Introduction

During the past 60 years, surgeons and researchers have described two fundamental types of bone healing, primary and secondary. Implants and techniques were developed to reflect the understanding of these basic principles. As the concepts progressed, research was conducted to determine how surgical techniques and implant design might enhance the treatment of fractures according to a better understanding of the biomechanical and biophysiologic healing of fractures. Minimally invasive surgical techniques and other innovations directed an armamentarium for treating various types of fractures with improved outcomes by decreasing the soft tissue damage from open exposures. In parallel, principles-based curricula were developed, and together they led to success in consistent treatment of fractures across disciplines. Today spine, craniomaxillofacial (CMF), orthopedic, and veterinary surgeons approach fracture care in similar ways with a common understanding of the principles of bone healing.

In contrast, in soft tissue management (STM), anecdotal experience (generally accepted as true but may vary among specialties) has been passed on through apprenticeship teaching along with findings based on published evidence and has thus been secondary to the primary focus of bone treatment. After surgical site infection (SSI) was recognized as a major (and sometimes avoidable) problem that can lead to patient morbidity and mortality and economic burden, many reports were published on the treatment of SSI and STM education [1, 2]. Nevertheless, with the lack of clinical data and the great diversity of soft tissue injuries, tradition-based STM training programs prevailed. Thus, substantial differences still exist in soft tissue handling among surgical specialties and became a major challenge in creating unified principles—as we have experienced as a curriculum development group (CDG) representing various surgical specialties.

To overcome this difficulty for the future, we sought to find a common ground in a set of consensus statements that could serve as the basis for a cross-specialty curriculum, designed through a backward planning process [3]. In consultation with a panel of experts, the CDG generated a panel of statements based on the curriculum topics. The statements were then processed using the basic tenet of the Delphi method as has been frequently done in clinical setting when little or no definitive evidence exists, but expert opinions are important [4,5,6].

This article describes the first steps in building a cross-specialty consensus in essential areas of STM. The resulting statements can be used as a basis for developing STM curricula across disciplines and to identify potential research needs in STM.

Materials and methods

Organization

The CDG was responsible for selecting the STM topics and formulating the initial statements for a cross-specialty curriculum. The 6 CDG members were recommended by their colleagues as surgeons with expertise on soft tissue handling and ample experience in teaching the topics. The group included 3 plastic surgeons, 1 spine surgeon, 1 trauma surgeon, and 1 veterinary surgeon.

A panel of 28 international experts (i.e., the panelists, including the 6 CDG members) were invited to comment on the statements and participate in a survey. The panelists were selected for their prior experience in surgical education with emphasis on STM and were encouraged to provide literature evidence that supported or contradicted the statements. Among the panelists, 7 (25.0%) were plastic surgeons (including CMF surgeons), 4 (14.3%) were spine surgeons, 14 (50.0%) were trauma surgeons, and 3 (10.7%) were veterinary surgeons. An education specialist and a medical writer familiar with the Delphi method were included as facilitators.

Generation of the STM curriculum and consensus statements

The CDG met in person in 2018 and 2019 to define a cross-specialty STM curriculum using a backward planning process and the 6-step approach to curriculum design proposed by Kern [3, 7]. Subsequently, a first draft of statements, which had been sent to the panelists for their feedback and contribution of supporting evidence, was generated by the CDG to go through the following modified 4-stage Delphi process: (1) pilot voting: paper-based pilot voting by the CDG in-person to fine-tune the statements and to select topics for which clinical evidence was likely available for a literature review; (2) round 1 of web-based voting by the panelists; (3) in-person meeting of the CDG to examine evidence resulted from the literature review and formulate statements for round 2 of web-based voting; and (4) round 2 of web-based voting by the panelists.

All voting rounds were anonymous, so panelists could vote without the influence of others. (In theory, the 2 facilitators could identify how the panelists voted.) For each stage, the threshold was set to 80% agreement for the statement to pass as consensus.

Pilot voting

Before the CDG members met to participate in pilot voting on the initial statements, the members had received and read feedback from the panelists. The 2 facilitators conducted the meeting and recorded the voting results. The voting categories, based on the degree of confidence of a statement being true, were (1) statement can be taught as is, (2) statement can be taught with caution, (3) statement is controversial, and (4) statement should be eliminated.

If a statement received a combined vote of 80% or more for “statement can be taught as is” and “statement can be taught with caution,” the statement was retained and discussed further. The medical accuracy of the statements was verified by the CDG members, and the clarity of the language adjusted. The most controversial topics that may benefit from clinical evidence were selected for literature review. The wording of the statements was finalized by a language/education specialist before the CDG gave final approval.

Voting, rounds 1 and 2

For round 1 voting, the survey was set up in a web-based electronic data capture system [8] and sent to the panelists. Survey results were exported for descriptive statistics analyses using a user-written SAS program (SAS Institute Inc). The possible categories of votes were the same as those in the pilot voting except for the additional free-text field where panelists could provide comments. Statements that received a minimum of 80% vote for “statement can be taught as is” became consensus statements. Statements that did not reach consensus were discussed at an in-person CDG meeting and were revised (with input from the panelists’ written comments) for round 2 voting or eliminated. Additional statements were formulated from the results of the literature review.

Round 2 voting was conducted similarly except that several new, clinical evidence-based statements were added and key publications from the literature review were sent to the panelists.

Literature review

A non-systematic literature search was performed using the PubMed database for topics that were selected by the CDG during the pilot voting. The focus of the search was good-quality meta-analyses and recent review articles, but other types of articles were also reviewed.

Results

Topics and statements

Thirteen topics from the STM curriculum were selected, and 92 initial statements were formulated by the CDG. The topics were (1) wound types and clinical aspects of wound healing; (2) skin preparation and patient positioning; (3) suture materials (including barbed sutures); (4) methods of hemostasis; (5) surgical incision and exposure; (6) infection in surgical and traumatic wounds; (7) mobilization strategy; (8) penetrating wounds; (9) modifiable factors to optimize wound healing; (10) management of subacute and chronic wounds; (11) postoperative scar management; (12) treatment of soft tissue deformities and symptomatic scars; and (13) skin grafting and flaps.

After review of feedback from the panelists and the pilot voting, statements that reached the 80% approval cutoff were revised by clarifying the wording, splitting into multiple statements, or consolidating into 1 statement. After other statements and redundancies were eliminated (Table 1), 64 statements remained for round 1 voting.

Table 1 Statements eliminated after pilot testing
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The pilot voting identified 3 topics that were considered controversial but likely to have evidence in the literature: (1) operating room (OR) behavior, (2) barbed sutures (application and clinical results), and (3) application of negative pressure wound therapy (NPWT). Most statements under these topics were temporarily removed from the survey and were later reformulated for round 2 voting according to the results of the literature review. Examples of search terms for OR behavior were “operating room,” “door opening,” “surgical site infection,” “attire,” and “jewelry.” Examples for barbed sutures were “barbed sutures,” “wound closure,” “wound dehiscence,” “comparing,” and “outcome.” Examples for NPWT were “negative pressure wound therapy,” “wound contracture,” “wound healing,” “benefit,” “tissue granulation,” and “contraindicat*.”

Literature review

For each of the 3 topics, 25–30 full-text publications were evaluated. The results were collated and discussed at a CDG meeting. The collated results and a set of literature on OR behavior [9,10,11], barbed sutures [12,13,14,15], and NPWT [16,17,18] were sent to the panelists before round 2 voting.

Survey results

The number of statements at each voting stage is summarized in Fig. 1. Of the 28 panelists, 22 (78.6%) answered the round 1 survey. These 22 participants represented 4 surgical disciplines: plastic surgery (including CMF surgery) (n = 6; 27.3%); spine surgery (n = 3; 13.6%); trauma surgery (n = 10; 45.5%); and veterinary surgery (n = 3; 13.6%). Geographically, they were from North America (8), Central and South America (3), Europe (5), Asia (4), and Middle East (2). Of the 64 statements, 28 passed the 80% cutoff and could be taught without revision. Among the statements that did not reach the cutoff, 31 were revised for the round 2 survey and 5 were eliminated without further voting. The CDG formulated 7 new statements from the evidence stemming from the literature review. In total, 38 statements for round 2 voting were sent to the 22 panelists who had participated in the first round.

Fig. 1
figure 1

Flow chart showing status of statements

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The return rate for round 2 voting was 100%. Of the 38 statements included in the round 2 survey, 28 passed the 80% cutoff, so they could be taught without revision, and 10 statements did not pass the 80% cutoff. In summary, 56 statements (28 from round 1 and 28 from round 2) could be taught without revision. Table 2 summarizes these 56 consensus statements (in their final wording), and Table 3 summarizes the statements that did not make the cutoff along with selected comments from the panelists. A panelist may have voted for a statement to be taught as is but nevertheless wrote a comment, so these comments do not necessarily reflect how a panelist voted. Nevertheless, these comments supplement the statements with points to consider for teaching and may provide clues as to why a statement did not reach consensus.

Table 2 Summary of survey results for all statements
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Table 3 Failed statements and selected comments
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Discussion

Through a modified Delphi process, the 6-member, cross-specialty CDG identified 56 statements (from 92 preliminary statements) that reached 80% consensus and could be taught without revision.

Why did statements fail to reach consensus?

To understand why a statement did not reach consensus and could not be taught without revision, the CDG examined the statements along with the panelists’ comments. Some statements had insufficient detail and needed modification (e.g., statement 1.1, Table 3). Some were too general and should not be taught without qualification (e.g., statement 4.2, Table 1). Some lacked sufficient evidence, and the traditional teaching was too disparate among different surgical fields (e.g., statement 2.1 and statement 4.3, Table 3).

Wording changes and literature support that promoted consensus

An example of a statement that needed revising is statement 8.10 (“Nitropaste has little or no benefit in reducing wound healing complications in most wounds,” Table 3). Although this concept is commonly taught in the care of compromised skin, the statement did not reach consensus in round 1. After the original statement was qualified by the word minimal, it passed with 86% consensus (Table 2). Another example is statement 13.1 (“Reasonable evidence exists that the number of OR door openings during a procedure is associated with increased SSI rates”). This issue has been debated frequently, and it probably would have failed to reach consensus, but with the support of a literature review, it reached consensus on the first try (Table 2). This statement and its supporting evidence could be used to persuade hospital administrations to introduce the concept into the OR policy.

Consensus statements across specialties

We want to emphasize that the statements were developed to consider practices of different surgical specialties. While some statements may seem basic, it is reassuring that they are agreed by different specialties, as demonstrated by statements 6.1 (“SSIs are the commonest postoperative complications…”) and 6.2 (“The commonest source of SSIs is the patient’s skin flora”) (Table 2). Other statements may have been basic surgical principles based on experience and handed down as dogma; they have nevertheless reached consensus implying that they are broadly accepted by multiple specialties, such as statements 2.6 (“Adequate padding of bony prominences during patient positioning reduces pressure-related complications”) and 8.5 (“Inadequate débridement of wounds increases wound healing complications”) (Table 2).

While most of the consensus statements represent level V evidence, the use of a modified Delphi method on the experienced educators’ opinions increased the validity of the consensus statements. Smith and Pell [19] pointed out in their tongue-in-cheek article, “the basis for parachute use is purely observational, and its apparent efficacy could potentially be explained by a healthy cohort effect”; with the Delphi method, a statement recommending the use of a parachute would clearly receive greater than 80% consensus and pass in the first round. This example illustrates the many barriers to conducting higher level studies in various clinical areas. Formidable obstacles include the diversity of soft tissue injury (e.g., traumatic or intraoperative), the lack of an easy-to-use and reproducible classification system for soft tissue injury, the lack of detailed documentation of surgical techniques and follow-up, and the lack of funding for research of this type. Even when evidence exists, it is not disseminated well across specialties. In addition, we surgeons are sometimes too quick to blame patient factors (e.g., smoking, diabetes, and vascular disease) for complications with healing or infections rather than our own soft tissue handling techniques.

The purpose of this study was not only to validate a few consensus statements but also to point out how our experience in creating a cross-specialty curriculum had prompted us to reexamine how our education in STM had been done. Through the extensive discussion and a literature review, we believe some well-balanced statements have been created, and these shall be suitable for use in future STM education. The generation of these consensus statements illustrates the “one medicine, one health” concept: There are shared principles across specialties and species [20].

The current work has obvious limitations: First, the selection of the experts was not based on their research credentials in STM but on their experience, interest, and prominence in teaching. Second, choosing precise wording for consensus statements among a group of surgeons who do not share a common first language was challenging. This could have been circumvented by supplementing the statements with examples to ensure an accurate conveyance of the meaning.

Conclusions

Using a modified Delphi method, we have arrived at a set of cross-specialty consensus statements for STM. These statements are applicable across multiple surgical disciplines and can be used as a foundation for evidence-based surgical education.