Vacuum-assisted closure (VAC) Freedom Therapy Pump Unit (Kinetic Concepts Industries). A, Application on the fibula donor site. B, Split-thickness skin graft healing well on removal of dressing. C, Late mild cellulitis surrounding healed skin graft 4 weeks postoperatively.
Ho MWS, Rogers SN, Brown JS, Bekiroglu F, Shaw RJ. Prospective Evaluation of a Negative Pressure Dressing System in the Management of the Fibula Free Flap Donor SiteA Comparative Analysis. JAMA Otolaryngol Head Neck Surg. 2013;139(10):1048-1053. doi:10.1001/jamaoto.2013.4544
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The fibula free flap donor site has been associated with short-term donor site morbidity, most commonly delayed healing.
To evaluate the effectiveness of a negative pressure dressing (NPD) system in the management of fibula free flap donor sites that required skin graft closure.
Cohort study comparing a prospective cohort whose donor sites were managed with the NPD system from June 2009 through March 2012 with a retrospective cohort whose donor sites were managed with a conventional pressure (bolster) dressing (CPD) from August 2006 through May 2009.
Tertiary regional head and neck reconstructive and maxillofacial surgery unit.
All patients who had a composite fibula free flap for maxillofacial reconstructive surgery and required donor site closure with split-thickness skin grafts from August 2006 through March 2012.
Negative pressure dressing used to manage the skin-grafted fibula donor site.
Main Outcomes and Measures
Primary: time until complete healing of the fibula donor site. Secondary: skin graft take rate, infection rate, returns to operating theater for donor site problems, delayed hospital discharge due to donor site problems, and community intervention required for donor site dressing.
All healing outcome measures were similar for the 21 patients in the NPD group and the 19 patients in the CPD group, with no statistically significant difference. Two patients in the CPD group required surgical debridement of the fibula donor site, compared with none in the NPD group (P = .22). The NPD group had a higher skin graft take success rate (15 [71%] vs 11 [58%]; P = .51) and required less nursing intervention for donor site dressings (8 [38%] vs 9 [47%]; P = .75) but had a higher wound infection rate (6 [29%] vs 2 [11%]; P = .24).
Conclusions and Relevance
Our findings would, at best, suggest that NPD may decrease the rate of return to the operating theater for donor site problems. The fibula donor site healing remains problematic, and our results suggest that routine use of the NPD system in the management of the fibula free flap donor site is not justified from a health economic perspective.
The osteocutaneous fibula free flap is an essential option in the reconstruction of composite defects of the facial skeleton because of its relative ease of harvest and the long length of bone available, which allow reconstruction of subtotal mandibular defects, multiple osteotomies to facilitate contouring, or double barreling. Additional advantages of this flap include its long pedicle length (hence useful in surgical salvage where vascular access is a challenge) and large vessel caliber, allowance for simultaneous ablative surgery and flap harvest, and the availability of skin paddle(s) depending on perforator anatomy. This however can be associated with short-term donor site morbidity, the commonest of which is delayed healing1; the rare but important compartment syndrome2,3; and long-term morbidities including neurosensory deficit, chronic pain, gait abnormality, ankle instability, reduced strength, and toe deformities.4- 10 Outcomes of postoperative morbidity of the fibula free flap donor site from our unit have been published previously, showing results comparable to those of the vascularized iliac crest.1
One persistent problem and a challenge in our surgical practice was the delayed healing of the fibula donor site. When a skin paddle component is harvested with the fibula, there remains some controversy as to whether the donor site should be primarily closed or skin grafted, each position having its own proponents.4,5 It has been our practice to apply a split-thickness skin graft (STSG) to the cutaneous defect when it was not possible to close the wound primarily without tension because our experience of primary closure under tension was associated with the occurrence of wound dehiscence and ischemic sequelae, ranging from localized muscle and/or tendon necrosis (Figure 1) to compartment syndrome. A recent audit of our clinical practice revealed that in approximately 50% of fibula free flap cases, there was delayed donor site healing due to 1 or more of the following: wound dehiscence, tendon exposure, infection, and skin graft failure (combined cohort in which donor sites were either closed primarily or skin grafted; M. W. S. H., S. N. R., and R. J. S., unpublished data, 2009).
The application of a negative pressure dressing (NPD) system seemed to be an attractive option in the management of STSGs for fibula donor sites as it became more widely used in wound management. This was supported by seemingly improved outcomes when its use was compared with that of conventional pressure (bolster) dressings11,12 in the management of the radial forearm donor site.13,14 We therefore conducted a prospective-retrospective comparative assessment of the use of the NPD system in the management of the fibula free flap donor site to compare healing outcomes with those of the conventional pressure dressing (CPD).
Since 2008, it has been our standard practice to assess the suitability of the fibula donor site with preoperative lower limb angiography (primarily magnetic resonance angiography). Limb selection was based on recommendation reported by the interventional radiologist; features more adverse than mild atherosclerosis would contraindicate the harvest of a fibula free flap. In principle, the fibula free flap is also contraindicated in patients with clinical evidence of venous insufficiency of the lower limbs. The fibula free flaps were all harvested via the lateral approach (without application of a tourniquet), and the skin paddle was designed around cutaneous perforators identified by means of handheld Doppler assessment at the start of the procedure (usually located in the vicinity of the junction between the middle and distal thirds of the fibula bone). At the proximal and distal extent of the fibula, 5 to 7 cm of bone was preserved for protection of the superficial peroneal nerve and to maintain the integrity of the ankle joint. A cuff of flexor hallucis longus and soleus muscles was usually harvested with the flap to protect the cutaneous perforators to the skin paddle. The cutaneous defect was reconstructed with an STSG, and the rest of the wound was primarily closed. In the NPD group, following inset of the STSG, a flexible polyester mesh impregnated with hydrocolloid and petroleum jelly particles (Urgotul; Urgo Medical) was applied directly over the STSG, followed by application of the NPD, vacuum-assisted closure (VAC) Freedom Therapy Pump Unit (Kinetic Concepts Industries), foam, and occlusive suction dressing (Figure 2 and Figure 3). A separate vacuum drain was also placed to drain the deeper compartments of the donor site and removed when the drainage rate was less than 30 mL per 24 hours. The NPD was set on 125 mm Hg continuous suction, moderate intensity, and left for 5 days. After 5 days, the STSG was dressed with a nonadherent dressing supported by crepe bandage. Patients were usually mobilized as early as tolerated, usually from the third postoperative day, partially weight bearing to reduce the risk of venous thromboembolism. In the CPD group, instead of the NPD, a leno-weave fabric impregnated with soft white paraffin (Jelonet; Smith & Nephew) was applied directly over the STSG, and a tie-over bolster dressing constructed with proflavin-impregnated absorbent cotton, wrapped in Jelonet, was secured with 2/0 silk sutures. This was further protected with a supportive wool and crepe bandage and left undisturbed for 10 days. This and the operating surgeons were the only differences in the management of the fibula donor sites between the CPD and NPD groups.
Two groups of patients who had osteocutaneous fibula free flap reconstruction of composite mandibular or maxillary ablative defects were included in this study: a prospective cohort and a retrospective cohort. The prospective cohort (NPD group) included a consecutive series of patients who required STSG for fibula donor site repair in whom the NPD was used. The retrospective cohort (CPD group) were identified from the electronic Regional Maxillofacial Unit computerized database and consisted of consecutive patients who had CPD to secure the STSG. This study was registered as a service evaluation exercise; thus, ethical approval by the institutional review board was not required. As there was no change to standard practice or level of care, it was not necessary to obtain informed consent.
Data were collected for the following parameters: patient demographic details, diagnosis, comorbidity (American Society of Anesthesiologists grade, Adult Comorbidity Evaluation 27 score, and history of diabetes mellitus), size of fibula donor site cutaneous defect, skin graft take (assessed at postoperative weeks 4-6 in the outpatient dressing clinic), wound infection, return to operating theater for donor site problem, delayed discharge from hospital due to donor site problem, need for district or dressing clinic nurse’s attention to donor sites following hospital discharge, and time taken for complete healing of donor sites. In the NPD group, data were prospectively entered into a data sheet that followed the patient journey from hospital admission to discharge. Additional follow-up information was collected in a specific data sheet in the Regional Maxillofacial Dressing clinic. Retrospective data were collected from medical records (case notes and Regional Maxillofacial Dressing clinic diary where each patient visit to the clinic was recorded detailing wound status, treatment administered, and future follow-up with action plan for the district nursing team) of patients in the CPD group. The point at which patients were discharged from the dressing clinic was taken as the date when the donor site had healed completely, the defined end point of the present study.
Data from the NPD and CPD groups were compared with SPSS software, version 18.0 (SPSS Inc). The Mann-Whitney test was used for comparison of median values for age, length of stay, time for complete donor site healing, and comorbidity scores. The Fisher exact test was used to compare sex, diabetic status, indication for reconstructive surgery, grade of operating physician, infection rate, wound healing problems, need for district nurse intervention, and return to operating theater for donor site problems. P values were reported (P < .05 was considered statistically significant).
The NPD group had 21 patients (June 2009 through March 2012), and the CPD group, 19 patients immediately preceding the prospective NPD cohort (August 2006 through May 2009). The summarized comparison of treatment and donor site healing details between these 2 groups of patients is listed in Table 1. There was no significant difference in age, sex, and comorbidities between the 2 groups. The median length of hospital stay and time to complete wound healing were also similar in both groups. The operating physician who performed the flap harvest was more often a consultant in the NPD group (52%), compared with the CPD group (21%). The NPD group had a higher skin graft take success rate and required less intervention by district nurses for donor site dressings but was associated with a higher wound infection rate, compared with the CPD group. Two patients in the CPD group required return to the operating theater for surgical attention to the fibula donor site (1 in a patient with poor diabetic control for excision of a segment of nonvascularized peroneus longus muscle and another for excision, by a vascular surgeon, of a nonhealing scar that was nonresponsive to wound dressings and stocking therapy); this was not observed in the NPD group. The differences observed between the 2 groups were not statistically significant.
The flap survival rate in this study was 98% (39 of 40), with 1 late flap failure in a patient with mandibular reconstruction for osteoradionecrosis (vessel depleted neck and required vascular access to the internal thoracic vessels via a median sternotomy).
To our knowledge, the present study is the first assessment of NPD in the management of the fibula donor site to be published. This study has shown that, in the management of the fibula donor site, there was no difference in the healing outcomes between NPD and CPD groups of patients. The observation of more consultant involvement in the NPD group, compared with the CPD group, was a reflection of the level of experience of the surgical trainees rotating through the Head and Neck Reconstructive team during the study period (the cohort of senior trainees during the CPD data collection period were replaced by a mix of less experienced junior trainees during the NPD data collection period). One interesting observation was the avoidance of return to operating theater for donor site healing problems with the use of the NPD when compared with CPD. This equated to less patient morbidity. The cost of a 5-day course of NPD treatment was £250 ($400) for each patient, and total theater operating cost for an episode of return to theater was £900 ($1450). When analyzed from a health-economic perspective based on the outcomes of this study, the use of the NPD for 10 patients will incur £2500 ($4000) to achieve £900 ($1450) savings. However, when compared with the locally agreed tariff from the local health care commissioners for a case of microvascular free flap reconstruction, set at £16 500 ($26 700), the cost of NPD was relatively small. This would therefore suggest that the routine use of the NPD system would be difficult to justify financially. However, in the context of surgical training and exposure to the use of NPD systems, in order to maintain surgical and nursing skills in the use of the NPD, one could perhaps justify its use from the surgical education perspective.
The end points of this study could be open to criticism because the assessors and patients were not blinded. The clinical decisions made during the process of patient care and recovery had some element of subjectivity because there were no definitive diagnostic criteria or robust end point, eg, evidence of compartment syndrome, that served as a trigger to intervention. The results of a randomized controlled study would have produced a higher level of evidence. However, given the number of patients treated in 1 tertiary center, it would not have been feasible; an adequately powered study would require several hundred cases to reveal a difference in outcome. It is acknowledged that comparison between a prospective cohort and a retrospective cohort is not ideal because the data collected prospectively are often more accurate and retrospective data had the tendency to underestimate complication rates. However, because the patients in this study were recruited during an approximately 6-year period, the final study design adopted was the next best option, and we believe that it provided invaluable information in our assessment of the NPD in this context as part of our departmental service evaluation audit.
A systematic review6 of fibula donor site morbidity showed wound healing problems to occur in 3.2% to 54% of patients, and the reported rates of 47% (CPD) and 57% (NPD) in our study were in the higher end of the spectrum. Previous reports of use of the NPD in the management of free flap donor sites have focused on the forearm,13- 16 the findings of which have been summarized in Table 2. Although the multiple reported case series13,14,16 have found NPD to be beneficial in the management of radial forearm free flap donor sites, the results of a randomized controlled study did not find any significant advantage to healing conferred by the NPD.15 Our experience with the NPD system would suggest that assessment of skin graft take at day 5 is too early because we observed that there was delayed dehiscence and/or graft failure and thus decided to document graft healing at 4 to 6 weeks after surgery, which allowed a more accurate assessment. This was similarly observed by Vidrine et al,16 who reported a decrease in skin graft take rates over the early postoperative period. A systematic review17 based on reported randomized controlled studies has concluded that, to date, there is no evidence to support the use of NPD in the treatment of acute or chronic wounds. The application of a plaster splint to immobilize the lateral compartment to improve wound healing has been analyzed prospectively,4 and the reported incidence of partial or complete skin graft loss was 24%. This has not been our practice, but 1 of the reported benefits of the VAC system was reduction of shear, and in the NPD cohort reported, the skin graft loss rate was 29%. It seems that splint immobilization may improve skin graft take in the fibula donor site. This however has to be balanced against the benefits of early mobilization of patients in their rehabilitation pathway and prevention of venous thromboembolism. The best positive outcome from the present study would suggest that the NPD could at best be beneficial in decreasing return to the operating theater for donor site problems, for 1 in 10 patients, but the result was not statistically significant and was based on small numbers. This, combined with the nonrandom study design, does not provide confirmatory evidence as to whether the NPD is beneficial for skin graft take and healing of the fibula donor site.
The main focus of this study was on donor site skin graft or wound healing because this unit had previously published our experience of the fibula free flap donor site morbidity.1 In our clinical practice, the donor site morbidity of the fibular free flap remains a challenge. One possible explanation is that the loss of territorial nutritive blood supply of the peroneal artery following fibula flap harvest could not be fully compensated by the anterior and posterior tibial systems.18 It remains to be seen whether any additional information could be derived from the preoperative imaging to predict healing outcomes of the fibula donor site, and should a reliable predictive model be conceived, this could refine the process of donor site selection. Although it continues to be popular for reconstruction of composite defects in the head and neck, the morbidity of the fibula donor site may prolong the postsurgical rehabilitation process. This has to be taken into consideration in the selection of donor site when a defect-oriented and patient-oriented approach is adopted. Patients should be adequately counseled and prepared for possible prolonged wound healing and/or complications when the fibula donor site is selected for microvascular free tissue transfer.
Corresponding Author: Michael Wing Sung Ho, FRCS, DOHNS, Regional Maxillofacial Unit, Aintree University Hospitals NHS Foundation Trust, Liverpool L9 7AL, England (firstname.lastname@example.org).
Submitted for Publication: May 12, 2013; final revision received July 8, 2013; accepted July 19, 2013.
Published Online: September 5, 2013. doi:10.1001/jamaoto.2013.4544.
Author Contributions: Drs Ho and Shaw had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Ho, Rogers, Bekiroglu, Shaw.
Acquisition of data: Ho.
Analysis and interpretation of data: Ho, Rogers, Brown, Shaw.
Drafting of the manuscript: Ho, Rogers, Shaw.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Ho.
Administrative, technical, or material support: Ho, Rogers, Shaw.
Study supervision: Rogers, Brown, Bekiroglu, Shaw.
Conflict of Interest Disclosures: None reported.
Funding/Support:Regional Maxillofacial Unit, Aintree University Hospital.
Previous Presentation: This study was presented at the American Head and Neck Society Eighth International Conference on Head and Neck Cancer; July 22, 2012; Toronto, Ontario, Canada.