts of Interest
The authors declare no conflicts of interest.
Supporting information
Figure S1: Palatal fistulas 3–6 months postoperatively at different anatomical locations: (A) hard palate, (B) junction of the hard and soft palate, and (C) soft palate.
Acknowledgments
The authors have nothing to report.
Data Availability Statement
Research data are not shared.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Figure S1: Palatal fistulas 3–6 months postoperatively at different anatomical locations: (A) hard palate, (B) junction of the hard and soft palate, and (C) soft palate.
Data Availability Statement
Research data are not shared.